H.R. 946

119th CONGRESS 1st Session

To amend title XI of the Social Security Act to expand and clarify the exclusion for orphan drugs under the Drug Price Negotiation Program.

IN THE HOUSE OF REPRESENTATIVES · February 4, 2025 · Sponsor: Mr. Joyce of Pennsylvania

Table of contents

• H.R. 946
  • SEC. 1. Short title
  • SEC. 2. Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program

SEC. 1. Short title

• This Act may be cited as the or the .

SEC. 2. Expanding and clarifying the exclusion for orphan drugs under the Drug Price Negotiation Program

• Section 1192(e) of the Social Security Act () is amended— 42 U.S.C. 1320f–1(e)
  • (C) Treatment of former orphan drugs
    • In calculating the amount of time that has elapsed with respect to the approval of a drug or licensure of a biological product under subparagraph (A)(ii) and subparagraph (B)(ii), respectively, the Secretary shall not take into account any period during which such drug or product was a drug described in paragraph (3)(A).
  • in paragraph (1), by adding at the end the following new subparagraph:
  • in paragraph (3)(A)—
    • by striking only one rare disease or conditionand inserting one or more rare diseases or conditions; and
    • by striking such disease or conditionand inserting one or more rare diseases or conditions (as such term is defined in section 526(a)(2) of the Federal Food, Drug, and Cosmetic Act).