[Congressional Record Volume 167, Number 64 (Wednesday, April 14, 2021)]
[House]
[Pages H1755-H1756]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




AMENDING FEDERAL FOOD, DRUG, AND COSMETIC ACT WITH RESPECT TO SCOPE OF 
                        NEW CHEMICAL EXCLUSIVITY

  Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the 
bill (S. 415) to amend the Federal Food, Drug, and Cosmetic Act with 
respect to the scope of new chemical exclusivity.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                                 S. 415

       Be it enacted by the Senate and House of Representatives of 
     the United States of America in Congress assembled,

     SECTION 1. CLARIFYING THE MEANING OF NEW CHEMICAL ENTITY.

       (a) In General.--Chapter V of the Federal Food, Drug, and 
     Cosmetic Act is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (B) in subsection (j)(5)(F), by striking ``active 
     ingredient (including any ester or salt of the active 
     ingredient)'' each place it appears and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))'';
       (C) in subsection (l)(2)(A)--
       (i) by amending clause (i) to read as follows:
       ``(i) not later than 30 days after the date of approval of 
     such applications--
       ``(I) for a drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under this section; or
       ``(II) for a biological product, no active ingredient of 
     which has been approved in any other application under 
     section 351 of the Public Health Service Act; and''; and
       (ii) in clause (ii), by inserting ``or biological product'' 
     before the period;
       (D) by amending subsection (s) to read as follows:
       ``(s) Referral to Advisory Committee.--The Secretary 
     shall--
       ``(1) refer a drug or biological product to a Food and Drug 
     Administration advisory committee for review at a meeting of 
     such advisory committee prior to the approval of such drug or 
     biological if it is--
       ``(A) a drug, no active moiety (as defined by the Secretary 
     in section 314.3 of title 21, Code of Federal Regulations (or 
     any successor regulations)) of which has been approved in any 
     other application under this section; or
       ``(B) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act; or
       ``(2) if the Secretary does not refer a drug or biological 
     product described in paragraph (1) to a Food and Drug 
     Administration advisory committee prior to such approval, 
     provide in the action letter on the application for the drug 
     or biological product a summary of the reasons why the 
     Secretary did not refer the drug or biological product to an 
     advisory committee prior to approval.''; and
       (E) in subsection (u)(1), in the matter preceding 
     subparagraph (A)--
       (i) by striking ``active ingredient (including any ester or 
     salt of the active ingredient)'' and inserting ``active 
     moiety (as defined by the Secretary in section 314.3 of title 
     21, Code of Federal Regulations (or any successor 
     regulations))''; and
       (ii) by striking ``same active ingredient'' and inserting 
     ``same active moiety'';
       (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by 
     striking ``active ingredient (including any ester or salt of 
     the active ingredient)'' each place it appears and inserting 
     ``active moiety (as defined by the Secretary in section 314.3 
     of title 21, Code of Federal Regulations (or any successor 
     regulations))'';
       (3) in section 524(a)(4) (21 U.S.C. 360n(a)(4)), by 
     amending subparagraph (C) to read as follows:
       ``(C) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.'';
       (4) in section 529(a)(4) (21 U.S.C. 360ff(a)(4)), by 
     striking subparagraphs (A) and (B) and inserting the 
     following:
       ``(A) is for a drug or biological product that is for the 
     prevention or treatment of a rare pediatric disease;
       ``(B)(i) is for such a drug--
       ``(I) that contains no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) that has been 
     previously approved in any other application under subsection 
     (b)(1), (b)(2), or (j) of section 505; and
       ``(II) that is the subject of an application submitted 
     under section 505(b)(1); or
       ``(ii) is for such a biological product--
       ``(I) that contains no active ingredient that has been 
     previously approved in any other application under section 
     351(a) or 351(k) of the Public Health Service Act; and
       ``(II) that is the subject of an application submitted 
     under section 351(a) of the Public Health Service Act;''; and
       (5) in section 565A(a)(4) (21 U.S.C. 360bbb-4a(a)(4)), by 
     amending subparagraph (D) to read as follows:
       ``(D) is for--
       ``(i) a human drug, no active moiety (as defined by the 
     Secretary in section 314.3 of title 21, Code of Federal 
     Regulations (or any successor regulations)) of which has been 
     approved in any other application under section 505(b)(1); or
       ``(ii) a biological product, no active ingredient of which 
     has been approved in any other application under section 351 
     of the Public Health Service Act.''.
       (b) Technical Corrections.--Chapter V of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended--
       (1) in section 505 (21 U.S.C. 355)--
       (A) in subsection (c)(3)(E), by repealing clause (i); and
       (B) in subsection (j)(5)(F), by repealing clause (i); and
       (2) in section 505A(c)(1)(A)(i)(II) (21 U.S.C. 
     355a(c)(1)(A)(i)(II)), by striking ``(c)(3)(D)'' and 
     inserting ``(c)(3)(E)''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New 
Jersey (Mr. Pallone) and the gentleman from Florida (Mr. Bilirakis) 
each will control 20 minutes.
  The Chair recognizes the gentleman from New Jersey.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to

[[Page H1756]]

revise and extend their remarks and include extraneous material on S. 
415.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, rising prescription drug costs are a concern for so many 
Americans. Skyrocketing costs can result in some people postponing or 
altering treatment because the necessary drugs are simply priced out of 
reach.
  One way to help reduce drug costs is to provide early access to 
generic drugs. This legislation we are considering today will help to 
do that by ensuring that exclusivity, which can delay generics from 
entering the market, is only made available to truly innovative 
products. This will ensure that drug manufacturers cannot game the 
system by simply making small tweaks to old drugs as a way to block or 
delay competition. The legislation will also codify the Food and Drug 
Administration's current approach to awarding exclusivity.
  I thank Representatives Schrader and Guthrie for their bipartisan 
work on this legislation with Senators Cassidy, Smith, and Marshall.
  Mr. Speaker, I urge my colleagues to support the bill, and I reserve 
the balance of my time.
  Mr. BILIRAKIS. Mr. Speaker, I yield myself such time as I may 
consume.
  Mr. Speaker, I rise in support of S. 415, the Ensuring Innovation 
Act. This legislation is the bipartisan companion to H.R. 1857 led by 
Representatives Guthrie and Schrader.
  This legislation would ensure that only the most innovative products 
are eligible for certain market exclusivities and would increase the 
availability of lower-cost generic drugs. Great work by these 
Representatives.
  Currently, the FDA grants 5 years of marketing exclusivity to drug 
products determined to be a new chemical entity. Clarifying what 
qualifies as a new chemical entity will prevent drug manufacturers from 
receiving exclusivity by making minor changes to existing drugs, which 
would block generic competition from the market.
  This important bipartisan legislation will help lower prescription 
drug prices while preserving incentives to innovate.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield such time as he may consume to the 
gentleman from Oregon (Mr. Schrader), a member of the Energy and 
Commerce Committee.
  Mr. SCHRADER. Mr. Speaker, I rise today to speak in support of S. 
415, a bill that has the same policy as my own and Mr. Guthrie's here 
in the House, H.R. 1857, the Protecting Access to Safe and Effective 
Medicines Act.
  This bill is a simple fix, providing clarity around the drug approval 
process by increasing the specificity of the language companies may use 
when submitting these complex and often lengthy applications. Simply 
put, utilizing the term ``active ingredient'' opens the unintended 
opportunity for pharmaceutical companies to make minor, relatively 
nonpharmacological changes to the same chemical and prevent generic 
alternatives from coming to the marketplace. By changing this language, 
as this bill does, to ``active moiety,'' we will be able to close 
another loophole that can be exploited by companies to inappropriately 
obtain exclusivity and hold back competition in the marketplace, the 
key mechanism for lowering drug prices.
  While this is good policy, it is one small piece of the larger drug-
pricing conversation that we need to have. It demonstrates, yet again, 
that the policies to lower drug prices are bipartisan and bicameral. In 
fact, there are many such policies that did not get done in the last 
Congress that offer a starting point for a comprehensive approach 
addressing drug pricing, and now is the time to continue this important 
work.
  I thank my colleagues on both sides of the aisle for the help in 
supporting this important bill before us today, and I urge its passage.
  Mr. BILIRAKIS. Mr. Speaker, I urge my colleagues to pass this great 
bill. I commend my colleagues for focusing on this particular issue, 
which is just so important to our constituents. Again, let's pass this 
bill as soon as possible and get it to the President.
  Mr. Speaker, I yield back the balance of my time.
  Mr. PALLONE. Mr. Speaker, I also urge support for this bill, and I 
yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, S. 415.
  The question was taken; and (two-thirds being in the affirmative) the 
rules were suspended and the bill was passed.
  A motion to reconsider was laid on the table.

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