Title: Short on Competition Act
Policy area: Health

Summary:
Short on Competition Act
This bill requires the Food and Drug Administration (FDA) to provide temporary authorization to import certain prescription drugs facing shortages or in a marginally competitive drug market.
Specifically, the FDA shall authorize importation of an eligible drug that is lifesaving, life-sustaining, or intended to treat or prevent a debilitating condition. To be eligible, a drug must (1) be facing a shortage, (2) require a prescription, (3) have received market authorization in certain foreign countries, and (4) have the same active ingredient as the drug for which there is a shortage in the United States. The drug's manufacturer must also seek FDA approval for the drug as a generic drug.
The import authorization shall be for three years or until the shortage no longer applies, whichever occurs first. Importation shall begin within 60 days of the FDA receiving an application that meets all of the applicable requirements. The FDA may deny importation of a drug for reasons related to safety or effectiveness.
Drugs in marginally competitive markets must be treated as being in a shortage for the purposes of this bill and for the purposes of expedited inspections and review. A drug is in a marginally competitive market if (1) there are fewer than five holders of approved applications for commercially available brand-name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) the patents on the drug's active ingredients have expired.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 844 Introduced in Senate (IS)]

<DOC>






116th CONGRESS
  1st Session
                                 S. 844

   To allow for expedited approval of generic prescription drugs and 
 temporary importation of prescription drugs in the case of marginally 
              competitive drug markets and drug shortages.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             March 14, 2019

  Ms. Klobuchar (for herself, Mr. Lee, Mr. Durbin, and Mr. Grassley) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
   To allow for expedited approval of generic prescription drugs and 
 temporary importation of prescription drugs in the case of marginally 
              competitive drug markets and drug shortages.

    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 ``Short on Competition Act''.

SEC. 2. TEMPORARY IMPORTATION OF PRESCRIPTION DRUGS.

    (a) Temporary Importation.--Section 506C of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 356c) is amended--
            (1) by redesignating subsections (h) and (i) as subsections 
        (i) and (j), respectively; and
            (2) by inserting after subsection (g) the following:
    ``(h) Temporary Importation Authority.--
            ``(1) In general.--If, based on notifications described in 
        subsection (a) or any other relevant information, the Secretary 
        concludes that there is, or is likely to be, a drug shortage of 
        a drug described in subsection (a), except as provided in 
        paragraph (3), the Secretary shall authorize importation of 
        such drug for a period of up to 3 years if--
                    ``(A) the drug is a drug subject to section 
                503(b)(1), including a combination product whose 
                primary mode of action is that of a drug as determined 
                under section 503(g)(1)(D)(i), other than a drug 
                described in subparagraphs (A) through (F) of section 
                804(a)(3);
                    ``(B) the drug is authorized to be lawfully 
                marketed in one or more of the countries included in 
                the list under section 802(b)(1);
                    ``(C) the imported drug has the same active 
                ingredient as the drug for which there is a shortage 
                with respect to manufacturers in the United States;
                    ``(D) the manufacturer certifies to the Secretary 
                that it intends to seek approval of the drug under 
                section 505(j); and
                    ``(E) an importer (as defined in section 804(a)) 
                files with the Secretary information--
                            ``(i) attesting that the requirements under 
                        subparagraphs (A) through (D) are satisfied;
                            ``(ii) identifying the drug the importer 
                        proposes to import and the manufacturer from 
                        whom the importer proposes to import such drug; 
                        and
                            ``(iii) requesting authority to import the 
                        drug.
            ``(2) Beginning date of importation.--Except as provided in 
        paragraph (3), if all of the conditions under paragraph (1) are 
        met, the Secretary shall authorize importation of a drug in 
        accordance with such paragraph beginning not later than 60 days 
        after receipt of the information under paragraph (1)(E).
            ``(3) Discretionary denial of importation.--The Secretary 
        may deny importation of a drug otherwise qualified for 
        importation under paragraph (1) if the Secretary determines 
        that--
                    ``(A) the drug is not safe and effective;
                    ``(B) the drug is used in conjunction with a device 
                for which there is no reasonable assurance of safety 
                and effectiveness; or
                    ``(C) the authorization to market the drug in one 
                or more of the countries included in the list under 
                section 802(b)(1) has been rescinded or withdrawn 
                because of any concern relating to the safety or 
                effectiveness of the drug.
            ``(4) Termination of authority.--The authority to import a 
        drug pursuant to paragraph (1) shall terminate after 3 years, 
        or when the drug shortage no longer applies, whichever occurs 
        first.''.
    (b) Marginally Competitive Drug Markets.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 506C-1 the following:

``SEC. 506C-2. MARGINALLY COMPETITIVE DRUG MARKETS.

    ``(a) In General.--If the Secretary determines under subsection (b) 
that a marginally competitive market exists with respect to an 
applicable drug, the Secretary--
            ``(1) shall treat such marginally competitive market as 
        creating a drug shortage only for purposes of subsections (g) 
        and (h) of section 506C; and
            ``(2)(A) may expedite the review of applications and 
        inspections with respect to the drug in accordance with section 
        506C(g); and
            ``(B) shall authorize importation of the drug in accordance 
        with section 506C(h).
    ``(b) Determination of Marginally Competitive Market.--
            ``(1) In general.--The Secretary shall determine that a 
        marginally competitive market exists with respect to an 
        applicable drug if--
                    ``(A) for at least 2 consecutive months prior to 
                the determination, fewer than 5 drugs approved under 
                section 505(c) (referred to in this paragraph as the 
                `applicable listed drug') or under section 505(j) that 
                reference the applicable listed drug were commercially 
                available in the United States;
                    ``(B) the applicable listed drug was approved at 
                least 10 years before such determination; and
                    ``(C) each patent which claims an active ingredient 
                of the applicable listed drug has expired.
            ``(2) Commercially available.--
                    ``(A) In general.--For purposes of paragraph 
                (1)(A), a drug is not commercially available in the 
                United States if--
                            ``(i) the holder of an application approved 
                        under subsection (c) or (j) of section 505 has 
                        publicly announced that it has discontinued the 
                        manufacturing of the drug;
                            ``(ii) a drug approved under subsection (c) 
                        or (j) of section 505 has been withdrawn or 
                        discontinued; or
                            ``(iii) the Secretary has any other 
                        reasonable basis to conclude that a drug 
                        approved under subsection (c) or (j) of section 
                        505 is not competitively relevant.
                    ``(B) Holder of approved application.--In 
                determining whether 5 drugs are commercially available 
                under paragraph (1)(A), in the case of a single person 
                who is the holder of more than one application approved 
                as described in paragraph (1)(A) with respect to an 
                applicable drug, only one such drug shall be considered 
                to be commercially available.
    ``(c) Applicable Drug.--In this section, the term `applicable drug' 
means a drug that is not a radio pharmaceutical drug product or any 
other product as designated by the Secretary.''.
    (c) Annual Reporting on Drug Shortages.--Section 506C-1(a)(3)(B) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c-1(a)(3)(B)) is 
amended--
            (1) in clause (i), by striking ``; and'' and inserting 
        ``;'';
            (2) in clause (ii), by adding ``and'' after the semicolon; 
        and
            (3) by inserting after clause (ii) the following:
                    ``(iii) the number of drugs authorized for 
                temporary importation under section 506C(h);''.
                                 <all>