Closing Loopholes for Orphan Drugs Act

Bill: 116-hr-4538
Sponsor: full_name: Rep. Welch, Peter [D-VT-At Large]
Introduced: 2019-09-26
Policy area: Health
Subjects: Drug therapy

Health care costs and insurance

Inflation and prices

Prescription drugs
Latest action: action_date: 2019-09-27
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2019-09-26
action_desc: Introduced in House
text: <p><b>Closing Loopholes for Orphan Drugs Act</b></p> <p>This bill amends the Public Health Service Act to revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (i.e., drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program. </p>

tv_txt: I 116th CONGRESS 1st Session H. R. 4538 IN THE HOUSE OF REPRESENTATIVES September 26, 2019 Mr. Welch (for himself and Mr. McKinley ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title.

1. Short title This Act may be cited as the Closing Loopholes for Orphan Drugs Act . 2. Limiting the orphan drug exclusion under 340B drug discount program (a) In general Section 340B(e) of the Public Health Service Act ( 42 U.S.C. 256b(e) ) is amended by inserting before the period at the end the following: when transferred, prescribed, sold, or otherwise used for the rare condition or disease for which such drug is so designated . (b) Effective date The amendment made by subsection (a) shall apply with respect to covered outpatient drugs purchased on or after the date of the enactment of this Act.