[Congressional Record Volume 161, Number 44 (Monday, March 16, 2015)]
[House]
[Pages H1638-H1641]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
IMPROVING REGULATORY TRANSPARENCY FOR NEW MEDICAL THERAPIES ACT
Mr. PITTS. Mr. Speaker, I move to suspend the rules and pass the bill
(H.R. 639) to amend the Controlled Substances Act with respect to drug
scheduling recommendations by the Secretary of Health and Human
Services, and with respect to registration of manufacturers and
distributors seeking to conduct clinical testing, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 639
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 ``Improving Regulatory
Transparency for New Medical Therapies Act''.
SEC. 2. SCHEDULING OF SUBSTANCES INCLUDED IN NEW FDA-APPROVED
DRUGS.
(a) Effective Date of Approval.--
(1) Effective date of drug approval.--Section 505 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is
amended by adding at the end the following:
[[Page H1639]]
``(x) Date of Approval in the Case of Recommended Controls
Under the CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the Secretary
provides notice to the sponsor that the Secretary intends to
recommend controls under the Controlled Substances Act,
approval of such application shall not take effect until the
interim final rule controlling the drug is issued in
accordance with section 201(j) of the Controlled Substances
Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1), the
term `date of approval' shall mean the later of--
``(A) the date an application under subsection (b) is
approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(2) Effective date of approval of biological products.--
Section 351 of the Public Health Service Act (42 U.S.C. 262)
is amended by adding at the end the following:
``(n) Date of Approval in the Case of Recommended Controls
Under the CSA.--
``(1) In general.--In the case of an application under
subsection (a) with respect to a biological product for which
the Secretary provides notice to the sponsor that the
Secretary intends to recommend controls under the Controlled
Substances Act, approval of such application shall not take
effect until the interim final rule controlling the
biological product is issued in accordance with section
201(j) of the Controlled Substances Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1),
references to the date of approval of such application, or
licensure of the product subject to such application, shall
mean the later of--
``(A) the date an application is approved under subsection
(a); or
``(B) the date of issuance of the interim final rule
controlling the biological product.''.
(3) Effective date of approval of animal drugs.--
(A) In general.--Section 512 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b) is amended by adding at the end
the following:
``(q) Date of Approval in the Case of Recommended Controls
Under the CSA.--
``(1) In general.--In the case of an application under
subsection (b) with respect to a drug for which the Secretary
provides notice to the sponsor that the Secretary intends to
recommend controls under the Controlled Substances Act,
approval of such application shall not take effect until the
interim final rule controlling the drug is issued in
accordance with section 201(j) of the Controlled Substances
Act.
``(2) Date of approval.--For purposes of this section, with
respect to an application described in paragraph (1), the
term `date of approval' shall mean the later of--
``(A) the date an application under subsection (b) is
approved under subsection (c); or
``(B) the date of issuance of the interim final rule
controlling the drug.''.
(B) Conditional approval.--Section 571(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360ccc(d)) is amended
by adding at the end the following:
``(4)(A) In the case of an application under subsection (a)
with respect to a drug for which the Secretary provides
notice to the sponsor that the Secretary intends to recommend
controls under the Controlled Substances Act, conditional
approval of such application shall not take effect until the
interim final rule controlling the drug is issued in
accordance with section 201(j) of the Controlled Substances
Act.
``(B) For purposes of this section, with respect to an
application described in subparagraph (A), the term `date of
approval' shall mean the later of--
``(i) the date an application under subsection (a) is
conditionally approved under subsection (b); or
``(ii) the date of issuance of the interim final rule
controlling the drug.''.
(C) Indexing of legally marketed unapproved new animal
drugs.--Section 572 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360ccc-1) is amended by adding at the end the
following:
``(k) In the case of a request under subsection (d) to add
a drug to the index under subsection (a) with respect to a
drug for which the Secretary provides notice to the person
filing the request that the Secretary intends to recommend
controls under the Controlled Substances Act, a determination
to grant the request to add such drug to the index shall not
take effect, and the Secretary shall not list the drug on
such index, until the interim final rule controlling the drug
is issued in accordance with section 201(j) of the Controlled
Substances Act.''.
(4) Date of approval for designated new animal drugs.--
Section 573(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ccc-2(c)) is amended by adding at the end the
following:
``(3) For purposes of determining the 7-year period of
exclusivity under paragraph (1) for a drug for which the
Secretary intends to recommend controls under the Controlled
Substances Act, the drug shall not be considered approved or
conditionally approved until the date that the interim final
rule controlling the drug is issued in accordance with
section 201(j) of the Controlled Substances Act.''.
(b) Scheduling of Newly Approved Drugs.--Section 201 of the
Controlled Substances Act (21 U.S.C. 811) is amended by
inserting after subsection (i) the following:
``(j)(1) With respect to a drug referred to in subsection
(f), if the Secretary of Health and Human Services recommends
that the Attorney General add the drug to schedule II, III,
IV, or V pursuant to subsections (a) and (b), the Attorney
General shall, not later than 90 days after the date
described in paragraph (2), issue an interim final rule
controlling the drug in accordance with such subsections and
section 202(b) using the procedures described in paragraph
(3).
``(2) The date described in this paragraph shall be the
later of--
``(A) the date on which the Attorney General receives the
scientific and medical evaluation and recommendations from
the Secretary of Health and Human Services in accordance with
subsection (b); or
``(B) the date on which the Attorney General receives
notification from the Secretary of Health and Human Services
that the Secretary has approved an application under section
505(c), 512, 571, or 572 of the Federal Food, Drug, and
Cosmetic Act or section 351(a) of the Public Health Service
Act with respect to the drug described in paragraph (1).
``(3) A rule issued by the Attorney General under paragraph
(1) shall be in accordance with the procedures provided in
subsection (a), except that the rule shall become immediately
effective as an interim final rule without requiring the
Attorney General to demonstrate good cause therefor. After
publication of the interim final rule, the Attorney General
shall issue a final rule in accordance with the procedures
provided in subsection (a).''.
(c) Extension of Patent Term.--Section 156 of title 35,
United States Code, is amended--
(1) in subsection (d)(1), in the matter preceding
subparagraph (A), by inserting ``, or in the case of a drug
product described in subsection (i) within the sixty-day
period beginning on the covered date (as defined in
subsection (i))'' after ``marketing or use''; and
(2) by adding at the end the following:
``(i)(1) For purposes of this section, if the Secretary of
Health and Human Services provides notice to the sponsor of
an application or request for approval, conditional approval,
or indexing of a drug product for which the Secretary intends
to recommend controls under the Controlled Substances Act,
beginning on the covered date, the drug product shall be
considered to--
``(A) have been approved under the relevant provision of
the Public Health Service Act or Federal Food, Drug, and
Cosmetic Act; and
``(B) have permission for commercial marketing or use.
``(2) In this subsection, the term `covered date' means the
later of--
``(A) the date an application is approved--
``(i) under section 351(a)(2)(C) of the Public Health
Service Act; or
``(ii) under section 505(b) or 512(c) of the Federal Food,
Drug, and Cosmetic Act;
``(B) the date an application is conditionally approved
under section 571(b) of the Federal Food, Drug, and Cosmetic
Act;
``(C) the date a request for indexing is granted under
section 572(d) of the Federal Food, Drug, and Cosmetic Act;
or
``(D) the date of issuance of the interim final rule
controlling the drug under section 201(j) of the Controlled
Substances Act.''.
SEC. 3. ENHANCING NEW DRUG DEVELOPMENT.
Section 303 of the Controlled Substances Act (21 U.S.C.
823) is amended by adding at the end the following:
``(i)(1) For purposes of registration to manufacture a
controlled substance under subsection (d) for use only in a
clinical trial, the Attorney General shall register the
applicant, or serve an order to show cause upon the applicant
in accordance with section 304(c), not later than 180 days
after the date on which the application is accepted for
filing.
``(2) For purposes of registration to manufacture a
controlled substance under subsection (a) for use only in a
clinical trial, the Attorney General shall, in accordance
with the regulations issued by the Attorney General, issue a
notice of application not later than 90 days after the
application is accepted for filing. Not later than 90 days
after the date on which the period for comment pursuant to
such notice ends, the Attorney General shall register the
applicant, or serve an order to show cause upon the applicant
in accordance with section 304(c), unless the Attorney
General has granted a hearing on the application under
section 1008(i) of the Controlled Substances Import and
Export Act.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Pennsylvania (Mr. Pitts) and the gentleman from Texas (Mr. Gene Green)
each will control 20 minutes.
The Chair recognizes the gentleman from Pennsylvania.
General Leave
Mr. PITTS. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days in which to revise and extend their remarks and
insert extraneous materials into the Record on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Pennsylvania?
[[Page H1640]]
There was no objection.
Mr. PITTS. Mr. Speaker, I yield myself such time as I may consume.
I will include an exchange of letters between the Committee on Energy
and Commerce and the Committee on the Judiciary.
Mr. Speaker, H.R. 639 seeks to improve the transparency and
consistency of the Drug Enforcement Administration's first scheduling
of new FDA-approved drugs under the Controlled Substances Act, the CSA,
and, secondly, its registration process for the manufacture of
controlled substances for use in clinical trials. Ultimately, this will
allow new and innovative treatments to get to patients who desperately
need them.
Due to the cost and uncertainty of the drug development process,
there is broad agreement that a predictable timeline for approval
decisions is a necessary component to successful drug development.
Industry, the FDA, and Congress have taken steps to provide more
transparency and consistency in the drug approval process through the
negotiation and authorization of the Prescription Drug User Fee program
and a commitment to review goals embedded in the PDUFA agreements.
However, drugs that contain substances that have not been previously
marketed in the U.S. and that have abuse potential must also be
scheduled under the Controlled Substances Act, the CSA, by the DEA
before they can reach patients.
Under the CSA, there is no deadline for the DEA to make a scheduling
decision, and the delays in DEA decisions have increased significantly.
Between 1997 and 1999 and 2009 and 2013, the average time between FDA
approval and DEA's final scheduling increased from an average of 49.3
days to an average of 237.6 days. Recently, a company had to wait over
13 months after FDA approval to receive a final scheduling
recommendation from the DEA.
The lack of predictability in the timing of DEA scheduling decisions
leads to unnecessary uncertainty in the drug development process and
needless delays in patient access to new therapies.
Section 2 of H.R. 639, as amended by the full committee, would
require DEA to issue an interim final rule, scheduling the new drug no
later than 90 days after it is approved or when it receives the FDA's
scheduling recommendation, whichever comes later. After receiving the
FDA's recommendation, the DEA would continue to conduct its own
analysis prior to scheduling the drug, but patients would now have
peace of mind in knowing this will no longer be an open-ended process.
Of note: since 1996, the DEA has not made any scheduling decision for a
new drug that was contrary to the FDA recommendation.
Further, section 3 of this bill would bring much-needed certainty to
another open-ended DEA process. Manufacturers of controlled substances
are required to be registered with the DEA. The requirement to register
extends to manufacturers of controlled substances intended to be used
in clinical trials for products not yet approved by the FDA. There is
no timetable for the DEA to grant approval of registration
applications, and there is not a process for the applicant to determine
the reasons for delay in the application. The lack of transparency,
predictability, and timeliness in the registration process leaves
companies unable to properly plan clinical trial schedules for
prospective new therapies.
For registration applications related to schedule III, IV, and V
drugs that will only be used in clinical trials, section 3, as amended
by the full committee, would require the DEA to register the applicant
or serve an order to show cause on why the applicant shall not be
registered within 180 days of the filing of the application.
For drugs in schedule I and II that will only be used in a clinical
trial, the DEA would be required to issue a notice of application not
later than 90 days after an application is accepted for filing. Ninety
days after the end of the comment period, pursuant to the notice, the
DEA would be required to register the applicant or serve an order to
show cause on why the registrant should not be registered.
Such a solution does not force the DEA to make a particular decision
but will provide transparency to the process so companies can better
plan when regulatory decisions will be made.
I would urge all Members to support this critical piece of
legislation.
I reserve the balance of my time.
House of Representatives,
Committee on the Judiciary,
March 16, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce, Rayburn House
Office Building, Washington, DC.
Dear Chairman Upton: I am writing with respect to H.R. 639,
the ``Improving Regulatory Transparency for New Medical
Therapies Act.'' As a result of your having consulted with us
on provisions in H.R. 639 that fall within the Rule X
jurisdiction of the Committee on the Judiciary, I agree to
discharge our Committee from further consideration of this
bill so that it may proceed expeditiously to the House floor
for consideration.
The Judiciary Committee takes this action with our mutual
understanding that by foregoing consideration of H.R. 639 at
this time, we do not waive any jurisdiction over subject
matter contained in this or similar legislation, and that our
Committee will be appropriately consulted and involved as
this bill or similar legislation moves forward so that we may
address any remaining issues in our jurisdiction. Our
Committee also reserves the right to seek appointment of an
appropriate number of conferees to any House-Senate
conference involving this or similar legislation, and asks
that you support any such request.
I would appreciate a response to this letter confirming
this understanding with respect to H.R. 639, and would ask
that a copy of our exchange of letters on this matter be
included in the Congressional Record during Floor
consideration of H.R. 639.
Sincerely,
Bob Goodlatte,
Chairman.
____
House of Representatives,
Committee on Energy and Commerce,
Washington, DC, March 16, 2015.
Hon. Bob Goodlatte,
Chairman, Committee on the Judiciary, Rayburn House Office
Building Washington, DC.
Dear Chairman Goodtette: Thank you for your letter
regarding H.R. 639, the ``Improving Regulatory Transparency
for New Medical Therapies Act.'' As you noted, there are
provisions of the bill that fall within the Committee on the
Judiciary's Rule X jurisdiction.
I appreciate your willingness to forgo action on H.R. 639,
and I agree that your decision is not a waiver of any of the
Committee on the Judiciary's jurisdiction over the subject
matter contained in this or similar legislation, and that the
Committee will be consulted appropriately and involved as the
bill or similar legislation moves forward. In addition, I
understand the Committee reserves the right to seek the
appointment of an appropriate number of conferees to any
House-Senate conference involving this or similar
legislation, for which you will have my support.
I will include a copy of your letter and this response in
the Congressional Record during consideration of H.R. 639 on
the House floor.
Sincerely,
Fred Upton,
Chairman.
Mr. GENE GREEN of Texas. Mr. Speaker, I yield myself as much time as
I may consume.
Mr. Speaker, I rise in support of H.R. 639, the Improving Regulatory
Transparency for New Medical Therapies Act. This legislation was
introduced by the chair of our Health Subcommittee, Joe Pitts of
Pennsylvania; the ranking member of the full committee, Frank Pallone
of New Jersey; and myself to provide a solution to delays experienced
by patients in need.
Currently, new drugs and substances that previously have not been
marketed in the United States and that have abuse potential must be
scheduled by the Drug Enforcement Administration prior to being
marketed.
The amount of time the DEA has taken before acting on FDA
recommendations has significantly lengthened in recent years, which
delays the availability of new therapies.
This legislation will improve patient access by bringing clarity and
transparency to the process of scheduling a new FDA-approved therapy.
I was pleased to join the gentleman from Pennsylvania (Mr. Pitts) and
the gentleman from New Jersey (Mr. Pallone) in supporting this
legislation to continue the great work they started last Congress. I
thank them and their staff for working on this important access issue.
I want to acknowledge the leadership of Chairman Upton and the work
of the committee's minority and majority staff in advancing this bill
through the Energy and Commerce Committee. I
[[Page H1641]]
support this bipartisan bill and urge my colleagues to do the same.
Mr. Speaker, I yield back the balance of my time.
Mr. PITTS. Mr. Speaker, I urge all Members to support this bipartisan
legislation, and I yield back the balance of my time.
Mr. BURGESS. Mr. Speaker, I would like to submit the cost estimate
prepared by the Congressional Budget Office for H.R. 639.
U.S. Congress,
Congressional Budget Office,
Washington, DC, March 16, 2015.
Hon. Fred Upton,
Chairman, Committee on Energy and Commerce, House of
Representatives, Washington, DC.
Dear Mr. Chairman: The Congressional Budget Office has
prepared the enclosed cost estimate for H.R. 639, the
Improving Regulatory Transparency for New Medical Therapies
Act.
If you wish further details on this estimate, we will be
pleased to provide them. The CBO staff contact is Julia
Christensen.
Sincerely,
Douglas W. Elmendorf.
Enclosure.
____
as ordered reported by the house committee on energy and commerce on
february 12, 2015
H.R. 639 would modify the administrative procedures
followed by the Department of Justice in regulating new drugs
that are already approved by the Food and Drug Administration
(FDA) and in authorizing drugs to be used in clinical trials.
The legislation would aim to streamline the current review
and approval process. CBO estimates that implementing the
bill would have no significant effect on spending subject to
appropriation. Enacting the legislation would affect direct
spending and revenues related to federal health care costs;
therefore, pay-as-you-go procedures apply. CBO estimates that
that those effects would also not be significant over the
2015-2025 period.
The legislation would change the effective date of FDA
approval for certain new drugs that undergo review by the
Drug Enforcement Agency (DEA) to determine if the drug should
be marketed with restrictions as a controlled substance. Such
a change could extend certain regulatory periods during which
FDA will not accept marketing applications or permit another
manufacturer to market a version of an affected drug and
could also result in the extension of patent terms for
certain products. Extending such periods of marketing
exclusivity could delay the entry of lower-priced generic
drugs on the market, and such a delay would increase the
average cost for prescription drugs. Any increase in health
care costs resulting from delaying the market entry of
generic drugs would affect direct spending and revenues by
increasing the cost of prescription drugs for federal health
programs and private health insurance.
CBO expects that the bill's provisions would apply to a
limited number of drugs subject to DEA classification after
enactment. Because most drugs generally retain patent
protections after FDA approval for more than 10 years, CBO
anticipates that the likelihood that drugs affected by the
bill will face generic competition before 2025 under current
law would be small. As a result, we estimate that enacting
the bill would not significantly affect direct spending or
revenues over the 2015-2025 period. Beyond 2025, however, the
potential for the legislation to delay the market entry of
generic drugs would be greater, and the effect on direct
spending and revenues would increase in later years.
H.R. 639 contains no intergovernmental mandates as defined
in the Unfunded Mandates Reform Act (UMRA) and would impose
no costs on state, local, or tribal governments. The bill
would impose a private-sector mandate, as defined under UMRA,
on manufacturers of generic drugs by delaying the entry of
those products in the market. The cost of the mandate would
be the net loss of income, which could be significant
depending on the drug. Based on information from industry
sources, CBO estimates that the cost of the mandate would
probably fall below the annual threshold established in UMRA
for private-sector mandates ($154 million in 2015, adjusted
annually for inflation).
The CBO staff contacts for this estimate are Julia
Christensen and Mark Grabowicz (for federal costs) and Amy
Petz (for private sector costs). The estimate was approved by
Theresa Gullo, Deputy Assistant Director for Budget Analysis.
Mr. PALLONE. Mr. Speaker, I am pleased to lend my support to H.R.
639, the Improving Regulatory Transparency for New Medical Therapies
Act. This important public health bill aims to bring better reliability
and transparency to medical therapies, while continuing to ensure that
they reach patients in need quickly, but most importantly safely and
effectively.
When a new drug is approved by the FDA, a company can begin marketing
the product upon its approval. However, for a subset of drugs, FDA
recommends to the DEA they be included in the Controlled Substance
Act--or ``scheduled,'' if there is abuse potential. Until DEA makes a
final decision, a drug cannot be released to the public.
Unfortunately, there is no deadline for the DEA to make a decision.
As a result, the process has lengthened over time, in some instances
lasting years before a decision is made. So even if a drug is
considered safe and effective, patients and physicians are being forced
to wait to access these therapies. This bill would continue to allow
DEA to conduct its own analysis, but would remove much of the
uncertainty from the process. It also would speed up the DEA
registration process allowing the manufacture and distribution of
controlled substances for use only in clinical trials.
I want to thank Chairman Pitts for working with me on this bill last
Congress, and committing to move forward early this Congress. Thank you
to Mr. Green as well for joining us on this important bill.
I am glad that we have been able to work with both DEA and FDA, our
Senate counterparts and the bill sponsors, to ensure that the goals of
this bill is met.
I urge members to support H.R 639 and I look forward to its swift
passage.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Pennsylvania (Mr. Pitts) that the House suspend the
rules and pass the bill, H.R. 639, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
____________________