[Congressional Record (Bound Edition), Volume 161 (2015), Part 3]
[House]
[Pages 3581-3584]
[From the U.S. 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:
       ``(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

[[Page 3582]]

       ``(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?
  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.

[[Page 3583]]

  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 Goodlatte: 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 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.

[[Page 3584]]


       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.

                          ____________________