[Congressional Record Volume 143, Number 129 (Wednesday, September 24, 1997)]
[Senate]
[Pages S9847-S9868]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION MODERNIZATION AND ACCOUNTABILITY ACT OF
1997
The Senate continued with the consideration of the bill.
Mr. KENNEDY. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. KENNEDY. How much time remains, Mr. President?
[[Page S9848]]
The PRESIDING OFFICER. The Senator from Massachusetts has 7 minutes.
Mr. KENNEDY. Mr. President, I yield myself 3 minutes.
Just a short while ago, we heard some comments on the floor about how
this whole process has taken a long period of time. It has taken a
period of time. But I think one can see from any fair review of the
history of the legislation that very substantial progress has been made
in making this a better bill. As I pointed out earlier in the debate,
of the 20 major health safety issues identified by the administration,
19 have been addressed, not only in our committee markup, but also in
the negotiations that we had prior to the time of the legislation
coming to the floor. There is the one remaining item, which deals with
safety and medical devices. It is extremely important. We have given
focus to this issue because it deserves the focus that we have given
it.
Mr. President, I have in my hand the statement of the administration
policy. It indicates that it has two major concerns with the bill. One
is the technical provision with regard to the budget agreement and how
they are going to allocate to PDUFA, which is a technical issue. But
the other issue mentioned by the administration is this particular
provision:
First, section 404 of the bill would lower the review
standard for marketing approval by precluding the FDA from
reviewing medical devices for uses other than those for which
the manufacturer says they are intended.
The administration indicates, as they did in the letter in September,
as they did in June, that this particular provision is dangerous in
terms of the consumers in this country.
We have reviewed, over the course of the debate, the dangerous
situations that have been the result of medical device disasters. We
are committed to avoiding that kind of disaster in the future. We have
a good safety record at the present time, but we are endangering that
record with section 404. We noted that virtually every consumer group
supports changing section 404. It is enormously important. It goes to
the fundamental question of providing FDA with the power and authority
to pursue the protections of the American health in the area of medical
devices.
Mr. President, I ask unanimous consent that the statement of the
administration policy supporting our position regarding 404 be printed
in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Executive Office of the President, Office of Management
and Budget,
Washington, DC, September 24, 1997.
Statement of Administration Policy
(This statement has been coordinated by OMB with the concerned
agencies.)
S. 830--FDA Modernization and Accountability Act of 1997
(Senator Jeffords (R) VT)
The Administration applauds the Senate for its bipartisan
effort to improve S. 830 since it was reported by the Senate
Committee on Labor and Human Resources, and appreciates the
Senate's responsiveness to concerns that have been raised.
Because of the importance of obtaining a five-year extension
of the Prescription Drug User Fee Act (PDUFA), the
Administration has no objection to passage of the bill by the
Senate at this time. However, the Administration finds that
the provisions identified below are unacceptable and as the
legislative process continues, will work to ensure that our
remaining concerns are resolved.
In general, this legislation represents a significant step
toward accomplishing our mutual goal of assuring the agency's
optimum performance while protecting the health of the
American public. The Administration, however, continues to
have two major concerns with the bill.
First, section 404 of the bill would lower the review
standard for marketing approval by precluding the Food and
Drug Administration (FDA) from reviewing new medical devices
for uses other than those for which the manufacturer says
they are intended. Second, the PDUFA trigger as proposed in
S. 830 undercuts the bipartisan budget agreement (BBA) by
requiring budget increases for FDA not envisioned by the BBA,
and would interfere with HHS' ability to allocate resources
appropriately throughout the Department.
In order to be able to support the final bill, the
Administration will continue to work with the House of
Representatives and in conference to resolve these and other
identified issues.
Mr. KENNEDY. We hope that we can be convincing as this legislation
goes forward. We have not been convincing here on the floor. We hope
provisions can be accepted that will make 404 acceptable in terms of
the public health issues. I want to express my sincere appreciation to
the chairman of the committee, Senator Jeffords, who has been a
chairman's chair. He is strong in his belief. He is a fighter for the
things that he champions. He has been willing to accommodate differing
views. He protects his strong posture and positions on his own views,
and I respect that. I thank the other Members of this body for their
courtesy during the course of what I know has been a continuing
discussion and debate on a very important measure. I thank all of our
Members for their courtesy and consideration as we move toward a vote
on this legislation. I thank my chairman.
At the time when the Senator from Vermont is prepared to yield back
his time, I will be prepared to do so likewise and move to our vote.
unanimous-consent request
Mr. JEFFORDS. Mr. President, first, I have a unanimous-consent
request, which has been cleared on both sides.
I ask unanimous consent that it be in order to consider amendment No.
1184, as modified, with changes that are at the desk; further, that the
amendment be agreed to, and the motion to reconsider be laid upon the
table.
I'm sorry, Mr. President, I withdraw that request at this moment.
The PRESIDING OFFICER. It is withdrawn.
Mr. JEFFORDS. Mr. President, first of all, I thank the ranking member
for his help on this bill. We agree on 19 out of 20 provisions. His
steadfast and articulate objection to the 20th, relative to section
404, has been done sincerely and very well done on that issue. I
believe that we have a good bill, but we remain open to suggestions, as
always, as to how the bill can be improved. I am extremely pleased that
the Senate has overwhelmingly approved S. 830 yesterday. I believe this
is an important step forward for ensuring a stronger and more efficient
FDA.
Throughout this process, we have had the benefit of input from all
interested parties on how best to modernize the Agency, while ensuring
that its stellar standard for public safety remains as strong as ever.
I am extremely proud of the strong support of this legislation
expressed by the health community. For instance, the National Health
Council, a coalition of over 100 health and patient organizations, has
urged the Senate to move forward with this legislation. We have also
received support from physician groups, including the American Medical
Association and the American Academy of Pediatrics.
We must remember that drugs and medical devices delayed at the FDA
are often lives lost. When cardiac defibrillators were first developed
in the late 1980's, they brought new hope and opportunity to many of
the 350,000 Americans who would otherwise suffer sudden cardiac death
each year.
But the first version of this technology required opening the chest
and separating the ribs to apply this technology to the heart. This
procedure carried a 4.2 percent mortality rate.
Improvements to this defibrillator technology were widely available
in Europe two years before patients could benefit in this country. The
new technology did not require cracking the patients chest, but only a
small incision to allow the technology to be threaded through a vein
into the heart.
During this unnecessary 2-year delay, it is estimated that 1,056
Americans died from complications related to the more invasive
technique. Delay does cost lives.
And far from allowing dangerous products on the market as Senator
Kennedy has alleged, section 404 of this bill keeps intact FDA's
authority to investigate technological issues which raise new safety
and effectiveness questions, does not limit FDA's enforcement
authority, and does not touch FDA's regulations which require that
medical device applications be truthful and not omit any material
facts.
[[Page S9849]]
Section 404 does quite appropriately keep FDA out of regulating the
practice of medicine. That is important and we should fight to protect
the intent of this provision.
Patients will also benefit from other provisions of the bill
including the registry of clinical trials, fast-track approval for
drugs treating life-threatening diseases, expanded access to
investigational therapies, and the incentives established to
investigate pediatric uses of drugs.
I want to thank the patient, consumer, and physician groups, and all
the others we have worked with, for their commitment to working toward
real reforms that strengthen the FDA and the contributions they have
made in crafting this bipartisan measure.
Mr. President, how much time do I have left?
The PRESIDING OFFICER. The Senator from Vermont has 9 minutes
remaining.
Mr. JEFFORDS. I yield 2 minutes to the Senator from Florida.
The PRESIDING OFFICER. The Senator from Florida is recognized.
Mr. MACK. Mr. President, I thank Senator Jeffords for yielding.
First of all, I want to commend him for a tremendous amount of work.
This is an incredibly complicated piece of legislation. It has involved
a lot of different interest groups in some issues that have become very
charged.
So I again want to thank the Senator from Vermont for his willingness
to work with Senator Frist and I as we worked on the so-called off-
label issue.
I also want to express my appreciation to Senator Kennedy. He had
some deep concerns about the legislation, and as a result of extensive
discussions we were able to find a compromise. I think it was one of
the reasons that this bill was able to move forward.
So I thank Senator Jeffords and Senator Kennedy. And I also want to
put in a comment with respect to Mark Smith, my staffer who has worked
on this issue for more than some 2\1/2\ years.
Again, I thank Senator Jeffords for what he has done.
Mr. JEFFORDS. I thank the Senator for his comments, and I want to
praise him for his efforts with respect to off-label. This is an
incredibly important amendment that Senator Mack and Senator Frist have
worked out with the FDA and the minority. That is going to give a great
deal of assistance to people in this country who are in need of help in
straightening out a relatively difficult area with such preciseness.
The Senator from Florida did a good job.
Amendment No. 1184, As Modified
Mr. President, I ask unanimous consent that it be in order to
consider amendment No. 1184, as modified, with changes that are at the
desk; further, that the amendment be agreed to, and the motion to
reconsider be laid upon the table.
The PRESIDING OFFICER. Is there objection? Without objection, it is
so ordered.
The amendment (No. 1184), as modified, was agreed to, as follows:
Strike section 809 and insert the following:
SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF
PHARMACY COMPOUNDING.
Section 503 (21 U.S.C. 353) is amended by adding at the end
the following:
``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and
507 shall not apply to a drug product if--
``(A) the drug product is compounded for an identified
individual patient, based on a medical need for a compounded
product--
``(i) by a licensed pharmacist in a State licensed pharmacy
or a Federal facility, or a licensed physician, on the
prescription order of a licensed physician or other licensed
practitioner authorized by State law to prescribe drugs; or
``(ii) by a licensed pharmacist or licensed physician in
limited quantities, prior to the receipt of a valid
prescription order for the identified individual patient, and
is compounded based on a history of the licensed pharmacist
or licensed physician receiving valid prescription orders for
the compounding of the drug product that have been generated
solely within an established relationship between the
licensed pharmacist, or licensed physician, and--
``(I) the individual patient for whom the prescription
order will be provided; or
``(II) the physician or other licensed practitioner who
will write such prescription order; and
``(B) the licensed pharmacist or licensed physician--
``(i) compounds the drug product using bulk drug
substances--
``(I) that--
``(aa) comply with the standards of an applicable United
States Pharmacopeia or National Formulary monograph; or
``(bb) in a case in which such a monograph does not exist,
are drug substances that are covered by regulations issued by
the Secretary under paragraph (3);
``(II) that are manufactured by an establishment that is
registered under section 510 (including a foreign
establishment that is registered under section 510(i)); and
``(III) that are accompanied by valid certificates of
analysis for each bulk drug substance;
``(ii) compounds the drug product using ingredients (other
than bulk drug substances) that comply with the standards of
an applicable United States Pharmacopeia or National
Formulary monograph and the United States Pharmacopeia
chapter on pharmacy compounding;
``(iii) only advertises or promotes the compounding service
provided by the licensed pharmacist or licensed physician and
does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug;
``(iv) does not compound a drug product that appears on a
list published by the Secretary in the Federal Register of
drug products that have been withdrawn or removed from the
market because such drug products or components of such drug
products have been found to be unsafe or not effective;
``(v) does not compound a drug product that is identified
by the Secretary in regulation as presenting demonstrable
difficulties for compounding that reasonably demonstrate an
adverse effect on the safety or effectiveness of that drug
product; and
``(vi) does not distribute compounded drugs outside of the
State in which the drugs are compounded, unless the principal
State agency of jurisdiction that regulates the practice of
pharmacy in such State has entered into a memorandum of
understanding with the Secretary regarding the regulation of
drugs that are compounded in the State and are distributed
outside of the State, that provides for appropriate
investigation by the State agency of complaints relating to
compounded products distributed outside of the State.
``(2)(A) The Secretary shall, after consultation with the
National Association of Boards of Pharmacy, develop a
standard memorandum of understanding for use by States in
complying with paragraph (1)(B)(vi).
``(B) Paragraph (1)(B)(vi) shall not apply to a licensed
pharmacist or licensed physician, who does not distribute
inordinate amounts of compounded products outside of the
State, until--
``(i) the date that is 180 days after the development of
the standard memorandum of understanding; or
``(ii) the date on which the State agency enters into a
memorandum of understanding under paragraph (1)(B)(vi),
whichever occurs first.
``(3) The Secretary, after consultation with the United
States Pharmacopeia Convention Incorporated, shall promulgate
regulations limiting compounding under paragraph
(1)(B)(i)(I)(bb) to drug substances that are components of
drug products approved by the Secretary and to other drug
substances as the Secretary may identify.
``(4) The provisions of paragraph (1) shall not apply--
``(A) to compounded positron emission tomography drugs as
defined in section 201(ii); or
``(B) to radiopharmaceuticals.
``(5) In this subsection, the term `compound' does not
include to mix, reconstitute, or perform another similar act,
in accordance with directions contained in approved drug
labeling provided by a drug manufacturer and other drug
manufacturer directions consistent with that labeling.''.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that Senator
Abraham be added as a cosponsor of S. 830.
The PRESIDING OFFICER. Without objection, it is so ordered.
Mr. JEFFORDS. Mr. President, if the minority is ready and will yield
all remaining time, I will yield mine.
It is my understanding the minority will yield this time. I yield the
remainder of my time.
The PRESIDING OFFICER. Without objection, the minority time is
yielded.
Mr. JEFFORDS. Mr. President, I ask unanimous consent that the
administration policy that was received as a message be printed in the
Record.
I thank them for bringing it to our attention at this time.
There being no objection, the material was ordered to be printed in
the Record, as follows:
Executive Office of the President, Office of Management,
and Budget,
Washington, DC, September 24, 1997.
Statement of Administration Policy
(THIS STATEMENT HAS BEEN COORDINATED BY OMB WITH THE CONCERNED
AGENCIES.)
S. 830--FDA Modernization and Accountability Act of 1997
(Sen. Jeffords (R) VT)
The Administration applauds the Senate for its bipartisan
effort to improve S. 830 since it was reported by the Senate
Committee on Labor and Human Resources, and appreciates the
Senate's responsiveness to concerns that have been raised.
Because of the
[[Page S9850]]
importance of obtaining a five-year extension of the
Prescription Drug User Fee Act (PDUFA), the Administration
has no objection to passage of the bill by the Senate at this
time. However, the Administration finds that the provisions
identified below are unacceptable and as the legislative
process continues, will work to ensure that our remaining
concerns are resolved.
In general, this legislation represents a significant step
toward accomplishing our mutual goal of assuring the agency's
optimum performance while protecting the health of the
American public. The Administration, however, continues to
have two major concerns with the bill.
First, section 404 of the bill would lower the review
standard for marketing approval by precluding the Food and
Drug Administration (FDA) from reviewing new medical devices
for uses other than those for which the manufacturer says
they are intended. Second, the PDUFA trigger as proposed in
S. 830 undercuts the bipartisan budget agreement (BBA) by
requiring budget increases for FDA not envisioned by the BBA,
and would interfere with HHS' ability to allocate resources
appropriately throughout the Department.
In order to be able to support the final bill, the
Administration will continue to work with the House of
Representatives and in conference to resolve these and other
identified issues.
Mr. JEFFORDS. Mr. President, I ask for the yeas and nays.
The PRESIDING OFFICER. Is there a sufficient second?
There is a sufficient second.
The yeas and nays were ordered.
The PRESIDING OFFICER. The question is on the engrossment and third
reading of the bill.
The bill was ordered to be engrossed for a third reading, and was
read the third time.
The PRESIDING OFFICER. The bill having been read the third time, the
question is, Shall it pass? On this question, the yeas and nays have
been ordered, and the clerk will call the roll.
The assistant legislative clerk called the roll.
The PRESIDING OFFICER (Mr. Santorum). Are there any other Senators in
the Chamber who desire to vote?
The result was announced--yeas 98, nays 2, as follows:
[Rollcall Vote No. 256 Leg.]
YEAS--98
Abraham
Akaka
Allard
Ashcroft
Baucus
Bennett
Biden
Bingaman
Bond
Boxer
Breaux
Brownback
Bryan
Bumpers
Burns
Byrd
Campbell
Chafee
Cleland
Coats
Cochran
Collins
Conrad
Coverdell
Craig
D'Amato
Daschle
DeWine
Dodd
Domenici
Dorgan
Durbin
Enzi
Faircloth
Feingold
Feinstein
Ford
Frist
Glenn
Gorton
Graham
Gramm
Grams
Grassley
Gregg
Hagel
Harkin
Hatch
Helms
Hollings
Hutchinson
Hutchison
Inhofe
Inouye
Jeffords
Johnson
Kempthorne
Kerrey
Kerry
Kohl
Kyl
Landrieu
Lautenberg
Leahy
Levin
Lieberman
Lott
Lugar
Mack
McCain
McConnell
Mikulski
Moseley-Braun
Moynihan
Murkowski
Murray
Nickles
Reid
Robb
Roberts
Rockefeller
Roth
Santorum
Sarbanes
Sessions
Shelby
Smith (NH)
Smith (OR)
Snowe
Specter
Stevens
Thomas
Thompson
Thurmond
Torricelli
Warner
Wellstone
Wyden
NAYS--2
Kennedy
Reed
The bill (S. 830), as amended, was passed, as follows:
S. 830
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Modernization and Accountability Act of 1997''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References.
TITLE I--IMPROVING PATIENT ACCESS
Sec. 101. Mission of the Food and Drug Administration.
Sec. 102. Expanded access to investigational therapies.
Sec. 103. Expanded humanitarian use of devices.
TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES
Sec. 201. Interagency collaboration.
Sec. 202. Sense of the committee regarding mutual recognition
agreements and global harmonization efforts.
Sec. 203. Contracts for expert review.
Sec. 204. Accredited-party reviews.
Sec. 205. Device performance standards.
TITLE III--IMPROVING COLLABORATION AND COMMUNICATION
Sec. 301. Collaborative determinations of device data requirements.
Sec. 302. Collaborative review process.
TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES
Sec. 401. Policy statements.
Sec. 402. Product classification.
Sec. 403. Use of data relating to premarket approval.
Sec. 404. Consideration of labeling claims for product review.
Sec. 405. Certainty of review timeframes.
Sec. 406. Limitations on initial classification determinations.
Sec. 407. Clarification with respect to a general use and specific use
of a device.
Sec. 408. Clarification of the number of required clinical
investigations for approval.
Sec. 409. Prohibited acts.
TITLE V--IMPROVING ACCOUNTABILITY
Sec. 501. Agency plan for statutory compliance and annual report.
TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES
Sec. 601. Minor modifications.
Sec. 602. Environmental impact review.
Sec. 603. Exemption of certain classes of devices from premarket
notification requirement.
Sec. 604. Evaluation of automatic class III designation.
Sec. 605. Secretary's discretion to track devices.
Sec. 606. Secretary's discretion to conduct postmarket surveillance.
Sec. 607. Reporting.
Sec. 608. Pilot and small-scale manufacture.
Sec. 609. Requirements for radiopharmaceuticals.
Sec. 610. Modernization of regulation of biological products.
Sec. 611. Approval of supplemental applications for approved products.
Sec. 612. Health care economic information.
Sec. 613. Expediting study and approval of fast track drugs.
Sec. 614. Manufacturing changes for drugs and biologics.
Sec. 615. Data requirements for drugs and biologics.
Sec. 616. Food contact substances.
Sec. 617. Health claims for food products.
Sec. 618. Pediatric studies marketing exclusivity.
Sec. 619. Positron emission tomography.
Sec. 620. Disclosure.
Sec. 621. Referral statements relating to food nutrients.
TITLE VII--FEES RELATING TO DRUGS
Sec. 701. Short title.
Sec. 702. Findings.
Sec. 703. Definitions.
Sec. 704. Authority to assess and use drug fees.
Sec. 705. Annual reports.
Sec. 706. Effective date.
Sec. 707. Termination of effectiveness.
TITLE VIII--MISCELLANEOUS
Sec. 801. Registration of foreign establishments.
Sec. 802. Elimination of certain labeling requirements.
Sec. 803. Clarification of seizure authority.
Sec. 804. Intramural research training award program.
Sec. 805. Device samples.
Sec. 806. Interstate commerce.
Sec. 807. National uniformity for nonprescription drugs and cosmetics.
Sec. 808. Information program on clinical trials for serious or life-
threatening diseases.
Sec. 809. Application of Federal law to the practice of pharmacy
compounding.
Sec. 810. Reports of postmarketing approval studies.
Sec. 811. Information exchange.
Sec. 812. Reauthorization of clinical pharmacology program.
Sec. 813. Monograph for sunburn products.
Sec. 814. Safety report disclaimers.
SEC. 3. REFERENCES.
Except as otherwise expressly provided, wherever in this
Act an amendment or repeal is expressed in terms of an
amendment to, or repeal of, a section or other provision, the
reference shall be considered to be made to a section or
other provision of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321 et seq.).
TITLE I--IMPROVING PATIENT ACCESS
SEC. 101. MISSION OF THE FOOD AND DRUG ADMINISTRATION.
Section 903 (21 U.S.C. 393) is amended--
(1) by redesignating subsections (b) and (c) as subsections
(c) and (d), respectively; and
(2) by inserting after subsection (a) the following:
``(b) Mission.--
``(1) In general.--The Secretary, acting through the
Commissioner, and in consultation, as determined appropriate
by the Secretary, with experts in science, medicine, and
public health, and in cooperation with consumers, users,
manufacturers, importers, packers, distributors, and
retailers of regulated products, shall protect the public
health by taking actions that help ensure that--
``(A) foods are safe, wholesome, sanitary, and properly
labeled;
[[Page S9851]]
``(B) human and veterinary drugs, including biologics, are
safe and effective;
``(C) there is reasonable assurance of safety and
effectiveness of devices intended for human use;
``(D) cosmetics are safe; and
``(E) public health and safety are protected from
electronic product radiation.
``(2) Special rules.--The Secretary, acting through the
Commissioner, shall promptly and efficiently review clinical
research and take appropriate action on the marketing of
regulated products in a manner that does not unduly impede
innovation or product availability. The Secretary, acting
through the Commissioner, shall participate with other
countries to reduce the burden of regulation, to harmonize
regulatory requirements, and to achieve appropriate
reciprocal arrangements with other countries.''.
SEC. 102. EXPANDED ACCESS TO INVESTIGATIONAL THERAPIES.
Chapter V (21 U.S.C. 351 et seq.) is amended by adding at
the end the following:
``Subchapter D--Unapproved Therapies and Diagnostics
``SEC. 551. EXPANDED ACCESS TO UNAPPROVED THERAPIES AND
DIAGNOSTICS.
``(a) Emergency Situations.--The Secretary may, under
appropriate conditions determined by the Secretary, authorize
the shipment of investigational drugs (including
investigational biological products), or investigational
devices, (as defined in regulations prescribed by the
Secretary) for the diagnosis, monitoring, or treatment of a
serious disease or condition in emergency situations.
``(b) Individual Patient Access to Investigational Products
Intended for Serious Diseases.--Any person, acting through a
physician licensed in accordance with State law, may request
from a manufacturer or distributor, and any manufacturer or
distributor may provide to such physician after compliance
with the provisions of this subsection, an investigational
drug (including an investigational biological product), or
investigational device, (as defined in regulations prescribed
by the Secretary) for the diagnosis, monitoring, or treatment
of a serious disease or condition if--
``(1) the licensed physician determines that the person has
no comparable or satisfactory alternative therapy available
to diagnose, monitor, or treat the disease or condition
involved, and that the risk to the person from the
investigational drug or investigational device is not greater
than the risk from the disease or condition;
``(2) the Secretary determines that there is sufficient
evidence of safety and effectiveness to support the use of
the investigational drug or investigational device in the
case described in paragraph (1);
``(3) the Secretary determines that provision of the
investigational drug or investigational device will not
interfere with the initiation, conduct, or completion of
clinical investigations to support marketing approval; and
``(4) the product sponsor, or clinical investigator, of the
investigational drug or investigational device submits to the
Secretary a clinical protocol consistent with the provisions
of section 505(i) or 520(g) and any regulations promulgated
under section 505(i) or 520(g) describing the use of
investigational drugs or investigational devices in a single
patient or a small group of patients.
``(c) Treatment INDs/IDEs.--Upon submission by a product
sponsor or a physician of a protocol intended to provide
widespread access to an investigational product for eligible
patients, the Secretary shall permit an investigational drug
(including an investigational biological product) or
investigational device to be made available for expanded
access under a treatment investigational new drug application
or investigational device exemption (as the terms are
described in regulations prescribed by the Secretary) if the
Secretary determines that--
``(1) under the treatment investigational new drug
application or investigational device exemption, the
investigational drug or investigational device is intended
for use in the diagnosis, monitoring, or treatment of a
serious or immediately life-threatening disease or condition;
``(2) there is no comparable or satisfactory alternative
therapy available to diagnose, monitor, or treat that stage
of disease or condition in the population of patients to
which the investigational drug or investigational device is
intended to be administered;
``(3)(A) the investigational drug or investigational device
is under investigation in a controlled clinical trial for the
use described in paragraph (1) under an effective
investigational new drug application or investigational
device exemption; and
``(B) all clinical trials necessary for approval of that
use of the investigational drug or investigational device
have been completed;
``(4) the sponsor of the controlled clinical trials is
actively pursuing marketing approval of the investigational
drug or investigational device for the use described in
paragraph (1) with due diligence;
``(5) the provision of the investigational drug or
investigational device will not interfere with the enrollment
of patients in ongoing clinical investigations under section
505(i) or 520(g);
``(6) in the case of serious diseases, there is sufficient
evidence of safety and effectiveness to support the use
described in paragraph (1); and
``(7) in the case of immediately life-threatening diseases,
the available scientific evidence, taken as a whole, provides
a reasonable basis to conclude that the product may be
effective for its intended use and would not expose patients
to an unreasonable and significant risk of illness or injury.
A protocol submitted under this subsection shall be subject
to the provisions of section 505(i) or 520(g) and regulations
promulgated under section 505(i) or 520(g). The Secretary may
inform national, State, and local medical associations and
societies, voluntary health associations, and other
appropriate persons about the availability of an
investigational drug or investigational device under expanded
access protocols submitted under this subsection. The
information provided by the Secretary, in accordance with the
preceding sentence, shall be of the same type of information
that is required by section 402(j)(3).
``(d) Termination.--The Secretary may, at any time, with
respect to a person, manufacturer, or distributor described
in this section, terminate expanded access provided under
this section for an investigational drug (including an
investigational biological product) or investigational device
if the requirements under this section are no longer met.''.
SEC. 103. EXPANDED HUMANITARIAN USE OF DEVICES.
Section 520(m) (21 U.S.C. 360j(m)) is amended--
(1) in paragraph (2), by adding at the end the following
flush sentences:
``The request shall be in the form of an application
submitted to the Secretary. Not later than 75 days after the
date of the receipt of the application, the Secretary shall
issue an order approving or denying the application.'';
(2) in paragraph (4)--
(A) in subparagraph (B), by inserting after ``(2)(A)'' the
following: ``, unless a physician determines that waiting for
such an approval from an institutional review committee will
cause harm or death to a patient, and makes a good faith
effort to obtain the approval, and does not receive a timely
response from an institutional review committee on the
request of the physician for approval to use the device for
such treatment or diagnosis''; and
(B) by adding at the end the following flush sentences:
``In a case in which a physician described in subparagraph
(B) uses a device without an approval from an institutional
review committee, the physician shall, after the use of the
device, notify the chairperson of the institutional review
committee of such use. Such notification shall include the
identification of the patient involved, the date on which the
device was used, and the reason for the use.''; and
(3) by striking paragraph (5) and inserting the following:
``(5) The Secretary may require a person granted an
exemption under paragraph (2) to demonstrate continued
compliance with the requirements of this subsection if the
Secretary believes such demonstration to be necessary to
protect the public health or if the Secretary has reason to
believe that the criteria for the exemption are no longer
met.''.
TITLE II--INCREASING ACCESS TO EXPERTISE AND RESOURCES
SEC. 201. INTERAGENCY COLLABORATION.
Section 903(b) (21 U.S.C. 393(b)), as added by section
101(2), is amended by adding at the end the following:
``(3) Interagency collaboration.--The Secretary shall
implement programs and policies that will foster
collaboration between the Administration, the National
Institutes of Health, and other science-based Federal
agencies, to enhance the scientific and technical expertise
available to the Secretary in the conduct of the duties of
the Secretary with respect to the development, clinical
investigation, evaluation, and postmarket monitoring of
emerging medical therapies, including complementary
therapies, and advances in nutrition and food science.''.
SEC. 202. SENSE OF THE COMMITTEE REGARDING MUTUAL RECOGNITION
AGREEMENTS AND GLOBAL HARMONIZATION EFFORTS.
It is the sense of the Committee on Labor and Human
Resources of the Senate that--
(1) the Secretary of Health and Human Services should
support the Office of the United States Trade Representative,
in consultation with the Secretary of Commerce, in efforts to
move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products,
devices, foods, food additives, and color additives, and the
regulation of good manufacturing practices, between the
European Union and the United States;
(2) the Secretary of Health and Human Services should
regularly participate in meetings with representatives of
other foreign governments to discuss and reach agreement on
methods and approaches to harmonize regulatory requirements;
and
(3) the Office of International Relations of the Department
of Health and Human Services (as established under section
803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
383)) should have the responsibility of ensuring that the
process of harmonizing international regulatory requirements
is continuous.
SEC. 203. CONTRACTS FOR EXPERT REVIEW.
Chapter IX (21 U.S.C. 391 et seq.) is amended by adding at
the end the following:
[[Page S9852]]
``SEC. 906. CONTRACTS FOR EXPERT REVIEW.
``(a) In General.--
``(1) Authority.--The Secretary may enter into a contract
with any organization or any individual (who is not an
employee of the Department) with expertise in a relevant
discipline, to review, evaluate, and make recommendations to
the Secretary on part or all of any application or submission
(including a petition, notification, and any other similar
form of request) made under this Act for the approval or
classification of an article or made under section 351(a) of
the Public Health Service Act (42 U.S.C. 262(a)) with respect
to a biological product. Any such contract shall be subject
to the requirements of section 708 relating to the
confidentiality of information.
``(2) Increased efficiency and expertise through
contracts.--The Secretary shall use the authority granted in
paragraph (1) whenever the Secretary determines that a
contract described in paragraph (1) will improve the
timeliness or quality of the review of an application or
submission described in paragraph (1), unless using such
authority would reduce the quality, or unduly increase the
cost, of such review. Such improvement may include providing
the Secretary increased scientific or technical expertise
that is necessary to review or evaluate new therapies and
technologies.
``(b) Review of Expert Review.--
``(1) In general.--Subject to paragraph (2), the official
of the Food and Drug Administration responsible for any
matter for which expert review is used pursuant to subsection
(a) shall review the recommendations of the organization or
individual who conducted the expert review and shall make a
final decision regarding the matter within 60 days after
receiving the recommendations.
``(2) Limitation.--A final decision under paragraph (1)
shall be made within the applicable prescribed time period
for review of the matter as set forth in this Act or in the
Public Health Service Act (42 U.S.C. 201 et seq.).
``(3) Authority of secretary.--Notwithstanding subsection
(a), the Secretary shall retain full authority to make
determinations with respect to the approval or disapproval of
an article under this Act, the approval or disapproval of a
biologics license with respect to a biological product under
section 351(a) of the Public Health Service Act, or the
classification of an article as a device under section
513(f)(1).''.
SEC. 204. ACCREDITED-PARTY REVIEWS.
(a) In General.--Subchapter A of chapter V (21 U.S.C. 351
et seq.) is amended by adding at the end the following:
``SEC. 523. ACCREDITED-PARTY PARTICIPATION.
``(a) Accreditation.--Not later than 1 year after the date
of enactment of this section, the Secretary shall accredit
entities or individuals who are not employees of the Federal
Government to review reports made to the Secretary under
section 510(k) for devices and make recommendations to the
Secretary regarding the initial classification of such
devices under section 513(f)(1), except that this paragraph
shall not apply to a report made to the Secretary under
section 510(k) for a device that is--
``(1) for a use in supporting or sustaining human life;
``(2) for implantation in the human body for more than 1
year; or
``(3) for a use that is of substantial importance in
preventing the impairment of human health.
``(b) Accreditation.--Within 180 days after the date of
enactment of this section, the Secretary shall adopt methods
of accreditation that ensure that entities or individuals who
conduct reviews and make recommendations under this section
are qualified, properly trained, knowledgeable about handling
confidential documents and information, and free of conflicts
of interest. The Secretary shall publish the methods of
accreditation in the Federal Register on the adoption of the
methods.
``(c) Withdrawal of Accreditation.--The Secretary may
suspend or withdraw the accreditation of any entity or
individual accredited under this section, after providing
notice and an opportunity for an informal hearing, if such
entity or individual acts in a manner that is substantially
not in compliance with the requirements established by the
Secretary under subsection (b), including the failure to
avoid conflicts of interest, the failure to protect
confidentiality of information, or the failure to competently
review premarket submissions for devices.
``(d) Selection and Compensation.--A person who intends to
make a report described in subsection (a) to the Secretary
shall have the option to select an accredited entity or
individual to review such report. Upon the request by a
person to have a report reviewed by an accredited entity or
individual, the Secretary shall identify for the person no
less than 2 accredited entities or individuals from whom the
selection may be made. Compensation for an accredited entity
or individual shall be determined by agreement between the
accredited entity or individual and the person who engages
the services of the accredited entity or individual and shall
be paid by the person who engages such services.
``(e) Review by Secretary.--
``(1) In general.--The Secretary shall require an
accredited entity or individual, upon making a recommendation
under this section with respect to an initial classification
of a device, to notify the Secretary in writing of the
reasons for such recommendation.
``(2) Time period for review.--Not later than 30 days after
the date on which the Secretary is notified under paragraph
(1) by an accredited entity or individual with respect to a
recommendation of an initial classification of a device, the
Secretary shall make a determination with respect to the
initial classification.
``(3) Special rule.--The Secretary may change the initial
classification under section 513(f)(1) that is recommended by
the accredited entity or individual under this section, and
in such case shall notify in writing the person making the
report described in subsection (a) of the detailed reasons
for the change.
``(f) Duration.--The authority provided by this section
terminates--
``(1) 5 years after the date on which the Secretary
notifies Congress that at least 2 persons accredited under
subsection (b) are available to review at least 60 percent of
the submissions under section 510(k); or
``(2) 4 years after the date on which the Secretary
notifies Congress that at least 35 percent of the devices
that are subject to review under subsection (a), and that
were the subject of final action by the Secretary in the
fiscal year preceding the date of such notification, were
reviewed by the Secretary under subsection (e),
whichever occurs first.
``(g) Report.--
``(1) In general.--Not later than 1 year after the date of
enactment of this section, the Secretary shall contract with
an independent research organization to prepare and submit to
the Secretary a written report examining the use of
accredited entities and individuals to conduct reviews under
this section. The Secretary shall submit the report to
Congress not later than 6 months prior to the conclusion of
the applicable period described in subsection (f).
``(2) Contents.--The report by the independent research
organization described in paragraph (1) shall identify the
benefits or detriments to public and patient health of using
accredited entities and individuals to conduct such reviews,
and shall summarize all relevant data, including data on the
review of accredited entities and individuals (including data
on the review times, recommendations, and compensation of the
entities and individuals), and data on the review of the
Secretary (including data on the review times, changes, and
reasons for changes of the Secretary).''.
(b) Recordkeeping.--Section 704 (21 U.S.C. 374) is amended
by adding at the end the following:
``(f)(1) A person accredited under section 523 to review
reports made under section 510(k) and make recommendations of
initial classifications of devices to the Secretary shall
maintain records documenting the training qualifications of
the person and the employees of the person, the procedures
used by the person for handling confidential information, the
compensation arrangements made by the person in accordance
with section 523(d), and the procedures used by the person to
identify and avoid conflicts of interest. Upon the request of
an officer or employee designated by the Secretary, the
person shall permit the officer or employee, at all
reasonable times, to have access to, to copy, and to verify,
the records.
``(2) Within 15 days after the receipt of a written request
from the Secretary to a person accredited under section 523
for copies of records described in paragraph (1), the person
shall produce the copies of the records at the place
designated by the Secretary.''.
SEC. 205. DEVICE PERFORMANCE STANDARDS.
(a) Alternative Procedure.--Section 514 (21 U.S.C. 360d) is
amended by adding at the end the following:
``Recognition of a Standard
``(c)(1)(A) In addition to establishing performance
standards under this section, the Secretary may, by
publication in the Federal Register, recognize all or part of
a performance standard established by a nationally or
internationally recognized standard development organization
for which a person may submit a declaration of conformity in
order to meet premarket submission requirements or other
requirements under this Act to which such standards are
applicable.
``(B) If a person elects to use a performance standard
recognized by the Secretary under subparagraph (A) to meet
the requirements described in subparagraph (A), the person
shall provide a declaration of conformity to the Secretary
that certifies that the device is in conformity with such
standard. A person may elect to use data, or information,
other than data required by a standard recognized under
subparagraph (A) to fulfill or satisfy any requirement under
this Act.
``(2) The Secretary may withdraw such recognition of a
performance standard through publication of a notice in the
Federal Register that the Secretary will no longer recognize
the standard, if the Secretary determines that the standard
is no longer appropriate for meeting the requirements under
this Act.
``(3)(A) Subject to subparagraph (B), the Secretary shall
accept a declaration of conformity that a device is in
conformity with a standard recognized under paragraph (1)
unless the Secretary finds--
``(i) that the data or information submitted to support
such declaration does not demonstrate that the device is in
conformity with the standard identified in the declaration of
conformity; or
``(ii) that the standard identified in the declaration of
conformity is not applicable to the particular device under
review.
[[Page S9853]]
``(B) The Secretary may request, at any time, the data or
information relied on by the person to make a declaration of
conformity with respect to a standard recognized under
paragraph (1).
``(C) A person relying on a declaration of conformity with
respect to a standard recognized under paragraph (1) shall
maintain the data and information demonstrating conformity of
the device to the standard for a period of 2 years after the
date of the classification or approval of the device by the
Secretary or a period equal to the expected design life of
the device, whichever is longer.''.
(b) Section 301.--Section 301 (21 U.S.C. 331) is amended by
adding at the end the following:
``(x) The falsification of a declaration of conformity
submitted under subsection (c) of section 514 or the failure
or refusal to provide data or information requested by the
Secretary under section 514(c)(3).''.
(c) Section 501.--Section 501(e) (21 U.S.C. 351(e)) is
amended--
(1) by striking ``(e)'' and inserting ``(e)(1)''; and
(2) by inserting at the end the following:
``(2) If it is declared to be, purports to be, or is
represented as, a device that is in conformity with any
performance standard recognized under section 514(c) unless
such device is in all respects in conformity with such
standard.''.
TITLE III--IMPROVING COLLABORATION AND COMMUNICATION
SEC. 301. COLLABORATIVE DETERMINATIONS OF DEVICE DATA
REQUIREMENTS.
Section 513(a)(3) (21 U.S.C. 360c(a)(3)) is amended by
adding at the end the following:
``(C)(i)(I) The Secretary, upon the written request of any
person intending to submit an application under section 515,
shall meet with such person to determine the type of valid
scientific evidence (within the meaning of subparagraphs (A)
and (B)) that will be necessary to demonstrate the
effectiveness of a device for the conditions of use proposed
by such person, to support an approval of an application. The
written request shall include a detailed description of the
device, a detailed description of the proposed conditions of
use of the device, a proposed plan for determining whether
there is a reasonable assurance of effectiveness, and, if
available, information regarding the expected performance
from the device. Within 30 days after such meeting, the
Secretary shall specify in writing the type of valid
scientific evidence that will provide a reasonable assurance
that a device is effective under the conditions of use
proposed by such person.
``(II) Any clinical data, including 1 or more well-
controlled investigations, specified in writing by the
Secretary for demonstrating a reasonable assurance of device
effectiveness shall be specified as a result of a
determination by the Secretary--
``(aa) that such data are necessary to establish device
effectiveness; and
``(bb) that no other less burdensome means of evaluating
device effectiveness is available that would have a
reasonable likelihood of resulting in an approval.
``(ii) The determination of the Secretary with respect to
the specification of valid scientific evidence under clause
(i) shall be binding upon the Secretary, unless such
determination by the Secretary could be contrary to the
public health.''.
SEC. 302. COLLABORATIVE REVIEW PROCESS.
Section 515(d) (21 U.S.C. 360e(d)) is amended--
(1) in paragraph (1)(A), by striking ``paragraph (2) of
this subsection'' each place it appears and inserting
``paragraph (4)'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively; and
(3) by inserting after paragraph (1) the following:
``(2)(A)(i) The Secretary shall, upon the written request
of an applicant, meet with the applicant, not later than 100
days after the receipt of an application from the applicant
that has been filed as complete under subsection (c), to
discuss the review status of the application.
``(ii) If the application does not appear in a form that
would require an approval under this subsection, the
Secretary shall in writing, and prior to the meeting, provide
to the applicant a description of any deficiencies in the
application identified by the Secretary based on an interim
review of the entire application and identify the information
that is required to correct those deficiencies.
``(iii) The Secretary and the applicant may, by mutual
consent, establish a different schedule for a meeting
required under this paragraph.
``(B) The Secretary shall notify the applicant immediately
of any deficiency identified in the application that was not
described as a deficiency in the written description provided
by the Secretary under subparagraph (A).''.
TITLE IV--IMPROVING CERTAINTY AND CLARITY OF RULES
SEC. 401. POLICY STATEMENTS.
Section 701(a) (21 U.S.C. 371(a)) is amended--
(1) by striking ``(a) The'' and inserting ``(a)(1) The'';
and
(2) by adding at the end the following:
``(2) Not later than February 27, 1999, the Secretary,
after evaluating the effectiveness of the Good Guidance
Practices document published in the Federal Register at 62
Fed. Reg. 8961, shall promulgate a regulation specifying the
policies and procedures of the Food and Drug Administration
for the development, issuance, and use of guidance
documents.''.
SEC. 402. PRODUCT CLASSIFICATION.
Chapter VII (21 U.S.C. 371 et seq.) is amended by adding at
the end the following:
``Subchapter D--Classification of Products and Environmental Impact
Reviews
``SEC. 741. CLASSIFICATION OF PRODUCTS.
``(a) Request.--A person who submits an application or
submission (including a petition, notification, and any other
similar form of request) under this Act, may submit a request
to the Secretary respecting the classification of an article
as a drug, biological product, device, or a combination
product subject to section 503(g) or respecting the component
of the Food and Drug Administration that will regulate the
article. In submitting the request, the person shall
recommend a classification for the article, or a component to
regulate the article, as appropriate.
``(b) Statement.--Not later than 60 days after the receipt
of the request described in subsection (a), the Secretary
shall determine the classification of the article or the
component of the Food and Drug Administration that will
regulate the article and shall provide to the person a
written statement that identifies the classification of the
article or the component of the Food and Drug Administration
that will regulate the article and the reasons for such
determination. The Secretary may not modify such statement
except with the written consent of the person or for public
health reasons.
``(c) Inaction of Secretary.--If the Secretary does not
provide the statement within the 60-day period described in
subsection (b), the recommendation made by the person under
subsection (a) shall be considered to be a final
determination by the Secretary of the classification of the
article or the component of the Food and Drug Administration
that will regulate the article and may not be modified by the
Secretary except with the written consent of the person or
for public health reasons.''.
SEC. 403. USE OF DATA RELATING TO PREMARKET APPROVAL.
(a) In General.--Section 520(h)(4) (21 U.S.C. 360j(h)(4))
is amended to read as follows:
``(4)(A) Any information contained in an application for
premarket approval filed with the Secretary pursuant to
section 515(c) (including information from clinical and
preclinical tests or studies that demonstrate the safety and
effectiveness of a device, but excluding descriptions of
methods of manufacture and product composition) shall be
available, 6 years after the application has been approved by
the Secretary, for use by the Secretary in--
``(i) approving another device;
``(ii) determining whether a product development protocol
has been completed, under section 515 for another device;
``(iii) establishing a performance standard or special
control under this Act; or
``(iv) classifying or reclassifying another device under
section 513 and subsection (l)(2).
``(B) The publicly available detailed summaries of
information respecting the safety and effectiveness of
devices required by paragraph (1)(A) shall be available for
use by the Secretary as the evidentiary basis for the agency
actions described in subparagraph (A).''.
(b) Conforming Amendment.--Section 517(a) (21 U.S.C.
360g(a)) is amended--
(1) in paragraph (8), by adding ``or'' at the end;
(2) in paragraph (9), by striking ``, or'' and inserting a
comma; and
(3) by striking paragraph (10).
SEC. 404. CONSIDERATION OF LABELING CLAIMS FOR PRODUCT
REVIEW.
(a) Premarket Approval.--Section 515(d)(1)(A) (21 U.S.C.
360e(d)(1)(A)) is amended by adding at the end the following
flush sentences:
``In making the determination whether to approve or deny the
application, the Secretary shall rely on the conditions of
use included in the proposed labeling as the basis for
determining whether or not there is a reasonable assurance of
safety and effectiveness, if the proposed labeling is neither
false nor misleading. In determining whether or not such
labeling is false or misleading, the Secretary shall fairly
evaluate all material facts pertinent to the proposed
labeling.''.
(b) Premarket Notification.--Section 513(i)(1) (21 U.S.C.
360c(i)(1)) is amended by adding at the end the following:
``(C) Whenever the Secretary requests information to
demonstrate that the devices with differing technological
characteristics are substantially equivalent, the Secretary
shall only request information that is necessary to make a
substantial equivalence determination. In making such a
request, the Secretary shall consider the least burdensome
means of demonstrating substantial equivalence and shall
request information accordingly.
``(D) The determination of the Secretary under this
subsection and section 513(f)(1) with respect to the intended
use of a device shall be based on the intended use included
in the proposed labeling of the device submitted in a report
under section 510(k).''.
(c) Rule of Construction.--Nothing in the amendments made
by subsections (a) and (b) shall be construed to alter any
authority of the Secretary of Health and Human Services to
regulate any tobacco product, or any additive or ingredient
of a tobacco product.
[[Page S9854]]
SEC. 405. CERTAINTY OF REVIEW TIMEFRAMES.
(a) Clarification on the 90-Day Timeframe for Premarket
Notification Reviews.--Section 510(k) (21 U.S.C. 360) is
amended by adding at the end the following flush sentence:
``The Secretary shall review the report required by this
subsection and make a determination under section 513(f)(1)
not later than 90 days after receiving the report.''.
(b) One-Cycle Review.--Section 515(d) (21 U.S.C. 360e(d)),
as amended by section 302, is amended by inserting after
paragraph (2) the following:
``(3) Except as provided in paragraph (1), the period for
the review of an application by the Secretary under this
subsection shall be not more than 180 days. Such period may
not be restarted or extended even if the application is
amended. The Secretary is not required to review a major
amendment to an application, unless the amendment is made in
response to a request by the Secretary for information.''.
SEC. 406. LIMITATIONS ON INITIAL CLASSIFICATION
DETERMINATIONS.
Section 510 (21 U.S.C. 360) is amended by adding at the end
the following:
``(m) The Secretary may not withhold a determination of the
initial classification of a device under section 513(f)(1)
because of a failure to comply with any provision of this Act
that is unrelated to a substantial equivalence decision,
including a failure to comply with the requirements relating
to good manufacturing practices under section 520(f).''.
SEC. 407. CLARIFICATION WITH RESPECT TO A GENERAL USE AND
SPECIFIC USE OF A DEVICE.
Not later than 270 days after the date of enactment of this
section, the Secretary of Health and Human Services shall
promulgate a final regulation specifying the general
principles that the Secretary of Health and Human Services
will consider in determining when a specific intended use of
a device is not reasonably included within a general use of
such device for purposes of a determination of substantial
equivalence under section 513(f)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(f)(1)).
SEC. 408. CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL
INVESTIGATIONS FOR APPROVAL.
(a) Device Classes.--Section 513(a)(3)(A) (21 U.S.C.
360c(a)(3)(A)) is amended by striking ``clinical
investigations'' and inserting ``1 or more clinical
investigations''.
(b) New Drugs.--Section 505(d) (21 U.S.C. 355(d)) is
amended by adding at the end the following: ``Substantial
evidence may, as appropriate, consist of data from 1 adequate
and well-controlled clinical investigation and confirmatory
evidence (obtained prior to or after such investigation), if
the Secretary determines, based on relevant science, that
such data and evidence are sufficient to establish
effectiveness.''.
SEC. 409. PROHIBITED ACTS.
Section 301(l) (21 U.S.C. 331(l)) is repealed.
TITLE V--IMPROVING ACCOUNTABILITY
SEC. 501. AGENCY PLAN FOR STATUTORY COMPLIANCE AND ANNUAL
REPORT.
Section 903(b) (21 U.S.C. 393(b)), as amended by section
201, is further amended by adding at the end the following:
``(4) Agency plan for statutory compliance.--
``(A) In general.--Not later than 180 days after the date
of enactment of this paragraph, the Secretary, after
consultation with relevant experts, health care
professionals, representatives of patient and consumer
advocacy groups, and the regulated industry, shall develop
and publish in the Federal Register a plan bringing the
Secretary into compliance with each of the obligations of the
Secretary under this Act and other relevant statutes. The
Secretary shall biannually review the plan and shall revise
the plan as necessary, in consultation with such persons.
``(B) Objectives of agency plan.--The plan required by
subparagraph (A) shall establish objectives, and mechanisms
to be used by the Secretary, acting through the Commissioner,
including objectives and mechanisms that--
``(i) minimize deaths of, and harm to, persons who use or
may use an article regulated under this Act;
``(ii) maximize the clarity of, and the availability of
information about, the process for review of applications and
submissions (including petitions, notifications, and any
other similar forms of request) made under this Act,
including information for potential consumers and patients
concerning new products;
``(iii) implement all inspection and postmarket monitoring
provisions of this Act by July 1, 1999;
``(iv) ensure access to the scientific and technical
expertise necessary to ensure compliance by the Secretary
with the statutory obligations described in subparagraph (A);
``(v) establish a schedule to bring the Administration into
full compliance by July 1, 1999, with the time periods
specified in this Act for the review of all applications and
submissions described in clause (ii) and submitted after the
date of enactment of this paragraph; and
``(vi) reduce backlogs in the review of all applications
and submissions described in clause (ii) for any article with
the objective of eliminating all backlogs in the review of
the applications and submissions by January 1, 2000.
``(5) Annual report.--
``(A) Contents.--The Secretary shall prepare and publish in
the Federal Register and solicit public comment on an annual
report that--
``(i) provides detailed statistical information on the
performance of the Secretary under the plan described in
paragraph (4);
``(ii) compares such performance of the Secretary with the
objectives of the plan and with the statutory obligations of
the Secretary;
``(iii) analyzes any failure of the Secretary to achieve
any objective of the plan or to meet any statutory
obligation;
``(iv) identifies any regulatory policy that has a
significant impact on compliance with any objective of the
plan or any statutory obligation; and
``(v) sets forth any proposed revision to any such
regulatory policy, or objective of the plan that has not been
met.
``(B) Statistical information.--The statistical information
described in subparagraph (A)(i) shall include a full
statistical presentation relating to all applications and
submissions (including petitions, notifications, and any
other similar forms of request) made under this Act and
approved or subject to final action by the Secretary during
the year covered by the report. In preparing the statistical
presentation, the Secretary shall take into account the date
of--
``(i) the submission of any investigational application;
``(ii) the application of any clinical hold;
``(iii) the submission of any application or submission
(including a petition, notification, and any other similar
form of request) made under this Act for approval or
clearance;
``(iv) the acceptance for filing of any application or
submission described in clause (iii) for approval or
clearance;
``(v) the occurrence of any unapprovable action;
``(vi) the occurrence of any approvable action; and
``(vii) the approval or clearance of any application or
submission described in clause (iii).
``(C) Special rule.--If the Secretary provides information
in a report required by section 705 of the Food and Drug
Administration Modernization and Accountability Act of 1997
or a report required by the amendments made by the Government
Performance and Results Act of 1993 and that information is
required by this paragraph, the report shall be deemed to
satisfy the requirements of this paragraph relating to that
information.''.
TITLE VI--BETTER ALLOCATION OF RESOURCES BY SETTING PRIORITIES
SEC. 601. MINOR MODIFICATIONS.
(a) Action on Investigational Device Exemptions.--Section
520(g) (21 U.S.C. 360j(g)) is amended by adding at the end
the following:
``(6)(A) The Secretary shall, not later than 120 days after
the date of enactment of this paragraph, by regulation modify
parts 812 and 813 of title 21, Code of Federal Regulations to
update the procedures and conditions under which a device
intended for human use may, upon application by the sponsor
of the device, be granted an exemption from the requirements
of this Act.
``(B) The regulation shall permit developmental changes in
a device (including manufacturing changes) in response to
information collected during an investigation without
requiring an additional approval of an application for an
investigational device exemption or the approval of a
supplement to such application, if the sponsor of the
investigation determines, based on credible information,
prior to making any such changes, that the changes--
``(i) do not affect the scientific soundness of an
investigational plan submitted under paragraph (3)(A) or the
rights, safety, or welfare of the human subjects involved in
the investigation; and
``(ii) do not constitute a significant change in design, or
a significant change in basic principles of operation, of the
device.''.
(b) Action on Application.--Section 515(d)(1)(B) (21 U.S.C.
360e(d)(1)(B)) is amended by adding at the end the following:
``(iii) The Secretary shall accept and review data and any
other information from investigations conducted under the
authority of regulations required by section 520(g), to make
a determination of whether there is a reasonable assurance of
safety and effectiveness of a device subject to a pending
application under this section if--
``(I) the data or information is derived from
investigations of an earlier version of the device, the
device has been modified during or after the investigations
(but prior to submission of an application under subsection
(c)) and such a modification of the device does not
constitute a significant change in the design or in the basic
principles of operation of the device that would invalidate
the data or information; or
``(II) the data or information relates to a device approved
under this section, is available for use under this Act, and
is relevant to the design and intended use of the device for
which the application is pending.''.
(c) Action on Supplements.--Section 515(d) (21 U.S.C.
360e(d)), as amended by section 302, is further amended by
adding at the end the following:
``(6)(A)(i) A supplemental application shall be required
for any change to a device subject to an approved application
under this subsection that affects safety or effectiveness,
unless such change is a modification in a manufacturing
procedure or method of
[[Page S9855]]
manufacturing and the holder of the approved application
submits a written notice to the Secretary that describes in
detail the change, summarizes the data or information
supporting the change, and informs the Secretary that the
change has been made under the requirements of section
520(f).
``(ii) The holder of an approved application who submits a
notice under clause (i) with respect to a manufacturing
change of a device may distribute the device 30 days after
the date on which the Secretary receives the notice, unless
the Secretary within such 30-day period notifies the holder
that the notice is not adequate and describes such further
information or action that is required for acceptance of such
change. If the Secretary notifies the holder that a premarket
approval supplement is required, the Secretary shall review
the supplement within 135 days after the receipt of the
supplement. The time used by the Secretary to review the
notice of the manufacturing change shall be deducted from the
135-day review period if the notice meets appropriate content
requirements for premarket approval supplements.
``(B)(i) Subject to clause (ii), in reviewing a supplement
to an approved application, for an incremental change to the
design of a device that affects safety or effectiveness, the
Secretary shall approve such supplement if--
``(I) nonclinical data demonstrate that the design
modification creates the intended additional capacity,
function, or performance of the device; and
``(II) clinical data from the approved application and any
supplement to the approved application provide a reasonable
assurance of safety and effectiveness for the changed device.
``(ii) The Secretary may require, when necessary,
additional clinical data to evaluate the design modification
of the device to provide a reasonable assurance of safety and
effectiveness.''.
SEC. 602. ENVIRONMENTAL IMPACT REVIEW.
Chapter VII (21 U.S.C. 371 et seq.), as amended by section
402, is further amended by adding at the end the following:
``SEC. 742. ENVIRONMENTAL IMPACT REVIEW.
``Notwithstanding any other provision of law, an
environmental impact statement prepared in accordance with
the regulations published in part 25 of title 21, Code of
Federal Regulations (as in effect on August 31, 1997) in
connection with an action carried out under (or a
recommendation or report relating to) this Act, shall be
considered to meet the requirements for a detailed statement
under section 102(2)(C) of the National Environmental Policy
Act of 1969 (42 U.S.C. 4332(2)(C)).''.
SEC. 603. EXEMPTION OF CERTAIN CLASSES OF DEVICES FROM
PREMARKET NOTIFICATION REQUIREMENT.
(a) Class I and Class II Devices.--Section 510(k) (21
U.S.C. 360(k)) is amended by striking ``intended for human
use'' and inserting ``intended for human use (except a device
that is classified into class I under section 513 or 520
unless the Secretary determines such device is intended for a
use that is of substantial importance in preventing
impairment of human health or such device presents a
potential unreasonable risk of illness or injury, or a device
that is classified into class II under section 513 or 520 and
is exempt from the requirements of this subsection under
subsection (l))''.
(b) Publication of Exemption.--Section 510 (21 U.S.C. 360)
is amended by inserting after subsection (k) the following:
``(l)(1) Not later than 30 days after the date of enactment
of this subsection, the Secretary shall publish in the
Federal Register a list of each type of class II device that
does not require a notification under subsection (k) to
provide reasonable assurance of safety and effectiveness.
Each type of class II device identified by the Secretary not
to require the notification shall be exempt from the
requirement to provide notification under subsection (k) as
of the date of the publication of the list in the Federal
Register.
``(2) Beginning on the date that is 1 day after the date of
the publication of a list under this subsection, the
Secretary may exempt a class II device from the notification
requirement of subsection (k), upon the Secretary's own
initiative or a petition of an interested person, if the
Secretary determines that such notification is not necessary
to assure the safety and effectiveness of the device. The
Secretary shall publish in the Federal Register notice of the
intent of the Secretary to exempt the device, or of the
petition, and provide a 30-day period for public comment.
Within 120 days after the issuance of the notice in the
Federal Register, the Secretary shall publish an order in the
Federal Register that sets forth the final determination of
the Secretary regarding the exemption of the device that was
the subject of the notice.''.
SEC. 604. EVALUATION OF AUTOMATIC CLASS III DESIGNATION.
Section 513(f) (21 U.S.C. 360c(f)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (B), by striking ``paragraph (2)'' and
inserting ``paragraph (3)''; and
(B) in the last sentence, by striking ``paragraph (2)'' and
inserting ``paragraph (2) or (3)'';
(2) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively; and
(3) by inserting after paragraph (1) the following:
``(2)(A) Any person who submits a report under section
510(k) for a type of device that has not been previously
classified under this Act, and that is classified into class
III under paragraph (1), may request, within 30 days after
receiving written notice of such a classification, the
Secretary to classify the device under the criteria set forth
in subparagraphs (A) through (C) subsection (a)(1). The
person may, in the request, recommend to the Secretary a
classification for the device. Any such request shall
describe the device and provide detailed information and
reasons for the recommended classification.
``(B)(i) Not later than 60 days after the date of the
submission of the request under subparagraph (A) for
classification of a device under the criteria set forth in
subparagraphs (A) through (C) of subsection (a)(1), the
Secretary shall by written order classify the device. Such
classification shall be the initial classification of the
device for purposes of paragraph (1) and any device
classified under this paragraph shall be a predicate device
for determining substantial equivalence under paragraph (1).
``(ii) A device that remains in class III under this
subparagraph shall be deemed to be adulterated within the
meaning of section 501(f)(1)(B) until approved under section
515 or exempted from such approval under section 520(g).
``(C) Within 30 days after the issuance of an order
classifying a device under this paragraph, the Secretary
shall publish a notice in the Federal Register announcing
such classification.''.
SEC. 605. SECRETARY'S DISCRETION TO TRACK DEVICES.
(a) Release of Information.--Section 519(e) (21 U.S.C.
360i(e)) is amended by adding at the end the following flush
sentence:
``Any patient receiving a device subject to tracking under
this section may refuse to release, or refuse permission to
release, the patient's name, address, social security number,
or other identifying information for the purpose of
tracking.''.
(b) Publication of Certain Devices.--Not later than 180
days after the date of enactment of this Act, the Secretary
of Health and Human Services shall develop and publish in the
Federal Register a list that identifies each type of device
subject to tracking under section 519(e)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360i(e)(1)). Each
device not identified by the Secretary of Health and Human
Services under this subsection or designated by the Secretary
under section 519(e)(2) shall be deemed to be exempt from the
mandatory tracking requirement under section 519 of such Act.
The Secretary of Health and Human Services shall have
authority to modify the list of devices exempted from the
mandatory tracking requirements.
SEC. 606. SECRETARY'S DISCRETION TO CONDUCT POSTMARKET
SURVEILLANCE.
(a) In General.--Section 522 (21 U.S.C. 360l) is amended by
striking ``Sec. 522.'' and all that follows through ``(2)
Discretionary surveillance.--The'' and inserting the
following:
``Sec. 522. (a) Discretionary Surveillance.--The''.
(b) Surveillance Approval.--Section 522(b) (21 U.S.C.
360l(b)) is amended to read as follows:
``(b) Surveillance Approval.--
``(1) In general.--Each manufacturer that receives notice
from the Secretary that the manufacturer is required to
conduct surveillance of a device under subsection (a) shall,
not later than 30 days after receiving the notice, submit for
the approval of the Secretary, a plan for the required
surveillance.
``(2) Determination.--Not later than 60 days after the
receipt of the plan, the Secretary shall determine if a
person proposed in the plan to conduct the surveillance has
sufficient qualifications and experience to conduct the
surveillance and if the plan will result in the collection of
useful data that can reveal unforeseen adverse events or
other information necessary to protect the public health and
to provide safety and effectiveness information for the
device.
``(3) Limitation on plan approval.--The Secretary may not
approve the plan until the plan has been reviewed by a
qualified scientific and technical review committee
established by the Secretary.''.
SEC. 607. REPORTING.
(a) Reports.--Section 519 (21 U.S.C. 360i) is amended--
(1) in subsection (a)--
(A) in the first sentence by striking ``make such reports,
and provide such information,'' and inserting ``and each such
manufacturer or importer shall make such reports, provide
such information, and submit such samples and components of
devices (as required by paragraph (10)),'';
(B) in paragraph (8), by striking ``; and'' and inserting a
semicolon; and
(C) by striking paragraph (9) and inserting the following:
``(9) shall require distributors to keep records and make
such records available to the Secretary upon request; and'';
(2) by striking subsection (d); and
(3) in subsection (f), by striking ``, importer, or
distributor'' each place it appears and inserting ``or
importer''.
(b) Registration.--Section 510(g) (21 U.S.C. 360(g)) is
amended--
(1) by redesignating paragraph (4) as paragraph (5);
(2) by inserting after paragraph (3), the following:
``(4) any distributor who acts as a wholesale distributor
of devices, and who does not
[[Page S9856]]
manufacture, repackage, process, or relabel a device; or'';
and
(3) by adding at the end the following flush sentence:
``In this subsection, the term `wholesale distributor' means
any person who distributes a device from the original place
of manufacture to the person who makes the final delivery or
sale of the device to the ultimate consumer or user.''.
SEC. 608. PILOT AND SMALL-SCALE MANUFACTURE.
(a) New Drugs.--Section 505(c) (21 U.S.C. 355(c)) is
amended by adding at the end the following:
``(4) A new drug manufactured in a pilot or other small
facility may be used to demonstrate the safety
and effectiveness of the new drug and to obtain approval
of the new drug prior to scaling up to a larger facility,
unless the Secretary determines that a full scale
production facility is necessary to ensure the safety or
effectiveness of the new drug.''.
(b) New Animal Drugs.--Section 512(c) (21 U.S.C. 360b(c))
is amended by adding at the end the following:
``(4) A new animal drug manufactured in a pilot or other
small facility may be used to demonstrate the safety and
effectiveness of the new drug and to obtain approval of the
new drug prior to scaling up to a larger facility, unless the
Secretary determines that a full scale production facility is
necessary to ensure the safety or effectiveness of the new
drug.''.
SEC. 609. REQUIREMENTS FOR RADIOPHARMACEUTICALS.
(a) Requirements.--
(1) Regulations.--
(A) Proposed regulations.--Not later than 180 days after
the date of enactment of this Act, the Secretary of Health
and Human Services, after consultation with patient advocacy
groups, associations, physicians licensed to use
radiopharmaceuticals, and the regulated industry, shall issue
proposed regulations governing the approval of
radiopharmaceuticals designed for diagnosis and monitoring of
diseases and conditions. The regulations shall provide that
the determination of the safety and effectiveness of such a
radiopharmaceutical under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the
Public Health Service Act (42 U.S.C. 262) shall include (but
not be limited to) consideration of the proposed use of the
radiopharmaceutical in the practice of medicine, the
pharmacological and toxicological activity of the
radiopharmaceutical (including any carrier or ligand
component of the radiopharmaceutical), and the estimated
absorbed radiation dose of the radiopharmaceutical.
(B) Final regulations.--Not later than 18 months after the
date of enactment of this Act, the Secretary shall promulgate
final regulations governing the approval of the
radiopharmaceuticals.
(2) Special rule.--In the case of a radiopharmaceutical
intended to be used for diagnostic or monitoring purposes,
the indications for which such radiopharmaceutical is
approved for marketing may, in appropriate cases, refer to
manifestations of disease (such as biochemical,
physiological, anatomic, or pathological processes) common
to, or present in, 1 or more disease states.
(b) Definition.--In this section, the term
``radiopharmaceutical'' means--
(1) an article--
(A) that is intended for use in the diagnosis or monitoring
of a disease or a manifestation of a disease in humans; and
(B) that exhibits spontaneous disintegration of unstable
nuclei with the emission of nuclear particles or photons; or
(2) any nonradioactive reagent kit or nuclide generator
that is intended to be used in the preparation of any such
article.
SEC. 610. MODERNIZATION OF REGULATION OF BIOLOGICAL PRODUCTS.
(a) Licenses.--
(1) In general.--Section 351(a) of the Public Health
Service (42 U.S.C. 262(a)) is amended to read as follows:
``(a)(1) Except as provided in paragraph (4), no person
shall introduce or deliver for introduction into interstate
commerce any biological product unless--
``(A) a biologics license is in effect for the biological
product; and
``(B) each package of the biological product is plainly
marked with--
``(i) the proper name of the biological product contained
in the package;
``(ii) the name, address, and applicable license number of
the manufacturer of the biological product; and
``(iii) the expiration date of the biological product.
``(2)(A) The Secretary shall establish, by regulation,
requirements for the approval, suspension, and revocation of
biologics licenses.
``(B) The Secretary shall approve a biologics license
application on the basis of a demonstration that--
``(i) the biological product that is the subject of the
application is safe, pure, and potent; and
``(ii) the facility in which the biological product is
manufactured, processed, packed, or held meets standards
designed to assure that the biological product continues to
be safe, pure, and potent.
``(3) A biologics license application shall be approved
only if the applicant (or other appropriate person) consents
to the inspection of the facility that is the subject of the
application, in accordance with subsection (c).
``(4) The Secretary shall prescribe requirements under
which a biological product undergoing investigation shall be
exempt from the requirements of paragraph (1).''.
(2) Elimination of existing license requirement.--Section
351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is
amended--
(A) by striking ``(d)(1)'' and all that follows through
``of this section.'';
(B) in paragraph (2)--
(i) by striking ``(2)(A) Upon'' and inserting ``(d)(1)
Upon;'' and
(ii) by redesignating subparagraph (B) as paragraph (2);
and
(C) in paragraph (2) (as so redesignated by subparagraph
(B)(ii))--
(i) by striking ``subparagraph (A)'' and inserting
``paragraph (1)''; and
(ii) by striking ``this subparagraph'' each place it
appears and inserting ``this paragraph''.
(b) Labeling.--Section 351(b) of the Public Health Service
Act (42 U.S.C. 262(b)) is amended to read as follows:
``(b) No person shall falsely label or mark any package or
container of any biological product or alter any label or
mark on the package or container of the biological product so
as to falsify the label or mark.''.
(c) Inspection.--Section 351(c) of the Public Health
Service Act (42 U.S.C. 262(c)) is amended by striking
``virus, serum,'' and all that follows and inserting
``biological product.''.
(d) Definition; Application.--Section 351 of the Public
Health Service Act (42 U.S.C. 262) is amended by adding at
the end the following:
``(i) In this section, the term `biological product' means
a virus, therapeutic serum, toxin, antitoxin, vaccine, blood,
blood component or derivative, allergenic product, or
analogous product, or arsphenamine or derivative of
arsphenamine (or any other trivalent organic arsenic
compound), applicable to the prevention, treatment, or cure
of a disease or condition of human beings.''.
(e) Conforming Amendment.--Section 503(g)(4) (21 U.S.C.
353(g)(4)) is amended--
(1) in subparagraph (A)--
(A) by striking ``section 351(a)'' and inserting ``section
351(i)''; and
(B) by striking ``262(a)'' and inserting ``262(i)''; and
(2) in subparagraph (B)(iii), by striking ``product or
establishment license under subsection (a) or (d)'' and
inserting ``biologics license application under subsection
(a)''.
(f) Special Rule.--The Secretary of Health and Human
Services shall take measures to minimize differences in the
review and approval of products required to have approved
biologics license applications under section 351 of the
Public Health Service Act (42 U.S.C. 262) and products
required to have approved full new drug applications under
section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(b)(1)).
SEC. 611. APPROVAL OF SUPPLEMENTAL APPLICATIONS FOR APPROVED
PRODUCTS.
(a) Performance Standards.--Not later than 180 days after
the date of enactment of this section, the Secretary of
Health and Human Services shall publish in the Federal
Register performance standards for the prompt review of
supplemental applications submitted for approved articles
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321
et seq.).
(b) Guidance to Industry.--Not later than 180 days after
the date of enactment of this section, the Secretary of
Health and Human Services shall issue final guidances to
clarify the requirements for, and facilitate the submission
of data to support, the approval of supplemental applications
for the approved articles described in subsection (a). The
guidances shall--
(1) clarify circumstances in which published matter may be
the basis for approval of a supplemental application;
(2) specify data requirements that will avoid duplication
of previously submitted data by recognizing the availability
of data previously submitted in support of an original
application; and
(3) define supplemental applications that are eligible for
priority review.
(c) Responsibilities of Centers.--The Secretary of Health
and Human Services shall designate an individual in each
center within the Food and Drug Administration (except the
Center for Food Safety and Applied Nutrition) to be
responsible for--
(1) encouraging the prompt review of supplemental
applications for approved articles; and
(2) working with sponsors to facilitate the development and
submission of data to support supplemental applications.
(d) Collaboration.--The Secretary of Health and Human
Services shall implement programs and policies that will
foster collaboration between the Food and Drug
Administration, the National Institutes of Health,
professional medical and scientific societies, and other
persons, to identify published and unpublished studies that
may support a supplemental application, and to encourage
sponsors to make supplemental applications or conduct further
research in support of a supplemental application based, in
whole or in part, on such studies.
SEC. 612. HEALTH CARE ECONOMIC INFORMATION.
(a) In General.--Section 502(a) (21 U.S.C. 352(a)) is
amended by adding at the end the
[[Page S9857]]
following: ``Health care economic information provided to a
formulary committee, or other similar entity, in the course
of the committee or the entity carrying out its
responsibilities for the selection of drugs for managed care
or other similar organizations, shall not be considered to be
false or misleading if the health care economic information
directly relates to an indication approved under section 505
or 507 or section 351(a) of the Public Health Service Act (42
U.S.C. 262(a)) for such drug and is based on competent and
reliable scientific evidence. The requirements set forth in
section 505(a), 507, or section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) shall not apply to health care
economic information provided to such a committee or entity
in accordance with this paragraph. Information that is
relevant to the substantiation of the health care economic
information presented pursuant to this paragraph shall be
made available to the Secretary upon request. In this
paragraph, the term `health care economic information' means
any analysis that identifies, measures, or compares the
economic consequences, including the costs of the represented
health outcomes, of the use of a drug to the use of another
drug, to another health care intervention, or to no
intervention.''.
(b) Study and Report.--The Comptroller General of the
United States shall conduct a study of the implementation of
the provisions added by the amendment made by subsection (a).
Not later than 4 years and 6 months after the date of
enactment of this Act, the Comptroller General of the United
States shall prepare and submit to Congress a report
containing the findings of the study.
SEC. 613. EXPEDITING STUDY AND APPROVAL OF FAST TRACK DRUGS.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.), as
amended by section 102, is further amended by adding at the
end the following:
``Subchapter E--Fast Track Drugs and Reports of Post-Market Approval
Studies
``SEC. 561. FAST TRACK DRUGS.
``(a) Designation of Drug as a Fast Track Drug.--
``(1) In general.--The Secretary shall facilitate
development, and expedite review and approval of new drugs
and biological products that are intended for the treatment
of serious or life-threatening conditions and that
demonstrate the potential to address unmet medical needs for
such conditions. In this Act, such products shall be known as
`fast track drugs'.
``(2) Request for designation.--The sponsor of a drug
(including a biological product) may request the Secretary to
designate the drug as a fast track drug. A request for the
designation may be made concurrently with, or at any time
after, submission of an application for the investigation of
the drug under section 505(i) or section 351(a)(4) of the
Public Health Service Act.
``(3) Designation.--Within 30 calendar days after the
receipt of a request under paragraph (2), the Secretary shall
determine whether the drug that is the subject of the request
meets the criteria described in paragraph (1). If the
Secretary finds that the drug meets the criteria, the
Secretary shall designate the drug as a fast track drug and
shall take such actions as are appropriate to expedite the
development and review of the drug.
``(b) Approval of Application for a Fast Track Drug.--
``(1) In general.--The Secretary may approve an application
for approval of a fast track drug under section 505(b) or
section 351 of the Public Health Service Act (21 U.S.C. 262)
upon a determination that the drug has an effect on a
surrogate endpoint that is reasonably likely to predict
clinical benefit.
``(2) Limitation.--Approval of a fast track drug under this
subsection may be subject to the requirements--
``(A) that the sponsor conduct appropriate post-approval
studies to validate the surrogate endpoint or otherwise
confirm the clinical benefit of the drug; and
``(B) that the sponsor submit copies of all promotional
materials related to the fast track drug during the
preapproval review period and following approval, at least 30
days prior to dissemination of the materials for such period
of time as the Secretary deems appropriate.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a fast track drug using expedited
procedures (as prescribed by the Secretary in regulations)
including a procedure that provides an opportunity for an
informal hearing, if--
``(A) the sponsor fails to conduct any required post-
approval study of the fast track drug with due diligence;
``(B) a post-approval study of the fast track drug fails to
verify clinical benefit of the fast track drug;
``(C) other evidence demonstrates that the fast track drug
is not safe or effective under conditions of use of the drug;
or
``(D) the sponsor disseminates false or misleading
promotional materials with respect to the fast track drug.
``(c) Review of Incomplete Applications for Approval of a
Fast Track Drug.--
``(1) In general.--If preliminary evaluation by the
Secretary of clinical efficacy data for a fast track drug
under investigation shows evidence of effectiveness, the
Secretary shall evaluate for filing, and may commence review
of, portions of an application for the approval of the drug
if the applicant provides a schedule for submission of
information necessary to make the application complete and
any fee that may be required under section 736.
``(2) Exception.--Any time period for review of human drug
applications that has been agreed to by the Secretary and
that has been set forth in goals identified in letters of the
Secretary (relating to the use of fees collected under
section 736 to expedite the drug development process and the
review of human drug applications) shall not apply to an
application submitted under paragraph (1) until the date on
which the application is complete.
``(d) Awareness Efforts.--The Secretary shall--
``(1) develop and widely disseminate to physicians, patient
organizations, pharmaceutical and biotechnology companies,
and other appropriate persons a comprehensive description of
the provisions applicable to fast track drugs established
under this section; and
``(2) establish an ongoing program to encourage the
development of surrogate endpoints that are reasonably likely
to predict clinical benefit for serious or life-threatening
conditions for which there exist significant unmet medical
needs.''.
(b) Guidance.--Within 1 year after the date of enactment of
this Act, the Secretary of Health and Human Services shall
issue guidance for fast track drugs that describes the
policies and procedures that pertain to section 561 of the
Federal Food, Drug, and Cosmetic Act.
SEC. 614. MANUFACTURING CHANGES FOR DRUGS AND BIOLOGICS.
(a) In General.--Chapter VII (21 U.S.C. 371 et seq.), as
amended by section 602, is further amended by adding at the
end the following:
``Subchapter E--Manufacturing Changes
``SEC. 751. MANUFACTURING CHANGES.
``(a) In General.--A change in the manufacture of a new
drug, including a biological product, or a new animal drug
may be made in accordance with this section.
``(b) Changes.--
``(1) Validation.--Before distributing a drug made after a
change in the manufacture of the drug from the manufacturing
process established in the approved new drug application
under section 505, the approved new animal drug application
under section 512, or the license application under section
351 of the Public Health Service Act, the applicant shall
validate the effect of the change on the identity, strength,
quality, purity, and potency of the drug as the identity,
strength, quality, purity, and potency may relate to the
safety or effectiveness of the drug.
``(2) Reports.--The applicant shall report the change
described in paragraph (1) to the Secretary and may
distribute a drug made after the change as follows:
``(A) Major manufacturing changes.--
``(i) In general.--Major manufacturing changes, which are
of a type determined by the Secretary to have substantial
potential to adversely affect the identity, strength,
quality, purity, or potency of the drug as the identity,
strength, quality, purity, and potency may relate to the
safety or effectiveness of a drug, shall be submitted to the
Secretary in a supplemental application and drugs made after
such changes may not be distributed until the Secretary
approves the supplemental application.
``(ii) Definition.--In this subparagraph, the term `major
manufacturing changes' means--
``(I) changes in the qualitative or quantitative
formulation of a drug or the specifications in the approved
marketing application for the drug (unless exempted by the
Secretary from the requirements of this subparagraph);
``(II) changes that the Secretary determines by regulation
or issuance of guidance require completion of an appropriate
human study demonstrating equivalence of the drug to the drug
manufactured before such changes; and
``(III) other changes that the Secretary determines by
regulation or issuance of guidance have a substantial
potential to adversely affect the safety or effectiveness of
the drug.
``(B) Other manufacturing changes.--
``(i) In general.--As determined by the Secretary,
manufacturing changes other than major manufacturing changes
shall--
``(I) be made at any time and reported annually to the
Secretary, with supporting data; or
``(II) be reported to the Secretary in a supplemental
application.
``(ii) Distribution of the drug.--In the case of changes
reported in accordance with clause (i)(II)--
``(I) the applicant may distribute the drug 30 days after
the Secretary receives the supplemental application unless
the Secretary notifies the applicant within such 30-day
period that prior approval of such supplemental application
is required;
``(II) the Secretary shall approve or disapprove each such
supplemental application; and
``(III) the Secretary may determine types of manufacturing
changes after which distribution of a drug may commence at
the time of submission of such supplemental application.''.
(b) Existing Law.--The requirements of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) and the Public
Health Service Act (42 U.S.C. 201 et seq.) that are in effect
on the date of enactment of this Act with respect to
manufacturing changes shall remain in effect--
(1) for a period of 24 months after the date of enactment
of this Act; or
[[Page S9858]]
(2) until the effective date of regulations promulgated by
the Secretary of Health and Human Services implementing
section 751 of the Federal Food, Drug, and Cosmetic Act,
whichever is sooner.
SEC. 615. DATA REQUIREMENTS FOR DRUGS AND BIOLOGICS.
Within 12 months after the date of enactment of this Act,
the Secretary of the Health and Human Services, acting
through the Commissioner of Food and Drugs, shall issue
guidance that describes when abbreviated study reports may be
submitted, in lieu of full reports, with a new drug
application under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) and with a biologics license
application under section 351 of the Public Health Service
Act (42 U.S.C. 262) for certain types of studies. Such
guidance shall describe the kinds of studies for which
abbreviated reports are appropriate and the appropriate
abbreviated report formats.
SEC. 616. FOOD CONTACT SUBSTANCES.
(a) Food Contact Substances.--Section 409(a) (21 U.S.C.
348(a)) is amended--
(1) in paragraph (1)--
(A) by striking ``subsection (i)'' and inserting
``subsection (j)''; and
(B) by striking at the end ``or'';
(2) by striking the period at the end of paragraph (2) and
inserting ``; or'';
(3) by inserting after paragraph (2) the following:
``(3) in the case of a food additive as defined in this Act
that is a food contact substance, there is--
``(A) in effect, and such substance and the use of such
substance are in conformity with, a regulation issued under
this section prescribing the conditions under which such
additive may be safely used; or
``(B) a notification submitted under subsection (h) that is
effective.''; and
(4) by striking the matter following paragraph (3) (as
added by paragraph (2)) and inserting the following flush
sentence:
``While such a regulation relating to a food additive, or
such a notification under subsection (h) relating to a food
additive that is a food contact substance, is in effect, and
has not been revoked pursuant to subsection (i), a food shall
not, by reason of bearing or containing such a food additive
in accordance with the regulation or notification, be
considered adulterated under section 402(a)(1).''.
(b) Notification for Food Contact Substances.--Section 409
(21 U.S.C. 348), as amended by subsection (a), is further
amended--
(1) by redesignating subsections (h) and (i), as
subsections (i) and (j), respectively;
(2) by inserting after subsection (g) the following:
``Notification Relating to a Food Contact Substance
``(h)(1) Subject to such regulations as may be promulgated
under paragraph (3), a manufacturer or supplier of a food
contact substance may, at least 120 days prior to the
introduction or delivery for introduction into interstate
commerce of the food contact substance, notify the Secretary
of the identity and intended use of the food contact
substance, and of the determination of the manufacturer or
supplier that the intended use of such food contact substance
is safe under the standard described in subsection (c)(3)(A).
The notification shall contain the information that forms the
basis of the determination, the fee required under paragraph
(5), and all information required to be submitted by
regulations promulgated by the Secretary.
``(2)(A) A notification submitted under paragraph (1) shall
become effective 120 days after the date of receipt by the
Secretary and the food contact substance may be introduced or
delivered for introduction into interstate commerce, unless
the Secretary makes a determination within the 120-day period
that, based on the data and information before the Secretary,
such use of the food contact substance has not been shown to
be safe under the standard described in subsection (c)(3)(A),
and informs the manufacturer or supplier of such
determination.
``(B) A decision by the Secretary to object to a
notification shall constitute final agency action subject to
judicial review.
``(C) In this paragraph, the term `food contact substance'
means the substance that is the subject of a notification
submitted under paragraph (1), and does not include a similar
or identical substance manufactured or prepared by a person
other than the manufacturer identified in the notification.
``(3)(A) The process in this subsection shall be utilized
for authorizing the marketing of a food contact substance
except where the Secretary determines that submission and
review of a petition under subsection (b) is necessary to
provide adequate assurance of safety, or where the Secretary
and any manufacturer or supplier agree that such manufacturer
or supplier may submit a petition under subsection (b).
``(B) The Secretary is authorized to promulgate regulations
to identify the circumstances in which a petition shall be
filed under subsection (b), and shall consider criteria such
as the probable consumption of such food contact substance
and potential toxicity of the food contact substance in
determining the circumstances in which a petition shall be
filed under subsection (b).
``(4) The Secretary shall keep confidential any information
provided in a notification under paragraph (1) for 120 days
after receipt by the Secretary of the notification. After the
expiration of such 120 days, the information shall be
available to any interested party except for any matter in
the notification that is a trade secret or confidential
commercial information.
``(5)(A) Each person that submits a notification regarding
a food contact substance under this section shall be subject
to the payment of a reasonable fee. The fee shall be based on
the resources required to process the notification including
reasonable administrative costs for such processing.
``(B) The Secretary shall conduct a study of the costs of
administering the notification program established under this
section and, on the basis of the results of such study,
shall, within 18 months after the date of enactment of the
Food and Drug Administration Modernization and Accountability
Act of 1997, promulgate regulations establishing the fee
required by subparagraph (A).
``(C) A notification submitted without the appropriate fee
is not complete and shall not become effective for the
purposes of subsection (a)(3) until the appropriate fee is
paid.
``(D) Fees collected pursuant to this subsection--
``(i) shall not be deposited as an offsetting collection to
the appropriations for the Department of Health and Human
Services;
``(ii) shall be credited to the appropriate account of the
Food and Drug Administration; and
``(iii) shall be available in accordance with appropriation
Acts until expended, without fiscal year limitation.
``(6) In this section, the term `food contact substance'
means any substance intended for use as a component of
materials used in manufacturing, packing, packaging,
transporting, or holding food if such use is not intended to
have any technical effect in such food.'';
(3) in subsection (i), as so redesignated by paragraph (1),
by adding at the end the following: ``The Secretary shall by
regulation prescribe the procedure by which the Secretary may
deem a notification under subsection (h) to no longer be
effective.''; and
(4) in subsection (j), as so redesignated by paragraph (1),
by striking ``subsections (b) to (h)'' and inserting
``subsections (b) to (i)''.
(c) Effective Date.--Notifications under section 409(h) of
the Federal Food, Drug, and Cosmetic Act, as added by
subsection (b), may be submitted beginning 18 months after
the date of enactment of this Act.
SEC. 617. HEALTH CLAIMS FOR FOOD PRODUCTS.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amended by
adding at the end the following:
``(C) Notwithstanding the provisions of clauses (A)(i) and
(B), a claim of the type described in subparagraph (1)(B)
that is not authorized by the Secretary in a regulation
promulgated in accordance with clause (B) shall be authorized
and may be made if--
``(i) an authoritative scientific body of the Federal
Government with official responsibility for public health
protection or research directly relating to human nutrition
(such as the National Institutes of Health or the Centers for
Disease Control and Prevention), the National Academy of
Sciences, or a subdivision of the scientific body or the
National Academy of Sciences, has published an authoritative
statement, which is currently in effect, about the
relationship between a nutrient and a disease or health-
related condition to which the claim refers;
``(ii) a person has submitted to the Secretary at least 120
days before the first introduction of a food into interstate
commerce a notice of the claim, including a concise
description of the basis upon which such person relied for
determining that the requirements of subclause (i) have been
satisfied;
``(iii) the claim and the food for which the claim is made
are in compliance with clause (A)(ii), and are otherwise in
compliance with paragraph (a) and section 201(n); and
``(iv) the claim is stated in a manner so that the claim is
an accurate representation of the authoritative statement
referred to in subclause (i) and so that the claim enables
the public to comprehend the information provided in the
claim and to understand the relative significance of such
information in the context of a total daily diet.
For purposes of this paragraph, a statement shall be regarded
as an authoritative statement of such a scientific body
described in subclause (i) only if the statement is published
by the scientific body and shall not include a statement of
an employee of the scientific body made in the individual
capacity of the employee.
``(D) A claim submitted under the requirements of clause
(C), may be made until--
``(i) such time as the Secretary issues an interim final
regulation--
``(I) under the standard in clause (B)(i), prohibiting or
modifying the claim; or
``(II) finding that the requirements of clause (C) have not
been met; or
``(ii) a district court of the United States in an
enforcement proceeding under chapter III has determined that
the requirements of clause (C) have not been met.
Where the Secretary issues a regulation under subclause (i),
good cause shall be deemed to exist for the purposes of
subsections (b)(B) and (d)(3) of section 553 of title 5,
United States Code. The Secretary shall solicit comments in
response to a regulation promulgated under subclause (i) and
shall publish a response to such comments.''.
SEC. 618. PEDIATRIC STUDIES MARKETING EXCLUSIVITY.
(a) General Authority.--Chapter V of the Federal Food,
Drug, and Cosmetic Act (21
[[Page S9859]]
U.S.C. 351 et seq.) is amended by inserting after section 505
the following:
``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.
``(a) Market Exclusivity for New Drugs.--If, prior to
approval of an application that is submitted under section
505(b)(1), the Secretary determines that information relating
to the use of a drug in the pediatric population may produce
health benefits in that population, the Secretary makes a
written request for pediatric studies (which may include a
timeframe for completing such studies), and such studies are
completed within any such timeframe and the reports thereof
submitted in accordance with subsection (d)(2) or completed
within any such timeframe and the reports thereof are
accepted in accordance with subsection (d)(3)--
``(1)(A) the period during which an application may not be
submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii)
of section 505 shall be five years and six months rather than
five years, and the references in subsections (c)(3)(D)(ii)
and (j)(4)(D)(ii) of section 505 to four years, to forty-
eight months, and to seven and one-half years shall be deemed
to be four and one-half years, fifty-four months, and eight
years, respectively; or
``(B) the period of market exclusivity under subsections
(c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of
section 505 shall be three years and six months rather than
three years; and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505 and for which pediatric
studies were submitted prior to the expiration of the patent
(including any patent extensions); or
``(ii) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved
under subsection (c)(3) or (j)(4)(B) of section 505 shall be
extended by a period of six months after the date the patent
expires (including any patent extensions); or
``(B) if the drug is the subject of a listed
patent for which a certification has been submitted
under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of
section 505, and in the patent infringement litigation
resulting from the certification the court determines that
the patent is valid and would be infringed, the period during
which an application may not be approved under subsection
(c)(3) or (j)(4)(B) of section 505 shall be extended by a
period of six months after the date the patent expires
(including any patent extensions).
``(b) Secretary To Develop List of Drugs for Which
Additional Pediatric Information May Be Beneficial.--Not
later than 180 days after the date of enactment of this
section, the Secretary, after consultation with experts in
pediatric research (such as the American Academy of
Pediatrics, the Pediatric Pharmacology Research Unit Network,
and the United States Pharmacopoeia) shall develop,
prioritize, and publish an initial list of approved drugs for
which additional pediatric information may produce health
benefits in the pediatric population. The Secretary shall
annually update the list.
``(c) Market Exclusivity for Already-Marketed Drugs.--If
the Secretary makes a written request for pediatric studies
(which may include a timeframe for completing such studies)
concerning a drug identified in the list described in
subsection (b) to the holder of an approved application under
section 505(b)(1) for the drug, the holder agrees to the
request, and the studies are completed within any such
timeframe and the reports thereof submitted in accordance
with subsection (d)(2) or completed within any such timeframe
and the reports thereof accepted in accordance with
subsection (d)(3)--
``(1)(A) the period during which an application may not be
submitted under subsections (c)(3)(D)(ii) and (j)(4)(D)(ii)
of section 505 shall be five years and six months rather than
five years, and the references in subsections (c)(3)(D)(ii)
and (j)(4)(D)(ii) of section 505 to four years, to forty-
eight months, and to seven and one-half years shall be deemed
to be four and one-half years, fifty-four months, and eight
years, respectively; or
``(B) the period of market exclusivity under subsections
(c)(3)(D) (iii) and (iv) and (j)(4)(D) (iii) and (iv) of
section 505 shall be three years and six months rather than
three years; and
``(2)(A) if the drug is the subject of--
``(i) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(ii) or
(j)(2)(A)(vii)(II) of section 505 and for which pediatric
studies were submitted prior to the expiration of the patent
(including any patent extensions); or
``(ii) a listed patent for which a certification has been
submitted under subsection (b)(2)(A)(iii) or
(j)(2)(A)(vii)(III) of section 505,
the period during which an application may not be approved
under subsection (c)(3) or (j)(4)(B) of section 505 shall be
extended by a period of six months after the date the patent
expires (including any patent extensions); or
``(B) if the drug is the subject of a listed
patent for which a certification has been
submitted under subsection (b)(2)(A)(iv) or
(j)(2)(A)(vii)(IV) of section 505, and in the patent
infringement litigation resulting from the certification the
court determines that the patent is valid and would be
infringed, the period during which an application may not be
approved under subsection (c)(3) or (j)(4)(B) of section 505
shall be extended by a period of six months after the date
the patent expires (including any patent extensions).
``(d) Conduct of Pediatric Studies.--
``(1) Agreement for studies.--The Secretary may, pursuant
to a written request for studies, after consultation with--
``(A) the sponsor of an application for an investigational
new drug under section 505(i);
``(B) the sponsor of an application for a drug under
section 505(b)(1); or
``(C) the holder of an approved application for a drug
under section 505(b)(1),
agree with the sponsor or holder for the conduct of pediatric
studies for such drug.
``(2) Written protocols to meet the studies requirement.--
If the sponsor or holder and the Secretary agree upon written
protocols for the studies, the studies requirement of
subsection (a) or (c) is satisfied upon the completion of the
studies and submission of the reports thereof in accordance
with the original written request and the written agreement
referred to in paragraph (1). Not later than 60 days after
the submission of the report of the studies, the Secretary
shall determine if such studies were or were not conducted in
accordance with the original written request and the written
agreement and reported in accordance with the requirements of
the Secretary for filing and so notify the sponsor or holder.
``(3) Other methods to meet the studies requirement.--If
the sponsor or holder and the Secretary have not agreed in
writing on the protocols for the studies, the studies
requirement of subsection (a) or (c) is satisfied when such
studies have been completed and the reports accepted by the
Secretary. Not later than 90 days after the submission of the
reports of the studies, the Secretary shall accept or reject
such reports and so notify the sponsor or holder. The
Secretary's only responsibility in accepting or rejecting the
reports shall be to determine, within the 90 days, whether
the studies fairly respond to the written request, whether
such studies have been conducted in accordance with commonly
accepted scientific principles and protocols, and whether
such studies have been reported in accordance with the
requirements of the Secretary for filing.
``(e) Delay of Effective Date for Certain Applications;
Period of Market Exclusivity.--If the Secretary determines
that the acceptance or approval of an application under
subsection (b)(2) or (j) of section 505 for a drug may occur
after submission of reports of pediatric studies under this
section, which were submitted prior to the expiration of the
patent (including any patent extension) or market exclusivity
protection, but before the Secretary has determined whether
the requirements of subsection (d) have been satisfied, the
Secretary shall delay the acceptance or approval under
subsection (b)(2) or (j), respectively, of section 505 until
the determination under subsection (d) is made, but such
delay shall not exceed 90 days. In the event that
requirements of this section are satisfied, the applicable
period of market exclusivity referred to in subsection (a) or
(c) shall be deemed to have been running during the period of
delay.
``(f) Notice of Determinations on Studies Requirement.--The
Secretary shall publish a notice of any determination that
the requirements of subsection (d) have been met and that
submissions and approvals under subsection (b)(2) or (j) of
section 505 for a drug will be subject to the provisions of
this section.
``(g) Limitation.--The holder of an approved application
for a new drug that has already received six months of market
exclusivity under subsection (a) or (c) may, if otherwise
eligible, obtain six months of market exclusivity under
subsection (c)(1)(B) for a supplemental application, except
that the holder is not eligible for exclusivity under
subsection (c)(2).
``(h) Study and Report.--The Secretary shall conduct a
study and report to Congress not later than January 1, 2003
based on the experience under the program. The study and
report shall examine all relevant issues, including--
``(1) the effectiveness of the program in improving
information about important pediatric uses for approved
drugs;
``(2) the adequacy of the incentive provided under this
section;
``(3) the economic impact of the program; and
``(4) any suggestions for modification that the Secretary
deems appropriate.
``(i) Termination of Market Exclusivity Extension Authority
for New Drugs.--Except as provided in section 618(b) of the
Food and Drug Administration Modernization and Accountability
Act of 1997, no period of market exclusivity shall be
extended under subsection (a) for a drug if--
``(1) the extension would be based on studies commenced
after January 1, 2004; and
``(2) the application submitted for the drug under section
505(b)(1) was not approved by January 1, 2004.
``(j) Definitions.--In this section, the term `pediatric
studies' or `studies' means at least 1 clinical investigation
(that, at the Secretary's discretion, may include
pharmacokinetic studies) in pediatric age-groups in which a
drug is anticipated to be used.''.
(b) Market Exclusivity Under Other Authority.--
[[Page S9860]]
(1) Through calendar year 2003.--
(A) Determination.--If the Secretary requests or requires
pediatric studies, prior to January 1, 2004, under Federal
law other than section 505A of the Federal Food, Drug, and
Cosmetic Act (as added by subsection (a)), from the sponsor
of an application, or the holder of an approved application,
for a drug under section 505(b) of such Act (21 U.S.C.
355(b)), the Secretary shall determine whether the studies
meet the completeness, timeliness, and other submission
requirements of the Federal law involved.
(B) Market exclusivity.--If the Secretary determines that
the studies meet the requirements involved, the Secretary
shall ensure that the period of market exclusivity for the
drug involved is extended for 6 months in accordance with the
requirements of subsection (a), (c), (e), and (g) (as
appropriate) of section 505A of such Act (as in effect on the
date of enactment of this Act.).
(2) Calendar year 2004 and subsequent years.--
(A) New drugs.--Effective January 1, 2004, if the Secretary
requests or requires pediatric studies, under Federal law
other than section 505A of the Federal Food, Drug, and
Cosmetic Act, from the sponsor of an application for a drug
under section 505(b) of such Act, nothing in such law shall
be construed to permit or require the Secretary to ensure
that the period of market exclusivity for the drug is
extended.
(B) Already marketed drugs.--
(i) Determination.--Effective January 1, 2004, if the
Secretary requests or requires pediatric studies, under
Federal law other than section 505A of the Federal Food,
Drug, and Cosmetic Act (as added by subsection (a)), from the
holder of an approved application for a drug under section
505(b) of such Act, the Secretary shall determine whether the
studies meet the completeness, timeliness, and other
submission requirements of the Federal law involved.
(ii) Market exclusivity.--If the Secretary determines that
the studies meet the requirements involved, the Secretary
shall ensure that the period of market exclusivity for the
drug involved is extended for 6 months in accordance with the
requirements of subsection (a), (c), (e), and (g) (as
appropriate) of section 505A of such Act (as in effect on the
date of enactment of this Act.).
(3) Definitions.--In this subsection:
(A) Drug.--The term ``drug'' has the meaning given the term
in section 201 of such Act.
(B) Pediatric studies.--The term ``pediatric studies'' has
the meaning given the term in section 505A of such Act.
(C) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
SEC. 619. POSITRON EMISSION TOMOGRAPHY.
(a) Regulation of Compounded Positron Emission Tomography
Drugs Under the Federal Food, Drug, and Cosmetic Act.--
(1) Definition.--Section 201 (21 U.S.C. 321) is amended by
adding at the end the following:
``(ii) The term `compounded positron emission tomography
drug'--
``(1) means a drug that--
``(A) exhibits spontaneous disintegration of unstable
nuclei by the emission of positrons and is used for the
purpose of providing dual photon positron emission
tomographic diagnostic images; and
``(B) has been compounded by or on the order of a
practitioner who is licensed by a State to compound or order
compounding for a drug described in subparagraph (A), and is
compounded in accordance with that State's law, for a patient
or for research, teaching, or quality control; and
``(2) includes any nonradioactive reagent, reagent kit,
ingredient, nuclide generator, accelerator, target material,
electronic synthesizer, or other apparatus or computer
program to be used in the preparation of such a drug.''.
(b) Adulteration.--
(1) In general.--Section 501(a)(2) (21 U.S.C. 351(a)(2)) is
amended by striking ``; or (3)'' and inserting the following:
``; or (C) if it is a compounded positron emission tomography
drug and the methods used in, or the facilities and controls
used for, its compounding, processing, packing, or holding do
not conform to or are not operated or administered in
conformity with the positron emission tomography compounding
standards and the official monographs of the United States
Pharmacopeia to assure that such drug meets the requirements
of this Act as to safety and has the identity and strength,
and meets the quality and purity characteristics, that it
purports or is represented to possess; or (3)''.
(2) Sunset.--Section 501(a)(2)(C) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not
apply 4 years after the date of enactment of this Act or 2
years after the date or which the Secretary of Health and
Human Services establishes the requirements described in
subsection (c)(1)(B), whichever is later.
(c) Requirements for Review of Approval Procedures and
Current Good Manufacturing Practices for Positron Emission
Tomography.--
(1) Procedures and requirements.--
(A) In general.--In order to take account of the special
characteristics of compounded positron emission tomography
drugs and the special techniques and processes required to
produce these drugs, not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall establish--
(i) appropriate procedures for the approval of compounded
positron emission tomography drugs pursuant to section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and
(ii) appropriate current good manufacturing practice
requirements for such drugs.
(B) Considerations and consultation.--In establishing the
procedures and requirements required by subparagraph (A), the
Secretary of Health and Human Services shall take due account
of any relevant differences between not-for-profit
institutions that compound the drugs for their patients and
commercial manufacturers of the drugs. Prior to establishing
the procedures and requirements, the Secretary of Health and
Human Services shall consult with patient advocacy groups,
professional associations, manufacturers, and physicians and
scientists licensed to make or use compounded positron
emission tomography drugs.
(2) Submission of new drug applications and abbreviated new
drug applications.--
(A) In general.--Except as provided in subparagraph (B),
the Secretary of Health and Human Services shall not require
the submission of new drug applications or abbreviated new
drug applications under subsection (b) or (j) of section 505
(21 U.S.C. 355), for compounded positron emission tomography
drugs that are not adulterated drugs described in section
501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a
period of 4 years after the date of enactment of this Act, or
for 2 years after the date or which the Secretary establishes
procedures and requirements under paragraph (1), whichever is
later.
(B) Exception.--Nothing in this Act shall prohibit the
voluntary submission of such applications or the review of
such applications by the Secretary of Health and Human
Services. Nothing in this Act shall constitute an exemption
for a compounded positron emission tomography drug from the
requirements of regulations issued under section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))
for such drugs.
(d) Revocation of Certain Inconsistent Documents.--Within
30 days after the date of enactment of this Act, the
Secretary of Health and Human Services shall publish in the
Federal Register a notice terminating the application of the
following notices and rule, to the extent the notices and
rule relate to compounded positron emission tomography drugs:
(1) A notice entitled ``Regulation of Positron Emission
Tomographic Drug Products: Guidance; Public Workshop'',
published in the Federal Register on February 27, 1995.
(2) A notice entitled ``Guidance for Industry: Current Good
Manufacturing Practices for Positron Emission Tomographic
(PET) Drug Products; Availability'', published in the Federal
Register on April 22, 1997.
(3) A final rule entitled ``Current Good Manufacturing
Practice for Finished Pharmaceuticals; Positron Emission
Tomography'', published in the Federal Register on April 22,
1997.
(e) Definition.--As used in this section, the term
``compounded positron emission tomography drug'' has the
meaning given the term in section 201 of the Federal Food,
Drug and Cosmetic Act (21 U.S.C. 321).
SEC. 620. DISCLOSURE.
Chapter IV (21 U.S.C. 341 et seq.) is amended by adding
after section 403B the following:
``disclosure
``Sec. 403C. (a) No provision of section 403(a), 201(n), or
409 shall be construed to require on the label or labeling of
a food a separate radiation disclosure statement that is more
prominent than the declaration of ingredients required by
section 403(i)(2).
``(b) In this section, the term `radiation disclosure
statement' means a written statement that discloses that a
food or a component of the food has been intentionally
subject to radiation.''.
SEC. 621. REFERRAL STATEMENTS RELATING TO FOOD NUTRIENTS.
Section 403(r)(2)(B) (21 U.S.C. 343(r)(2)(B)) is amended to
read as follows:
``(B) If a claim described in subparagraph (1)(A) is made
with respect to a nutrient in a food, and the Secretary makes
a determination that the food contains a nutrient at a level
that increases to persons in the general population the risk
of a disease or health-related condition that is diet
related, then the label or labeling of such food shall
contain, prominently and in immediate proximity to such
claim, the following statement: `See nutrition information
panel for __ content.' The blank shall identify the nutrient
associated with the increased disease or health-related
condition risk. In making the determination described in this
clause, the Secretary shall take into account the
significance of the food in the total daily diet.''.
TITLE VII--FEES RELATING TO DRUGS
SEC. 701. SHORT TITLE.
This title may be cited as the ``Prescription Drug User Fee
Reauthorization Act of 1997''.
SEC. 702. FINDINGS.
Congress finds that--
(1) prompt approval of safe and effective new drugs and
other therapies is critical to the improvement of the public
health so that patients may enjoy the benefits provided by
these therapies to treat and prevent illness and disease;
(2) the public health will be served by making additional
funds available for the purpose of augmenting the resources
of the Food
[[Page S9861]]
and Drug Administration that are devoted to the process for
review of human drug applications;
(3) the provisions added by the Prescription Drug User Fee
Act of 1992 have been successful in substantially reducing
review times for human drug applications and should be--
(A) reauthorized for an additional 5 years, with certain
technical improvements; and
(B) carried out by the Food and Drug Administration with
new commitments to implement more ambitious and comprehensive
improvements in regulatory processes of the Food and Drug
Administration; and
(4) the fees authorized by amendments made in this title
will be dedicated toward expediting the drug development
process and the review of human drug applications as set
forth in the goals identified in appropriate letters from the
Secretary of Health and Human Services to the chairman of the
Committee on Commerce of the House of Representatives and the
chairman of the Committee on Labor and Human Resources of the
Senate.
SEC. 703. DEFINITIONS.
Section 735 (21 U.S.C. 379g) is amended--
(1) in the second sentence of paragraph (1)--
(A) by striking ``Service Act, and'' and inserting
``Service Act,''; and
(B) by striking ``September 1, 1992.'' and inserting the
following: ``September 1, 1992, does not include an
application for a licensure of a biological product for
further manufacturing use only, and does not include an
application or supplement submitted by a State or Federal
Government entity for a drug or biological product that is
not distributed commercially. Such term does include an
application for licensure, as described in subparagraph (D),
of a large volume biological product intended for single dose
injection for intravenous use or infusion.'';
(2) in the second sentence of paragraph (3)--
(A) by striking ``Service Act, and'' and inserting
``Service Act,''; and
(B) by striking ``September 1, 1992.'' and inserting the
following: ``September 1, 1992, does not include a biological
product that is licensed for further manufacturing use only,
and does not include a drug or biological product that is not
distributed commercially and is the subject of an application
or supplement submitted by a State or Federal Government
entity. Such term does include a large volume biological
product intended for single dose injection for intravenous
use or infusion.'';
(3) in paragraph (4), by striking ``without'' and inserting
``without substantial'';
(4) by striking paragraph (5) and inserting the following:
``(5) The term `prescription drug establishment' means a
foreign or domestic place of business which is at 1 general
physical location consisting of 1 or more buildings all of
which are within 5 miles of each other, at which 1 or more
prescription drug products are manufactured in final dosage
forms.'';
(5) in paragraph (7)(A)--
(A) by striking ``employees under contract'' and all that
follows through ``Administration,'' and inserting
``contractors of the Food and Drug Administration,''; and
(B) by striking ``and committees,'' and inserting ``and
committees and to contracts with such contractors,'';
(6) in paragraph (8)--
(A) in subparagraph (A)--
(i) by striking ``August of '' and inserting ``April of '';
and
(ii) by striking ``August 1992'' and inserting ``April
1997'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) 1 plus the decimal expression of the total percentage
increase for such fiscal year since fiscal year 1997 in basic
pay under the General Schedule in accordance with section
5332 of title 5, United States Code, as adjusted by any
locality-based comparability payment pursuant to section
5304 of such title for Federal employees stationed in the
District of Columbia.''; and
(C) by striking the second sentence; and
(7) by adding at the end the following:
``(9) The term `affiliate' means a business entity that has
a relationship with a second business entity if, directly or
indirectly--
``(A) 1 business entity controls, or has the power to
control, the other business entity; or
``(B) a third party controls, or has power to control both
of the business entities.''.
SEC. 704. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is
amended--
(1) by striking ``Beginning in fiscal year 1993'' and
inserting ``Beginning in fiscal year 1998'';
(2) in paragraph (1)--
(A) by striking subparagraph (B) and inserting the
following:
``(B) Payment.--The fee required by subparagraph (A) shall
be due upon submission of the application or supplement.'';
(B) in subparagraph (D)--
(i) in the subparagraph heading, by striking ``not
accepted'' and inserting ``refused'';
(ii) by striking ``50 percent'' and inserting ``75
percent'';
(iii) by striking ``subparagraph (B)(i)'' and inserting
``subparagraph (B)''; and
(iv) by striking ``not accepted'' and inserting
``refused''; and
(C) by adding at the end the following:
``(E) Exception for designated orphan drug or indication.--
A human drug application for a prescription drug product that
has been designated as a drug for a rare disease or condition
pursuant to section 526 shall not be subject to a fee under
subparagraph (A), unless the human drug application includes
indications for other than rare diseases or conditions. A
supplement proposing to include a new indication for a rare
disease or condition in a human drug application shall not be
subject to a fee under subparagraph (A), provided that the
drug has been designated pursuant to section 526 as a drug
for a rare disease or condition with regard to the indication
proposed in such supplement.
``(F) Exception for supplements for pediatric
indications.--A supplement to a human drug application for an
indication for use in pediatric populations shall not be
assessed a fee under subparagraph (A).
``(G) Refund of fee if application withdrawn.--If an
application or supplement is withdrawn after the application
or supplement is filed, the Secretary may waive and refund
the fee or a portion of the fee if no substantial work was
performed on the application or supplement after the
application or supplement was filed. The Secretary shall have
the sole discretion to waive and refund a fee or a portion of
the fee under this subparagraph. A determination by the
Secretary concerning a waiver or refund under this paragraph
shall not be reviewable.'';
(3) by striking paragraph (2) and inserting the following:
``(2) Prescription drug establishment fee.--
``(A) In general.--Each person that--
``(i) is named as the applicant in a human drug
application; and
``(ii) after September 1, 1992, had pending before the
Secretary a human drug application or supplement;
shall be assessed an annual fee established in subsection (b)
for each prescription drug establishment listed in its
approved human drug application as an establishment that
manufactures the prescription drug product named in the
application. The annual establishment fee shall be assessed
in each fiscal year in which the prescription drug product
named in the application is assessed a fee under paragraph
(3) unless the prescription drug establishment listed in the
application does not engage in the manufacture of the
prescription drug product during the fiscal year. The
establishment fee shall be payable on or before January 31 of
each year. Each such establishment shall be assessed only 1
fee per establishment, notwithstanding the number of
prescription drug products manufactured at the establishment.
In the event an establishment is listed in a human drug
application by more than 1 applicant, the establishment fee
for the fiscal year shall be divided equally and assessed
among the applicants whose prescription drug products are
manufactured by the establishment during the fiscal year and
assessed product fees under paragraph (3).
``(B) Exception.--If, during the fiscal year, an applicant
initiates or causes to be initiated the manufacture of a
prescription drug product at an establishment listed in its
human drug application--
``(i) that did not manufacture the product in the previous
fiscal year; and
``(ii) for which the full establishment fee has been
assessed in the fiscal year at a time before manufacture of
the prescription drug product was begun;
the applicant will not be assessed a share of the
establishment fee for the fiscal year in which manufacture of
the product began.''; and
(4) in paragraph (3)--
(A) in subparagraph (A)--
(i) in clause (i), by striking ``is listed'' and inserting
``has been submitted for listing''; and
(ii) by striking ``Such fee shall be payable'' and all that
follows through ``section 510.'' and inserting the following:
``Such fee shall be payable for the fiscal year in which the
product is first submitted for listing under section 510, or
for relisting under section 510 if the product has been
withdrawn from listing and relisted. After such fee is paid
for that fiscal year, such fee shall be payable on or before
January 31 of each year. Such fee shall be paid only once for
each product for a fiscal year in which the fee is
payable.''; and
(B) in subparagraph (B), by striking ``505(j).'' and
inserting the following: ``505(j), or under an abbreviated
new drug application pursuant to regulations in effect prior
to the implementation of the Drug Price Competition and
Patent Term Restoration Act of 1984, or is a product approved
under an application filed under section 507 that is
abbreviated.''.
(b) Fee Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is
amended to read as follows:
``(b) Fee Amounts.--Except as provided in subsections (c),
(d), (f), and (g), the fees required under subsection (a)
shall be determined and assessed as follows:
``(1) Application and supplement fees.--
``(A) Full fees.--The application fee under subsection
(a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338
in each of fiscal years 1999 and 2000, $267,606 in fiscal
year 2001, and $258,451 in fiscal year 2002.
``(B) Other fees.--The fee under subsection (a)(1)(A)(ii)
shall be $125,352 in fiscal year 1998, $128,169 in each of
fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and
$129,226 in fiscal year 2002.
``(2) Fee revenues for establishment fees.--The total fee
revenues to be collected
[[Page S9862]]
in establishment fees under subsection (a)(2) shall be
$35,600,000 in fiscal year 1998, $36,400,000 in each of
fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001,
and $36,700,000 in fiscal year 2002.
``(3) Total fee revenues for product fees.--The total fee
revenues to be collected in product fees under subsection
(a)(3) in a fiscal year shall be equal to the total fee
revenues collected in establishment fees under subsection
(a)(2) in that fiscal year.''.
(c) Increases and Adjustments.--Section 736(c) (21 U.S.C.
379h(c)) is amended--
(1) in the subsection heading, by striking ``Increases
and'';
(2) in paragraph (1)--
(A) by striking ``(1) Revenue'' and all that follows
through ``increased by the Secretary'' and inserting the
following: ``(1) Inflation adjustment.--The fees and total
fee revenues established in subsection (b) shall be adjusted
by the Secretary'';
(B) in subparagraph (A), by striking ``increase'' and
inserting ``change'';
(C) in subparagraph (B), by striking ``increase'' and
inserting ``change''; and
(D) by adding at the end the following flush sentence:
``The adjustment made each fiscal year by this subsection
will be added on a compounded basis to the sum of all
adjustments made each fiscal year after fiscal year 1997
under this subsection.'';
(3) in paragraph (2), by striking ``October 1, 1992,'' and
all that follows through ``such schedule.'' and inserting the
following: ``September 30, 1997, adjust the establishment and
product fees described in subsection (b) for the fiscal year
in which the adjustment occurs so that the revenues collected
from each of the categories of fees described in paragraphs
(2) and (3) of subsection (b) shall be set to be equal to the
revenues collected from the category of application and
supplement fees described in paragraph (1) of subsection
(b).''; and
(4) in paragraph (3), by striking ``paragraph (2)'' and
inserting ``this subsection''.
(d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C.
379h(d)) is amended--
(1) by redesignating paragraphs (1), (2), (3), and (4) as
subparagraphs (A), (B), (C), and (D), respectively, and
indenting appropriately;
(2) by striking ``The Secretary shall grant a'' and all
that follows through ``finds that--'' and inserting the
following:
``(1) In general.--The Secretary shall grant a waiver from
or a reduction of 1 or more fees assessed under subsection
(a) where the Secretary finds that--'';
(3) in subparagraph (C) (as so redesignated by paragraph
(1)), by striking ``, or'' and inserting a comma;
(4) in subparagraph (D) (as so redesignated by paragraph
(1)), by striking the period and inserting ``, or'';
(5) by inserting after subparagraph (D) (as so redesignated
by paragraph (1)) the following:
``(E) the applicant is a small business submitting its
first human drug application to the Secretary for review.'';
and
(6) by striking ``In making the finding in paragraph (3),''
and all that follows through ``standard costs.'' and
inserting the following:
``(2) Use of standard costs.--In making the finding in
paragraph (1)(C), the Secretary may use standard costs.
``(3) Rules relating to small businesses.--
``(A) Definition.--In paragraph (1)(E), the term `small
business' means an entity that has fewer than 500 employees,
including employees of affiliates.
``(B) Waiver of application fee.--The Secretary shall waive
under paragraph (1)(E) the application fee for the first
human drug application that a small business or its affiliate
submits to the Secretary for review. After a small business
or its affiliate is granted such a waiver, the small business
or its affiliate shall pay--
``(i) application fees for all subsequent human drug
applications submitted to the Secretary for review in the
same manner as an entity that does not qualify as a small
business; and
``(ii) all supplement fees for all supplements to human
drug applications submitted to the Secretary for review in
the same manner as an entity that does not qualify as a small
business.''.
(e) Assessment of Fees.--Section 736(f)(1) (21 U.S.C.
379h(f)(1)) is amended--
(1) by striking ``fiscal year 1993'' and inserting ``fiscal
year 1997''; and
(2) by striking ``fiscal year 1992'' and inserting ``fiscal
year 1997 (excluding the amount of fees appropriated for such
fiscal year)''.
(f) Crediting and Availability of Fees.--Section 736(g) (21
U.S.C. 379h(g)) is amended--
(1) in paragraph (1), by adding at the end the following:
``Such sums as may be necessary may be transferred from the
Food and Drug Administration salaries and expenses
appropriation account without fiscal year limitation to such
appropriation account for salaries and expenses with such
fiscal year limitation. The sums transferred shall be
available solely for the process for the review of human drug
applications within the meaning of section 735(6).'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``Acts'' and inserting
``Acts, or otherwise made available for obligation,''; and
(B) in subparagraph (B), by striking ``over such costs for
fiscal year 1992'' and inserting ``over such costs, excluding
costs paid from fees collected under this section, for fiscal
year 1997''; and
(3) by striking paragraph (3) and inserting the following:
``(3) Authorization of appropriations.--There is authorized
to be appropriated for fees under this section--
``(A) $106,800,000 for fiscal year 1998;
``(B) $109,200,000 for fiscal year 1999;
``(C) $109,200,000 for fiscal year 2000;
``(D) $114,000,000 for fiscal year 2001; and
``(E) $110,100,000 for fiscal year 2002,
as adjusted to reflect adjustments in the total fee revenues
made under this section and changes in the total amounts
collected by application, supplement, establishment, and
product fees.
``(4) Offset.--Any amount of fees collected for a fiscal
year which exceeds the amount of fees specified in
appropriation Acts for such fiscal year, shall be credited to
the appropriation account of the Food and Drug Administration
as provided in paragraph (1), and shall be subtracted from
the amount of fees that would otherwise be authorized to be
collected under appropriation Acts for a subsequent fiscal
year.''.
(g) Requirement for Written Requests for Waivers,
Reductions, and Fees.--Section 736 (21 U.S.C. 379h) is
amended--
(1) by redesignating subsection (i) as subsection (j); and
(2) by inserting after subsection (h) the following:
``(i) Written Requests for Waivers, Reductions, and
Refunds.--To qualify for consideration for a waiver or
reduction under subsection (d), or for a refund, of any fee
collected in accordance with subsection (a), a person shall
submit to the Secretary a written request for such waiver,
reduction, or refund not later than 180 days after such fee
is due.''.
(h) Special Rule for Waiver, Refunds, and Exceptions.--Any
requests for waivers, refunds, or exceptions for fees paid
prior to the date of enactment of this Act shall be submitted
in writing to the Secretary of Health and Human Services
within 1 year after the date of enactment of this Act.
SEC. 705. ANNUAL REPORTS.
(a) First Report.--Beginning with fiscal year 1998, not
later than 60 days after the end of each fiscal year during
which fees are collected under part 2 of subchapter C of
chapter VII of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379g et seq.), the Secretary of Health and Human
Services shall prepare and submit to the Committee on
Commerce of the House of Representatives and the Committee on
Labor and Human Resources of the Senate a report concerning
the progress of the Food and Drug Administration in achieving
the goals identified in the letter described in section
702(4) during such fiscal year and the future plans of the
Food and Drug Administration for meeting the goals.
(b) Second Report.--Beginning with fiscal year 1998, not
later than 120 days after the end of each fiscal year during
which fees are collected under the part described in
subsection (a), the Secretary of Health and Human Services
shall prepare and submit to the Committee on Commerce of the
House of Representatives and the Committee on Labor and Human
Resources of the Senate a report on the implementation of the
authority for such fees during such fiscal year and the use,
by the Food and Drug Administration, of the fees collected
during such fiscal year for which the report is made.
SEC. 706. EFFECTIVE DATE.
The amendments made by this title shall take effect October
1, 1997.
SEC. 707. TERMINATION OF EFFECTIVENESS.
The amendments made by sections 703 and 704 cease to be
effective October 1, 2002 and section 705 ceases to be
effective 120 days after such date.
TITLE VIII--MISCELLANEOUS
SEC. 801. REGISTRATION OF FOREIGN ESTABLISHMENTS.
Section 510(i) (21 U.S.C. 360(i)) is amended to read as
follows:
``(i)(1) Any establishment within any foreign country
engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or a device that is
imported or offered for import into the United States shall
register with the Secretary the name and place of business of
the establishment and the name of the United States agent for
the establishment.
``(2) The establishment shall also provide the information
required by subsection (j).
``(3) The Secretary is authorized to enter into cooperative
arrangements with foreign countries to ensure that adequate
and effective means are available for purposes of
determining, from time to time, whether drugs or devices
manufactured, prepared, propagated, compounded, or processed
by an establishment described in paragraph (1), if imported
or offered for import into the United States, shall be
refused admission on any of the grounds set forth in section
801(a).''.
SEC. 802. ELIMINATION OF CERTAIN LABELING REQUIREMENTS.
(a) Prescription Drugs.--Section 503(b)(4) (21 U.S.C.
353(b)(4)) is amended to read as follows:
``(4)(A) A drug that is subject to paragraph (1) shall be
deemed to be misbranded if at any time prior to dispensing
the label of the drug fails to bear, at a minimum, the symbol
`Rx only'.
``(B) A drug to which paragraph (1) does not apply shall be
deemed to be misbranded
[[Page S9863]]
if at any time prior to dispensing the label of the drug
bears the symbol described in subparagraph (A).''.
(b) Misbranded Drug.--Section 502(d) (21 U.S.C. 352(d)) is
repealed.
(c) Conforming Amendments.--
(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended--
(A) by striking subparagraph (A); and
(B) by redesignating subparagraphs (B) and (C) as
subparagraphs (A) and (B), respectively.
(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by
striking ``section 502(d) and''.
(3) Section 102(9)(A) of the Controlled Substances Act (21
U.S.C. 802(9)(A)) is amended--
(A) in clause (i), by striking ``(i)''; and
(B) by striking ``(ii)'' and all that follows.
SEC. 803. CLARIFICATION OF SEIZURE AUTHORITY.
Section 304(d)(1) (21 U.S.C. 334(d)(1)) is amended--
(1) in the fifth sentence, by striking ``paragraphs (1) and
(2) of section 801(e)'' and inserting ``subparagraphs (A) and
(B) of section 801(e)(1)''; and
(2) by inserting after the fifth sentence the following:
``Any person seeking to export an imported article pursuant
to any of the provisions of this subsection shall establish
that the article was intended for export at the time the
article entered commerce.''.
SEC. 804. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section
203, is further amended by adding at the end the following:
``SEC. 907. INTRAMURAL RESEARCH TRAINING AWARD PROGRAM.
``(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, may, directly or through
grants, contracts, or cooperative agreements, conduct and
support intramural research training in regulatory scientific
programs by predoctoral and postdoctoral scientists and
physicians, including support through the use of fellowships.
``(b) Limitation on Participation.--A recipient of a
fellowship under subsection (a) may not be an employee of the
Federal Government.
``(c) Special Rule.--The Secretary, acting through the
Commissioner of Food and Drugs, may support the provision of
assistance for fellowships described in subsection (a)
through a Cooperative Research and Development Agreement.''.
SEC. 805. DEVICE SAMPLES.
(a) Recall Authority.--
(1) In general.--Section 518(e)(2) (21 U.S.C. 360h(e)(2))
is amended by adding at the end the following:
``(C) If the Secretary issues an amended order under
subparagraph (A), the Secretary may require the person
subject to the order to submit such samples of the device and
of components of the device as the Secretary may reasonably
require. If the submission of such samples is impracticable
or unduly burdensome, the requirement of this subparagraph
may be met by the submission of complete information
concerning the location of 1 or more such devices readily
available for examination and testing.''.
(2) Technical amendment.--Section 518(e)(2)(A) (21 U.S.C.
360h(e)(2)(A)) is amended by striking ``subparagraphs (B) and
(C)'' and inserting ``subparagraph (B)''.
(b) Records and Reports on Devices.--Section 519(a) (21
U.S.C. 360i(a)) is amended by inserting after paragraph (9)
the following:
``(10) may reasonably require a manufacturer or importer to
submit samples of a device and of components of the device
that may have caused or contributed to a death or serious
injury, except that if the submission of such samples is
impracticable or unduly burdensome, the requirement of this
paragraph may be met by the submission of complete
information concerning the location of 1 or more such devices
readily available for examination and testing.''.
SEC. 806. INTERSTATE COMMERCE.
Section 709 (21 U.S.C. 379a) is amended by striking ``a
device'' and inserting ``a device, food, drug, or cosmetic''.
SEC. 807. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS AND
COSMETICS.
(a) Nonprescription Drugs.--Chapter VII (21 U.S.C. 371 et
seq.), as amended by section 614(a), is further amended by
adding at the end the following:
``Subchapter F--National Uniformity for Nonprescription Drugs and
Preemption for Labeling or Packaging of Cosmetics
``SEC. 761. NATIONAL UNIFORMITY FOR NONPRESCRIPTION DRUGS.
``(a) In General.--Except as provided in subsection (b),
(c)(1), (d), (e), or (f), no State or political subdivision
of a State may establish or continue in effect any
requirement--
``(1) that relates to the regulation of a drug that is not
subject to the requirements of section 503(b)(1) or
503(f)(1)(A); and
``(2) that is different from or in addition to, or that is
otherwise not identical with, a requirement under this Act,
the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471
et seq.), or the Fair Packaging and Labeling Act (15 U.S.C.
1451 et seq.).
``(b) Exemption.--
``(1) In general.--Upon application of a State or political
subdivision thereof, the Secretary may by regulation, after
notice and opportunity for written and oral presentation of
views, exempt from subsection (a), under such conditions as
may be prescribed in such regulation, a State or political
subdivision requirement that--
``(A) protects an important public interest that would
otherwise be unprotected, including the health and safety of
children;
``(B) would not cause any drug to be in violation of any
applicable requirement or prohibition under Federal law; and
``(C) would not unduly burden interstate commerce.
``(2) Timely action.--The Secretary shall make a decision
on the exemption of a State or political subdivision
requirement under paragraph (1) not later than 120 days after
receiving the application of the State or political
subdivision under paragraph (1).
``(c) Scope.--
``(1) In general.--This section shall not apply to--
``(A) any State or political subdivision requirement that
relates to the practice of pharmacy; or
``(B) any State or political subdivision requirement that a
drug be dispensed only upon the prescription of a
practitioner licensed by law to administer such drug.
``(2) Safety or effectiveness.--For purposes of subsection
(a), a requirement that relates to the regulation of a drug
shall be deemed to include any requirement relating to public
information or any other form of public communication
relating to a warning of any kind for a drug.
``(d) Exceptions.--
``(1) In general.--In the case of a drug described in
subsection (a)(1) that is not the subject of an application
approved under section 505 or 507 or a final regulation
promulgated by the Secretary establishing conditions under
which the drug is generally recognized as safe and effective
and not misbranded, subsection (a) shall apply only with
respect to a requirement of a State or political subdivision
of a State that relates to the same subject as, but is
different from or in addition to, or that is otherwise not
identical with--
``(A) a regulation in effect with respect to the drug
pursuant to a statute described in subsection (a)(2); or
``(B) any other requirement in effect with respect to the
drug pursuant to an amendment to such a statute made on or
after the date of enactment of this section.
``(2) State initiatives.--This section shall not apply to a
State public initiative enacted prior to the date of
enactment of this section.
``(e) No Effect on Product Liability Law.--Nothing in this
section shall be construed to modify or otherwise affect any
action or the liability of any person under the product
liability law of any State.
``(f) State Enforcement Authority.--Nothing in this section
shall prevent a State or political subdivision thereof from
enforcing, under any relevant civil or other enforcement
authority, a requirement that is identical to a requirement
of this Act.''.
(b) Inspections.--Section 704(a)(1) (21 U.S.C. 374(a)(1))
is amended by striking ``prescription drugs'' each place it
appears and inserting ``prescription drugs, nonprescription
drugs intended for human use,''.
(c) Misbranding.--Paragraph (1) of section 502(e) (21
U.S.C. 352(e)(1)) is amended to read as follows:
``(1)(A) If it is a drug, unless its label bears, to the
exclusion of any other nonproprietary name (except the
applicable systematic chemical name or the chemical
formula)--
``(i) the established name (as defined in subparagraph (3))
of the drug, if there is such a name;
``(ii) the established name and quantity or, if deemed
appropriate by the Secretary, the proportion of each active
ingredient, including the quantity, kind, and proportion of
any alcohol, and also including whether active or not the
established name and quantity or if deemed appropriate by the
Secretary, the proportion of any bromides, ether, chloroform,
acetanilide, acetophenetidin, amidopyrine, antipyrine,
atropine, hyoscine, hyoscyamine, arsenic, digitalis,
digitalis glucosides, mercury, ouabain, strophanthin,
strychnine, thyroid, or any derivative or preparation of any
such substances, contained therein: Provided, That the
requirement for stating the quantity of the active
ingredients, other than the quantity of those specifically
named in this paragraph, shall not apply to nonprescription
drugs not intended for human use; and
``(iii) the established name of each inactive ingredient
listed in alphabetical order on the outside container of the
retail package and, if deemed appropriate by the Secretary,
on the immediate container, as prescribed in regulation
promulgated by the Secretary, but nothing in this clause
shall be deemed to require that any trade secret be divulged:
Provided, That the requirements of this clause with respect
to alphabetical order shall apply only to nonprescription
drugs that are not also cosmetics: and Provided further, That
this clause shall not apply to nonprescription drugs not
intended for human use.
``(B) For any prescription drug the established name of
such drug or ingredient, as the case may be, on such label
(and on any labeling on which a name for such drug or
ingredient is used) shall be printed prominently and in type
at least half as large as that used thereon for any
proprietary name or designation for such drug or ingredient:
Provided, That to the extent that compliance with the
requirements of clause (A)(ii) or (iii) or this clause of
this subparagraph is impracticable, exemptions shall be
established by regulations promulgated by the Secretary.''.
[[Page S9864]]
(d) Cosmetics.--Subchapter F of chapter VII, as amended by
subsection (a), is further amended by adding at the end the
following:
``SEC. 762. PREEMPTION FOR LABELING OR PACKAGING OF
COSMETICS.
``(a) In General.--Except as provided in subsection (b),
(d), or (e), a State or political subdivision of a State
shall not impose or continue in effect any requirement for
labeling or packaging of a cosmetic that is different from or
in addition to, or that is otherwise not identical with a
requirement specifically applicable to a particular cosmetic
or class of cosmetics under this Act, the Poison Prevention
Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair
Packaging and Labeling Act (15 U.S.C. 1451 et seq.).
``(b) Exemption.--Upon application of a State or political
subdivision thereof, the Secretary may by regulation after
notice and opportunity for written and oral presentation of
views, exempt from subsection (a), under such conditions as
may be prescribed in such regulation, a State or political
subdivision requirement for labeling and packaging that--
``(1) protects an important public interest that would
otherwise be unprotected;
``(2) would not cause a cosmetic to be in violation of any
applicable requirements or prohibition under Federal law; and
``(3) would not unduly burden interstate commerce.
``(c) Scope.--For purposes of subsection (a), a reference
to a State requirement that relates to the packaging or
labeling of a cosmetic means any specific requirement
relating to the same aspect of such cosmetic as a requirement
specifically applicable to that particular cosmetic or class
of cosmetics under this Act for packaging or labeling,
including any State requirement relating to public
information or any other form of public communication.
``(d) No Effect on Product Liability Law.--Nothing in this
section shall be construed to modify or otherwise affect any
action or the liability of any person under the product
liability law of any State.
``(e) State Initiative.--This section shall not apply to a
State requirement adopted by a State public initiative or
referendum enacted prior to September 1, 1997.''.
SEC. 808. INFORMATION PROGRAM ON CLINICAL TRIALS FOR SERIOUS
OR LIFE-THREATENING DISEASES.
(a) In General.--Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended--
(1) by redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
(2) by inserting after subsection (i), the following:
``(j)(1) The Secretary, acting through the Director of the
National Institutes of Health and subject to the availability
of appropriations, shall establish, maintain, and operate a
program with respect to information on research relating to
the treatment, detection, and prevention of serious or life-
threatening diseases and conditions. The program shall, with
respect to the agencies of the Department of Health and Human
Services, be integrated and coordinated, and, to the extent
practicable, coordinated with other data banks containing
similar information.
``(2)(A) After consultation with the Commissioner of Food
and Drugs, the directors of the appropriate agencies of the
National Institutes of Health (including the National Library
of Medicine), and the Director of the Centers for Disease
Control and Prevention, the Secretary shall, in carrying out
paragraph (1), establish a data bank of information on
clinical trials for drugs, and biologicals, for serious or
life-threatening diseases and conditions.
``(B) In carrying out subparagraph (A), the Secretary shall
collect, catalog, store, and disseminate the information
described in such subparagraph. The Secretary shall
disseminate such information through information systems,
which shall include toll-free telephone communications,
available to individuals with serious or life-threatening
diseases and conditions, to other members of the public, to
health care providers, and to researchers.
``(3) The data bank shall include the following:
``(A) A registry of clinical trials (whether federally or
privately funded) of experimental treatments for serious or
life-threatening diseases and conditions under regulations
promulgated pursuant to sections 505 and 520 of the Federal
Food, Drug, and Cosmetic Act that provides a description of
the purpose of each experimental drug or biological protocol,
either with the consent of the protocol sponsor, or when a
trial to test efficacy begins. Information provided shall
consist of eligibility criteria, a description of the
location of trial sites, and a point of contact for those
wanting to enroll in the trial, and shall be in a form that
can be readily understood by members of the public. Such
information must be forwarded to the data bank by the sponsor
of the trial not later than 21 days after the approval by the
Food and Drug Administration.
``(B) Information pertaining to experimental treatments for
serious or life-threatening diseases and conditions that may
be available--
``(i) under a treatment investigational new drug
application that has been submitted to the Food and Drug
Administration pursuant to part 312 of title 21, Code of
Federal Regulations; or
``(ii) as a Group C cancer drug.
The data bank may also include information pertaining to the
results of clinical trials of such treatments, with the
consent of the sponsor, including information concerning
potential toxicities or adverse effects associated with the
use or administration of such experimental treatments.
``(4) The data bank shall not include information relating
to an investigation if the sponsor has provided a detailed
certification to the Secretary that disclosure of such
information would substantially interfere with the timely
enrollment of subjects in the investigation, unless the
Secretary, after the receipt of the certification, provides
the sponsor with a detailed written determination that finds
that such disclosure would not substantially interfere with
such enrollment.
``(5) For the purpose of carrying out this subsection,
there are authorized to be appropriated such sums as may be
necessary. Fees collected under section 736 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h) shall not be
authorized or appropriated for use in carrying out this
subsection.''.
(b) Collaboration and Report.--
(1) In general.--The Secretary of Health and Human
Services, the Director of the National Institutes of Health,
and the Commissioner of Food and Drugs shall collaborate to
determine the feasibility of including device investigations
within the scope of the registry requirements set forth in
subsection (j) of section 402 of the Public Health Service
Act.
(2) Report.--Not later than 2 years after the date of
enactment of this section, the Secretary of Health and Human
Services shall prepare and submit to the Committee on Labor
and Human Resources of the Senate and the Committee on
Commerce of the House of Representatives a report that shall
consider, among other things--
(A) the public health need, if any, for inclusion of device
investigations within the scope of the registry requirements
set forth in subsection (j) of section 402 of the Public
Health Service Act; and
(B) the adverse impact, if any, on device innovation and
research in the United States if information relating to such
device investigation is required to be publicly disclosed.
SEC. 809. APPLICATION OF FEDERAL LAW TO THE PRACTICE OF
PHARMACY COMPOUNDING.
Section 503 (21 U.S.C. 353) is amended by adding at the end
the following:
``(h)(1) Sections 501(a)(2)(B), 502(f)(1), 502(l), 505, and
507 shall not apply to a drug product if--
``(A) the drug product is compounded for an identified
individual patient, based on a medical need for a compounded
product--
``(i) by a licensed pharmacist in a State licensed pharmacy
or a Federal facility, or a licensed physician, on the
prescription order of a licensed physician or other licensed
practitioner authorized by State law to prescribe drugs; or
``(ii) by a licensed pharmacist or licensed physician in
limited quantities, prior to the receipt of a valid
prescription order for the identified individual patient, and
is compounded based on a history of the licensed pharmacist
or licensed physician receiving valid prescription orders for
the compounding of the drug product that have been generated
solely within an established relationship between the
licensed pharmacist, or licensed physician, and--
``(I) the individual patient for whom the prescription
order will be provided; or
``(II) the physician or other licensed practitioner who
will write such prescription order; and
``(B) the licensed pharmacist or licensed physician--
``(i) compounds the drug product using bulk drug
substances--
``(I) that--
``(aa) comply with the standards of an applicable United
States Pharmacopeia or National Formulary monograph; or
``(bb) in a case in which such a monograph does not exist,
are drug substances that are covered by regulations issued by
the Secretary under paragraph (3);
``(II) that are manufactured by an establishment that is
registered under section 510 (including a foreign
establishment that is registered under section 510(i)); and
``(III) that are accompanied by valid certificates of
analysis for each bulk drug substance;
``(ii) compounds the drug product using ingredients (other
than bulk drug substances) that comply with the standards of
an applicable United States Pharmacopeia or National
Formulary monograph and the United States Pharmacopeia
chapter on pharmacy compounding;
``(iii) only advertises or promotes the compounding service
provided by the licensed pharmacist or licensed physician and
does not advertise or promote the compounding of any
particular drug, class of drug, or type of drug;
``(iv) does not compound a drug product that appears on a
list published by the Secretary in the Federal Register of
drug products that have been withdrawn or removed from the
market because such drug products or components of such drug
products have been found to be unsafe or not effective;
``(v) does not compound a drug product that is identified
by the Secretary in regulation as presenting demonstrable
difficulties for compounding that reasonably demonstrate an
adverse effect on the safety or effectiveness of that drug
product; and
``(vi) does not distribute compounded drugs outside of the
State in which the drugs are compounded, unless the principal
State
[[Page S9865]]
agency of jurisdiction that regulates the practice of
pharmacy in such State has entered into a memorandum of
understanding with the Secretary regarding the regulation of
drugs that are compounded in the State and are distributed
outside of the State, that provides for appropriate
investigation by the State agency of complaints relating to
compounded products distributed outside of the State.
``(2)(A) The Secretary shall, after consultation with the
National Association of Boards of Pharmacy, develop a
standard memorandum of understanding for use by States in
complying with paragraph (1)(B)(vi).
``(B) Paragraph (1)(B)(vi) shall not apply to a licensed
pharmacist or licensed physician, who does not distribute
inordinate amounts of compounded products outside of the
State, until--
``(i) the date that is 180 days after the development of
the standard memorandum of understanding; or
``(ii) the date on which the State agency enters into a
memorandum of understanding under paragraph (1)(B)(vi),
whichever occurs first.
``(3) The Secretary, after consultation with the United
States Pharmacopeia Convention Incorporated, shall promulgate
regulations limiting compounding under paragraph
(1)(B)(i)(I)(bb) to drug substances that are components of
drug products approved by the Secretary and to other drug
substances as the Secretary may identify.
``(4) The provisions of paragraph (1) shall not apply--
``(A) to compounded positron emission tomography drugs as
defined in section 201(ii); or
``(B) to radiopharmaceuticals.
``(5) In this subsection, the term `compound' does not
include to mix, reconstitute, or perform another similar act,
in accordance with directions contained in approved drug
labeling provided by a drug manufacturer and other drug
manufacturer directions consistent with that labeling.''.
SEC. 810. REPORTS OF POSTMARKETING APPROVAL STUDIES.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.), as
amended by section 613(a), is further amended by adding at
the end the following:
``SEC. 562. REPORTS OF POSTMARKETING STUDIES.
``(a) Submission.--
``(1) In general.--A sponsor of a drug that has entered
into an agreement with the Secretary to conduct a
postmarketing study of a drug shall submit to the Secretary,
within 1 year after the approval of such drug and annually
thereafter until the study is completed or terminated, a
report of the progress of the study or the reasons for the
failure of the sponsor to conduct the study. The report shall
be submitted in such form as prescribed by the Secretary in
regulations issued by the Secretary.
``(2) Agreements prior to effective date.--An agreement
entered into between the Secretary and a sponsor of a drug,
prior to the date of enactment of this section, to conduct a
postmarketing study of a drug shall be subject to the
requirements of paragraph (1). An initial report for such an
agreement shall be submitted within 6 months after the date
of the issuance of the regulations under paragraph (1).
``(b) Consideration of Information as Public Information.--
Any information pertaining to a report described in paragraph
(1) shall be considered to be public information to the
extent that the information is necessary--
``(1) to identify the sponsor; and
``(2) to establish the status of a study described in
subsection (a) and the reasons, if any, for any failure to
carry out the study.
``(c) Status of Studies and Reports.--The Secretary shall
annually develop and publish in the Federal Register a report
that provides a status of the postmarketing studies--
``(1) that sponsors have entered into agreements to
conduct; and
``(2) for which reports have been submitted under
subsection (a)(1).''.
(b) Report to Congressional Committees.--Not later than
October 1, 2001, the Secretary shall prepare and submit to
the Committee on Labor and Human Resources of the Senate and
the Committee on Commerce of the House of Representatives a
report containing--
(1) a summary of the reports submitted under section 562 of
the Federal Food, Drug, and Cosmetic Act; and
(2) an evaluation of--
(A) the performance of the sponsors in fulfilling the
agreements with respect to the conduct of postmarketing
studies described in such section of such Act;
(B) the timeliness of the Secretary's review of the
postmarketing studies; and
(C) any legislative recommendations respecting
postmarketing studies.
SEC. 811. INFORMATION EXCHANGE.
(a) In General.--Chapter VII (2 U.S.C. 371 et seq.), as
amended by section 807, is further amended by adding at the
end the following:
``Subchapter G--Dissemination of Treatment Information
``SEC. 771. DISSEMINATION OF TREATMENT INFORMATION ON DRUGS,
BIOLOGICAL PRODUCTS, AND DEVICES.
``(a) Dissemination of Treatment Information.--
``(1) In general.--Notwithstanding sections 301(d), 502(f),
505, and 507 and section 351 of the Public Health Service Act
(42 U.S.C. 262), and subject to the requirements of
paragraphs (2) through (6) and subsection (b), a manufacturer
may disseminate to a health care practitioner, a pharmacy
benefit manager, a health maintenance organization or other
managed health care organization, or a health care insurer or
governmental agency, written information concerning the
safety, effectiveness, or benefit (whether or not such
information is contained in the official labeling) of a drug,
biological product, or device for which--
``(A) an approval of an application filed under section
505(b), 505(j), or 515, a clearance in accordance with
section 510(k), an approval in accordance with section 507,
or a biologics license issued under section 351 of the Public
Health Service Act, is in effect; and
``(B) if the use is not described in the approved labeling
of the product, the manufacturer has submitted to the
Secretary a certification that a supplemental application for
that use will be submitted to the Secretary pursuant to
paragraph (3) or the manufacturer has received an exemption
under paragraph (3)(C).
``(2) Authorized information.--A manufacturer may
disseminate the written information under paragraph (1) only
if the information--
``(A) is in the form of an unabridged--
``(i) reprint or copy of a peer-reviewed article from a
scientific or medical journal (as defined in subsection
(c)(5)) of a clinical investigation, with respect to a drug,
biological product or device, that would be considered to be
scientifically sound by experts qualified by scientific
training or experience to evaluate the safety or
effectiveness of the drug, biological product, or device that
is the subject of such clinical investigation; or
``(ii) reference textbook (as defined in subsection (c)(4))
that includes information about a clinical investigation with
respect to a drug, biological product, or device, that would
be considered to be scientifically sound by experts qualified
by scientific training or experience to evaluate the safety
or effectiveness of the drug, biological product, or device
that is the subject of such clinical investigation; and
``(B) is not false, not misleading, and would not pose a
significant risk to the public health.
``(3) Commitment to file a supplemental application;
incentives for research.--
``(A) In general.--A manufacturer may disseminate
information about a use not described in the approved
labeling of a drug, biological product, or device pursuant to
paragraph (1) only if--
``(i) the manufacturer has submitted to the Secretary a
certification that the studies needed to file a supplemental
application for such use have been completed and such
supplement will be filed within 6 months after the date of
the initial dissemination of information under paragraph (1);
or
``(ii)(I) the manufacturer has submitted to the Secretary a
proposed protocol and schedule for conducting the studies
needed to submit a supplemental application for such use and
has certified that the supplement will be submitted within 36
months after the date of the initial dissemination of
information under paragraph (1); and
``(II) the Secretary has determined that the protocol for
conducting such studies is adequate and that the schedule for
completing such studies is reasonable.
``(B) Extension.--
``(i) Longer period of time.--The Secretary may grant a
longer period of time for a manufacturer to submit a
supplemental application pursuant to subparagraph (A) if the
Secretary determines that the studies needed to submit a
supplemental application cannot be completed and submitted
within 36 months.
``(ii) Extension of 3-year period.--The Secretary may
extend the time within which a manufacturer must submit a
supplemental application pursuant to subparagraph (A) if the
manufacturer demonstrates that the manufacturer has acted
with due diligence to conduct the studies in a timely manner.
Such extension shall not exceed a period of 24 months.
``(C) Exemptions.--A manufacturer may file a request for an
exemption from the requirements set forth in subparagraph
(A). Such request shall be submitted in the form and manner
prescribed by the Secretary and shall demonstrate that--
``(i) due to the size of the patient population or the lack
of potential benefit to the sponsor, the cost of obtaining
clinical information and submitting a supplemental
application is economically prohibitive; or
``(ii) it would be unethical to conduct the studies
necessary to obtain adequate evidence for approval of a
supplemental application.
The Secretary shall act on a request for an exemption under
this subparagraph within 60 days after the receipt of the
request. If the Secretary fails to act within 60 days, the
manufacturer may begin to disseminate information pursuant to
paragraph (1) without complying with subparagraph (A). If the
Secretary subsequently denies the request for an exemption,
the manufacturer either shall cease dissemination or shall
comply with the requirements of subparagraph (A) within 60
days after such denial. If the manufacturer ceases
dissemination pursuant to this subparagraph solely on the
basis that the manufacturer does not comply with subparagraph
(A), the Secretary may take appropriate corrective action,
but may not order the manufacturer to take corrective action.
``(D) Report.--A manufacturer who submits a certification
to the Secretary under
[[Page S9866]]
subparagraph (A) shall provide the Secretary periodic reports
that describe the status of the studies being conducted to
obtain adequate evidence for approval of a supplemental
application.
``(4) Information on new uses.--
``(A) In general.--If the information being disseminated
under paragraph (1) meets the requirements of this section, a
manufacturer may disseminate information under paragraph (1)
concerning the new use of a drug, biological product, or
device (described in paragraph (1)) 60 calendar days after
the manufacturer has submitted to the Secretary--
``(i) a copy of the information; and
``(ii) any clinical trial information the manufacturer has
relating to the safety or efficacy of the new use, any
reports of clinical experience pertinent to the safety of the
new use, and a summary of such information.
If any of the information required to be provided under
clause (ii) has already been provided to the Secretary, the
manufacturer may meet the requirements of clause (ii) by
providing any such information obtained by the manufacturer
since the manufacturer's last submission to the Secretary and
a summary that identifies the information previously
provided.
``(B) Additional information.--If the Secretary determines
that the information submitted by a manufacturer under
subparagraph (A)(i) with respect to a new use of a drug,
biological product, or device fails to provide data,
analyses, or other written matter, that is objective and
balanced, the Secretary may require the manufacturer to
disseminate along with the information described in
subparagraph (A)--
``(i) additional information with respect to the new use of
the drug, biological product, or device that--
``(I) is in the form of an article described in paragraph
(2)(A); and
``(II) provides data, analyses, or other written matter,
that is scientifically sound;
``(ii) additional objective and scientifically sound
information that pertains to the safety or efficacy of the
use and is necessary to provide objectivity and balance,
including any information that the manufacturer has submitted
to the Secretary, or where appropriate, a summary of such
information, or any other information that the Secretary has
authority to make available to the public;
``(iii) an objective statement prescribed by the Secretary
based on information described in clause (i) or (ii),
provided the manufacturer has access to the data that forms
the basis of such statement unless the Secretary is
prohibited from making such data available to the
manufacturer; and
``(iv) a statement that describes any previous public
announcements by the Secretary relevant to the new use.
``(5) New information.--If a manufacturer that is
disseminating information pursuant to paragraph (1) becomes
aware of new information relating to the safety or efficacy
of a new use of a drug, biological product, or device for
which information was disseminated under paragraph (1), the
manufacturer shall notify the Secretary with respect to the
new information. If the Secretary determines that the new
information demonstrates that a drug, biological product, or
device may not be effective or may present a significant risk
to public health, the Secretary shall, in consultation with
the manufacturer, take such appropriate action as the
Secretary determines necessary to ensure public health and
safety. The Secretary may limit the types of new information
that must be submitted under this paragraph.
``(6) Cessation of dissemination; corrective action.--The
Secretary may order a manufacturer to cease the dissemination
of all information being disseminated pursuant to paragraph
(1) if--
``(A) the Secretary finds that a supplemental application
does not contain adequate information for approval for the
use that is the subject of the information;
``(B) the Secretary determines, after an informal hearing,
that the manufacturer is not acting with due diligence to
complete the studies necessary to file a supplemental
application for the use that is the subject of the
information being disseminated; or
``(C) the Secretary determines that the information being
disseminated does not comply with the requirements set forth
in this section, after providing notice, an opportunity for a
meeting, and for minor violations of this section (if there
has been substantial compliance with this section), an
opportunity to correct such information.
If the Secretary orders cessation of dissemination pursuant
to this paragraph, the Secretary may order the manufacturer
to take appropriate corrective action.
``(7) Sponsored research.--If a manufacturer has sponsored
research that results in information as described in
paragraph (2)(A), another manufacturer may not distribute the
information under this section, unless such manufacturer is
required by the Secretary to distribute the information.
``(b) Disclosure Statement.--In order to afford a full and
fair evaluation of the information described in subsection
(a), a manufacturer disseminating the information shall
include along with the information--
``(1) a prominently displayed statement that discloses--
``(A) that the information concerns a use of a drug,
biological product, or device or other attribute of a drug,
biological product, or device that has not been approved by
the Food and Drug Administration;
``(B) if applicable, that the information is being
disseminated at the expense of the manufacturer;
``(C) if applicable, the name of any authors of the
information who are employees of, or consultants to, or have
received compensation from, the manufacturer, or who have a
significant financial interest in the manufacturer;
``(D) the official labeling for the drug, biological
product, or device and all updates with respect to the
labeling;
``(E) if applicable, a statement that there are products or
treatments that have been approved for the use that is the
subject of the information being disseminated pursuant to
subsection (a)(1); and
``(F) the identification of any person that has provided
funding for the conduct of a study relating to a new use of a
drug, biological product, or device for which such
information is being disseminated; and
``(2) a bibliography of other articles from a scientific
reference textbook or scientific or medical journal that have
been previously published about the new use of a drug,
biological product, or device covered by the information
disseminated (unless the information already includes such
bibliography).
``(c) Definitions.--As used in this section:
``(1) Health care practitioner.--The term `health care
practitioner' means a medical provider that is licensed to
prescribe a drug or biological product, or to prescribe or
use a device, for the treatment of a disease or other medical
condition.
``(2) Manufacturer.--The term `manufacturer' includes a
person who manufactures, distributes, or markets a drug,
biological product, or device.
``(3) New use.--The term `new use' used with respect to a
drug, biological product, or device means a use of a drug,
biological product, or device not included in the approved
labeling of such drug, biological product, or device.
``(4) Reference textbook.--The term `reference textbook'
means a reference publication that--
``(A) has not been written, edited, excerpted, or published
specifically for, or at the request of a manufacturer of a
drug, biological product, or device;
``(B) has not been edited or significantly influenced by a
manufacturer of a drug, biological product, or device;
``(C) is not solely distributed through a manufacturer of a
drug, biological product, or device but is generally
available in bookstores or other distribution channels where
medical textbooks are sold;
``(D) does not focus on any particular drug, biological
product, or device of a manufacturer that disseminates
information under subsection (a), and does not have a primary
focus on new uses of drugs, biological products, or devices
that are marketed or under investigation by a manufacturer
supporting the dissemination of information; and
``(E) presents materials that are not false or misleading.
``(5) Scientific or medical journal.--The term `scientific
or medical journal' means a scientific or medical
publication--
``(A) that is published by an organization--
``(i) that has an editorial board;
``(ii) that utilizes experts, who have demonstrated
expertise in the subject of an article under review by the
organization and who are independent of the organization, to
review and objectively select, reject, or provide comments
about proposed articles; and
``(iii) that has a publicly stated policy, to which the
organization adheres, of full disclosure of any conflict of
interest or biases for all authors or contributors involved
with the journal or organization;
``(B) whose articles are peer-reviewed and published in
accordance with the regular peer-review procedures of the
organization;
``(C) that is generally recognized to be of national scope
and reputation;
``(D) that is indexed in the Index Medicus of the National
Library of Medicine of the National Institutes of Health;
``(E) that presents materials that are not false or
misleading; and
``(F) that is not in the form of a special supplement that
has been funded in whole or in part by 1 or more
manufacturers.
``(d) Construction.--Nothing in this section shall be
construed as prohibiting a manufacturer from disseminating
information in response to an unsolicited request from a
health care practitioner.
``(e) Studies and Reports.--
``(1) General accounting office.--
``(A) In general.--The Comptroller General of the United
States shall conduct a study to determine the impact of this
section on the resources of the Department of Health and
Human Services.
``(B) Report.--Not later than January 1, 2002, the
Comptroller General of the United States shall prepare and
submit to the Committee on Labor and Human Resources of the
Senate and the Committee on Commerce of the House of
Representatives a report of the results of the study.
``(2) Department of health and human services.--
``(A) In general.--In order to assist Congress in
determining whether the provisions of this section should be
extended beyond the termination date specified in section
811(e) of the Food and Drug Administration Modernization and
Accountability Act of 1997, the Secretary of Health and Human
Services shall, in accordance with subparagraph (B),
[[Page S9867]]
arrange for the conduct of a study of the scientific issues
raised as a result of the enactment of this section,
including issues relating to--
``(i) the effectiveness of this section with respect to the
provision of useful scientific information to health care
practitioners;
``(ii) the quality of the information being disseminated
pursuant to the provisions of this section;
``(iii) the quality and usefulness of the information
provided, in accordance with this section, by the Secretary
or by the manufacturer at the request of the Secretary; and
``(iv) the impact of this section on research in the area
of new uses, indications, or dosages, particularly the impact
on pediatric indications and rare diseases.
``(3) Procedure for study.--
``(A) In general.--The Secretary shall request the
Institute of Medicine of the National Academy of Sciences to
conduct the study required by paragraph (2), and to prepare
and submit the report required by subparagraph (B), under an
arrangement by which the actual expenses incurred by the
Institute of Medicine in conducting the study and preparing
the report will be paid by the Secretary. If the Institute of
Medicine is unwilling to conduct the study under such an
arrangement, the Secretary shall enter into a similar
arrangement with another appropriate nonprofit private group
or association under which the group or association will
conduct the study and prepare and submit the report.
``(B) Report.--Not later than September 30, 2005, the
Institute of Medicine, the group, or association, as
appropriate, shall prepare and submit to the Committee on
Labor and Human Resources of the Senate, the Committee on
Commerce of the House of Representatives, and the Secretary a
report of the results of the study required by paragraph (2).
The Secretary, after the receipt of the report, shall make
the report available to the public.
``(4) Authorization of appropriation.--There are authorized
to be appropriated such sums as are necessary to carry out
this subsection.
``SEC. 772. ESTABLISHMENT OF LIST OF ARTICLES AND TEXTBOOKS
DISSEMINATED AND LIST OF PROVIDERS THAT
RECEIVED ARTICLES AND REFERENCE TEXTBOOKS.
``(a) In General.--A manufacturer that disseminates
information in the form of articles or reference textbooks
under section 771 shall prepare and submit to the Secretary
biannually--
``(1) a list containing the titles of the articles and
reference textbooks relating to the new use of drugs,
biological products, and devices that were disseminated by
the manufacturer to a person described in section 771(a)(1)
for the 6-month period preceding the date on which the
manufacturer submits the list to the Secretary; and
``(2) a list that identifies the categories of providers
(as described in section 771(a)(1)) that received the
articles and reference textbooks for the 6-month period
described in paragraph (1).
``(b) Records.--A manufacturer that disseminates
information under section 771 shall keep records that
identify the recipients of articles and textbooks provided
pursuant to section 771. Such records are to be used by the
manufacturer when, pursuant to section 771(a)(6), such
manufacturer is required to take corrective action and shall
be made available to the Secretary, upon request, for
purposes of ensuring or taking corrective action pursuant to
paragraph (3), (5), or (6) of section 771(a).
``SEC. 773. CONSTRUCTION.
``(a) Dissemination of Information on Drugs or Devices Not
Evidence of Intended Use.--Notwithstanding subsection (a),
(f), or (o) of section 502, or any other provision of law,
the dissemination of information relating to a new use of a
drug or device, in accordance with section 771, shall not be
construed by the Secretary as evidence of a new intended use
of the drug or device that is different from the intended use
of the drug or device set forth in the official labeling of
the drug or device. Such dissemination shall not be
considered by the Secretary as labeling, adulteration, or
misbranding of the drug or device.
``(b) Patent Protection.--Nothing in section 771 shall
affect patent rights in any manner.
``(c) Authorization for Dissemination of Articles and Fees
for Reprints of Articles.--Nothing in section 771 shall be
construed as prohibiting an entity that publishes a
scientific journal (as defined in section 771(c)(5)) from
requiring authorization from the entity to disseminate an
article published by such entity and from charging fees for
the purchase of reprints of published articles from such
entity.''.
(b) Prohibited Act.--Section 301 (21 U.S.C. 331), as
amended by section 205(b), is further amended by adding at
the end the following:
``(y) The dissemination of information pursuant to section
771 by a manufacturer who fails to comply with the
requirements of such section.''.
(c) Regulations.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations to implement the
amendments made by this section.
(d) Effective Date.--The amendments made by this section
shall take effect 1 year after the date of enactment of this
Act, or upon the Secretary's issuance of final regulations
pursuant to subsection (c), whichever is sooner.
(e) Termination of Effectiveness.--The amendments made by
this section cease to be effective September 30, 2006, or 7
years after the date on which the Secretary promulgates the
regulations described in subsection (c), whichever is later.
SEC. 812. REAUTHORIZATION OF CLINICAL PHARMACOLOGY PROGRAM.
Section 2 of Public Law 102-222 (105 Stat. 1677) is
amended--
(1) in subsection (a), by striking ``a grant'' and all that
follows through ``Such grant'' and inserting the following:
``grants for a pilot program for the training of individuals
in clinical pharmacology at appropriate medical schools. Such
grants''; and
(2) in subsection (b), by striking ``to carry out this
section'' and inserting ``, and for fiscal years 1998 through
2002 $3,000,000 for each fiscal year, to carry out this
section''.
SEC. 813. MONOGRAPH FOR SUNBURN PRODUCTS.
Not later than 18 months after the date of enactment of
this Act, the Secretary of Health and Human Services shall
issue a final monograph for over-the-counter sunburn products
for prevention or treatment of sunburn.
SEC. 814. SAFETY REPORT DISCLAIMERS.
Chapter IX (21 U.S.C. 391 et seq.), as amended by section
804, is further amended by adding at the end the following:
``SEC. 908. SAFETY REPORT DISCLAIMERS.
``With respect to any entity that submits or is required to
submit a safety report or other information in connection
with the safety of a product (including a product which is a
food, drug, new drug, device, dietary supplement, or
cosmetic) under this Act (and any release by the Secretary of
that report or information), such report or information shall
not be construed to necessarily reflect a conclusion by the
entity or the Secretary that the report or information
constitutes an admission that the product involved caused or
contributed to an adverse experience, or otherwise caused or
contributed to a death, serious injury, serious illness, or
malfunction. Such an entity need not admit, and may deny,
that the report or information submitted by the entity
constitutes an admission that the product involved caused or
contributed to an adverse experience or caused or contributed
to a death, serious injury, serious illness, or
malfunction.''.
Mr. JEFFORDS. Mr. President, I move to reconsider the vote.
Mr. COATS. I move to lay that motion on the table.
The motion to lay on the table was agreed to.
Mr. JEFFORDS. Mr. President, I thank my colleagues and I thank them
profusely for their vote, for their support in the committee, and all
the work that has gone into this. But, as we all know, there are people
who work behind the scenes, those who are probably more responsible for
this vote than we on the floor are. I just want to take a moment to
thank the staff.
In the office of Senate Legislative Counsel, Robin Bates, Elizabeth
Aldridge, and Bill Baird worked tirelessly to produce countless bill
drafts and amendments. And how they came out with them as expeditiously
as they did, I'm not sure.
The staff at CRS, especially Donna Vogt, and at GAO, including
Bernice Steinhardt deserve thanks for their willingness to provide
essential information and documents on extremely short notice. We must
always remember to appreciate these organizations that provide so much
assistance to the Congress.
The staff to the members of the committee contributed greatly to the
success of this bill. In particular, Vince Ventimiglia with Senator
Coats' staff worked closely with ours in a true partnership on all
aspects of S. 830.
In addition, Kimberly Spaulding with Senator Gregg, Sue Ramthun with
Senator Frist, Saira Sultan with Senator DeWine, and Kate Lambrew-Hull
with Senator Hutchinson all played important roles in fashioning
compromises on key provisions of this bill. Also, Mark Smith with
Senator Mack's staff worked very hard to make the agreement on off-
label dissemination of information possible.
I would also like to thank the many staff of the administration who
have worked on this legislation.
In particular, I want to thank Bill Schultz, Diane Thompson, and
Peggy Dotzel, of the FDA.
Similarly, three staffers for members of the minority on the
committee played pivotal roles even before committee markup took place
in making this bill a bipartisan success.
Lynne Lawrence with Senator Mikulski deserves special mention in
recognition of her hard work in the last Congress on FDA reform and her
willingness to put her future career plans
[[Page S9868]]
on hold to commit herself again to the long hard job of bringing this
bill to the floor this year. Jeanne Ireland with Senator Dodd and Linda
DeGutis, a fellow with Senator Wellstone also provided invaluable
assistance.
Of course I would like to thank the Labor and Human Resources
Committee majority and minority staffs who did the most work on this.
In particular, I want to recognize Susan Hattan who stayed on with the
committee after Senator Kassebaum's retirement.
She, and another Senator Kassebaum staffer, Jane Williams, who is now
on the staff of Representative Fred Upton, worked long hours last year
to put FDA reform on the Senate agenda and brought a bill to successful
committee markup in the last Congress--we stand here today in large
part due to their hard work.
On the minority staff, I would like to thank Nick Littlefield and
David Nexon and two minority fellows Diane Robertson and Debbie
Kochever. Finally, I would like to thank the majority staff director
Mark Powden, Jay Hawkins, and majority fellow Sean Donohue.
I want to take a moment to elaborate on my comments regarding one of
the majority staff who has worked so diligently on this measure--Jay
Hawkins. Jay joined my staff in January--literally hit the ground
running--and I don't think he has stopped moving since.
He has set a new standard of dedication for professional staff to
find the best solution in a difficult and controversial policy arena.
He has been saluted by other Senators' staffs, from both majority and
minority offices, for his willingness to include them in all aspects of
this effort.
Mr. President, part of the job description for Senate staff is to
take abuse. Jay unfortunately received more than his share, but it said
more about his critics than him.
More recently--a little more than a month ago--Jay lost his mother to
her 4-year battle with cancer. My friend, Senator Hatch, acknowledged
on the floor just yesterday this hardship Jay faced and was eloquent in
his praise for both Jay and for his mother--Donna Lotz Hawkins. Mrs.
Hawkins was not unfamiliar with challenge and adversity. She was an
experienced mountain climber and conquered some of the world's most
difficult mountains in the Alaska range, the Tetons, the Alps, and the
Himalayas. She was a dedicated ocean swimmer and conquered the white
waters in Waikiki and Maui.
It is clear to us who know Jay that he too has the spirit of taking
on the task when faced with adversity and challenge. We know the source
of that sense of commitment and we cannot thank him enough for his
efforts on this bill.
I yield the floor.
The PRESIDING OFFICER. The Senator from Massachusetts.
Mr. KENNEDY. Mr. President, in typical fashion, Senator Jeffords has
given great credit where credit is due, and as I mentioned just before,
the chairman of our committee really deserves credit for the passage of
this very important bill. I commend him.
If I could, I will just take a moment of the Senate's time, but I
think it is important to mention on our side David Nexon and Diane
Robertson, who worked so closely with us; Jim Manly, Debbie Kochevar,
Meg Archdeacon, Burt Cowgill, Susan Hammersten, Jonathan Halperin, and
Danielle Drissel, Carrie Coberly and Addy Schmidt; Bonnie Hogue on
Senator Reed's staff and Deborah Walker on Senator Bingaman's staff;
Sabrina Corlette with Senator Harkin and Anne-Marie Murphy with Senator
Durbin.
I would like to believe the staffs have been helpful to all of us and
don't work so much in a partisan way as in a common spirit, to try to
advance the common interests. That has been, certainly, true on this
legislation.
I thank all of those, and the majority staff as well, for all of
their courtesies and for their cooperation. I think the record ought to
show the dedication of, really, an outstanding group of men and women
who have really served the Senate very, very well. I thank the
chairman.
Mr. JEFFORDS. Mr. President, I thank the ranking minority member on
my committee for his words. I commend him, also. We disagreed rather
strongly on one issue here, but 19 out of 20 we were together and
worked together, and certainly that's a pretty good average.
Mr. President, I suggest the absence of a quorum.
The PRESIDING OFFICER. The clerk will call the roll.
The legislative clerk proceeded to call the roll.
Mr. FAIRCLOTH. Mr. President, I ask unanimous consent that the order
for the quorum call be rescinded.
The PRESIDING OFFICER. Without objection, it is so ordered.
____________________