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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 3387 Introduced in Senate (IS)]

<DOC>

114th CONGRESS
  2d Session
                                S. 3387

     To provide for the fast track review of certain generic drugs.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                           September 22, 2016

  Mr. Cotton introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
     To provide for the fast track review of certain generic drugs.

    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 ``Safely Advancing Valuable and 
Inexpensive New Generic Solutions Act'' or the ``SAVINGS Act''.

SEC. 2. FAST TRACK REVIEW FOR CERTAIN GENERIC DRUGS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)) is amended by adding at the end the following:
            ``(11)(A) Notwithstanding any other provision of law, the 
        Secretary shall prioritize the review of a qualifying 
        application under this subsection and shall, within 150 days of 
        the initial receipt of such qualifying application, take final 
        agency action on the application.
            ``(B) For purposes of this paragraph, the term `qualifying 
        application' means an application--
                    ``(i) that does not contain a certification under 
                subclause (IV) of paragraph (2)(A)(vii);
                    ``(ii) that may contain a certification under 
                subclause (III) of paragraph (2)(A)(vii) only if such 
                certification asserts that an existing patent will 
                expire not more than 5 months after the date of such 
                certification;
                    ``(iii) for a drug where the reference drug is a 
                drug for which there is no exclusivity period in 
                effect, including an exclusivity period under paragraph 
                (5)(F), or under section 505A, section 527, or section 
                505E; and
                    ``(iv) for a drug where the reference drug has not 
                been the reference drug for more than one other drug 
                that--
                            ``(I) is approved under this subsection; 
                        and
                            ``(II) has been introduced into interstate 
                        commerce in the 3-month period preceding the 
                        date of the qualifying application.
            ``(C) Notwithstanding any other provision of this paragraph 
        and regardless of the date of submission, a qualifying 
        application shall lose status as an application for priority 
        review, and the Secretary's timeline for taking action on such 
        an application described in subparagraph (A) shall no longer 
        apply, if the application no longer meets the definition of a 
        qualifying application.''.

SEC. 3. TRANSPARENCY.

    (a) In General.--Not later than 6 months after enactment and every 
6 months thereafter, the Secretary of Health and Human Services, acting 
through the Commissioner of Food and Drugs, shall submit a report to 
the Committee on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Energy and Commerce of the House of 
Representatives containing the information described in subsection (c).
    (b) Definition.--In this section the term ``generic fast track 
review'' means review under paragraph (11) of section 505(j) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)), as added by 
section 2 of this Act.
    (c) Contents of Report.--The report described in subsection (a) 
shall include the following information:
            (1) The number of applications in the most recent 6-month 
        period that are subject to generic fast track review, and which 
        of those applications--
                    (A) are for a drug where the reference drug has not 
                been the reference drug for any other application that 
                is approved under subsection (j) of section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
                    (B) are for a drug where the reference drug has 
                been the reference drug for not more than one other 
                application that is approved under subsection (j) of 
                such section; and
                    (C) are for a drug that is on the drug shortage 
                list established under section 506E of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 356e).
            (2) The average and median time before an applicant 
        receives an approval decision for an application subject to 
        generic fast track review.
            (3) The number of applications subject to generic fast 
        track review that were approved.
            (4) At the time such report is submitted, the number of 
        applications subject to fast track review--
                    (A) that have been withdrawn by the applicant;
                    (B) that have been granted tentative approval;
                    (C) with respect to which the Food and Drug 
                Administration has requested additional information 
                from the sponsor of the application;
                    (D) that are awaiting review by the Food and Drug 
                Administration after additional information has been 
                supplied, as described in subparagraph (C); and
                    (E) with respect to which the Food and Drug 
                Administration has recorded reception of the 
                application but has yet to contact the sponsor 
                regarding the status of the application.
            (5) A prediction of how long the Food and Drug 
        Administration will take to respond to such applications that 
        are awaiting review with either an approval or a rejection, and 
        how many of such applications are expected to be withdrawn by 
        the applicant.
            (6) The average review time for such applications that are 
        receiving generic fast track review versus the standard review 
        period.
            (7) The information described in paragraphs (1) through (6) 
        with respect to applications for drugs under section 505 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) that are 
        subject to another form of priority review or fast-track 
        review.
            (8) An annual accounting of how the Food and Drug 
        Administration has spent the fees it has received under part 7 
        of subchapter C of chapter VII of such Act (21 U.S.C. 379f et 
        seq.) to include the proportion of such fees that such 
        Administration has spent on personnel costs.
                                 <all>
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