[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1353 Introduced in House (IH)]

114th CONGRESS
  1st Session
                                H. R. 1353

To amend the Federal Food, Drug, and Cosmetic Act to extend the period 
 of exclusivity with respect to certain drugs, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 13, 2015

Mr. Bilirakis (for himself, Mr. Connolly, Mr. Israel, and Mr. Griffith) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to extend the period 
 of exclusivity with respect to certain drugs, and for other purposes.

    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 ``Promoting Access for Treatments 
Ideal in Enhancing New Therapies Act of 2015'', or the ``PATIENT Act of 
2015''.

SEC. 2. EXTENDED EXCLUSIVITY PERIOD FOR CERTAIN NEW DRUG APPLICATIONS 
              AND ABBREVIATED NEW DRUG APPLICATIONS.

    (a) New Drug Applications.--Section 505(c)(3)(E) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(c)(3)(E)) is amended by 
adding at the end the following new clause:
            ``(vi) With respect to an application described in clause 
        (iii) or a supplement to an application described in clause 
        (iv), the three-year period specified in such clause shall be 
        extended for an additional 24-month period if the person 
        submitting such application or supplement provides 
        documentation to the Secretary demonstrating that--
                    ``(I) the new clinical investigations essential to 
                the approval of the application or supplement and 
                conducted or sponsored by the person submitting the 
                application or supplement support the approval of a new 
                indication or use for the drug that is the subject of 
                the application or supplement; or
                    ``(II) the drug that is the subject of the 
                application or supplement has been reformulated or 
                redesigned so that the drug can reasonably (as 
                determined by the Secretary in consultation with the 
                person submitting such application or supplement) be 
                expected--
                            ``(aa) to promote greater patient adherence 
                        to an approved treatment regime relative to the 
                        previously approved formulation or design of 
                        the drug;
                            ``(bb) to reduce the public-health risks 
                        associated with the drug relative to the 
                        previously approved formulation or design of 
                        the drug;
                            ``(cc) to reduce the manner or extent of 
                        side effects or adverse events associated with 
                        the previously approved formulation or design 
                        of the drug;
                            ``(dd) to provide systemic benefits to the 
                        health-care system relative to the previously 
                        approved formulation or design of the drug; or
                            ``(ee) to provide other patient benefits 
                        that are comparable to the benefits described 
                        in items (aa) through (dd).''.
    (b) Abbreviated New Drug Applications.--Section 505(j)(5)(F) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(F)) is 
amended by adding at the end the following new clause:
    ``(vi) With respect to an application described in clause (iii) or 
a supplement to an application described in clause (iv), the three-year 
period specified in such clause shall be extended for an additional 24-
month period if the person submitting such application or supplement 
provides documentation to the Secretary demonstrating that--
            ``(I) the new clinical investigations essential to the 
        approval of the application or supplement and conducted or 
        sponsored by the person submitting the application or 
        supplement support the approval of a new indication or use for 
        the drug that is the subject of the application or supplement; 
        or
            ``(II) the drug that is the subject of the application or 
        supplement has been reformulated or redesigned so that the drug 
        may reasonably (as determined by the Secretary in consultation 
        with the person submitting such application or supplement) be 
        expected--
                    ``(aa) to promote greater patient adherence to an 
                approved treatment regime relative to the previously 
                approved formulation or design of the drug;
                    ``(bb) to reduce the public-health risks associated 
                with the drug relative to the previously approved 
                formulation or design of the drug;
                    ``(cc) to reduce the manner or extent of side 
                effects or adverse events associated with the 
                previously approved formulation or design of the drug;
                    ``(dd) to provide systemic benefits to the health-
                care system relative to the previously approved 
                formulation or design of the drug; or
                    ``(ee) to provide other patient benefits that are 
                comparable to the benefits described in items (aa) 
                through (dd).''.
    (c) Regulations.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services shall 
promulgate final regulations to carry out the amendments made by this 
section, including regulations establishing a process under which the 
Secretary consults with persons who claim eligibility for the extension 
provided by clause (vi) of subsection (c)(3)(E) or (j)(5)(F) of section 
505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) (as 
added by subsections (a) and (b)) regarding how the drug that is the 
subject of such a claim may reasonably be expected to provide a benefit 
described in item (aa), (bb), (cc), (dd), or (ee) of clause (vi)(II) of 
each such subsection.
                                 <all>