summary
Introduced
01/10/2019
01/10/2019
In Committee
01/25/2019
01/25/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
To significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices at which the drugs are available in other countries. This bill establishes a series of oversight and disclosure requirements relating to the prices of brand-name drugs. Specifically, the bill requires the Department of Health and Human Services (HHS) to review at least annually all brand-name drugs for excessive pricing; HHS must also review prices upon petition. If any such drugs are found to be excessively priced, HHS must (1) void any government-granted exclusivity; (2) issue open, nonexclusive licenses for the drugs; and (3) expedite the review of corresponding applications for generic drugs and biosimilar biological products. HHS must also create a public database with its determinations for each drug. Under the bill, a price is considered excessive if the domestic average manufacturing price exceeds the median price for the drug in Canada, the United Kingdom, Germany, France, and Japan. If a price does not meet this criteria, or if pricing information is unavailable in at least three of the aforementioned countries, the price is still considered excessive if it is higher than reasonable in light of specified factors, including cost, revenue, and the size of the affected patient population. The bill also requires drug manufacturers to report specified financial information for brand-name drugs, including research and advertising expenditures.
AI Summary
This bill aims to significantly lower prescription drug prices for patients in the United States by ending government-granted monopolies for manufacturers who charge drug prices that are higher than the median prices in other countries. The bill establishes a process for the Department of Health and Human Services (HHS) to annually review brand-name drug prices and determine if they are excessive based on international reference prices or other factors. If a drug's price is found to be excessive, the bill requires HHS to void any government-granted exclusivity and issue open, non-exclusive licenses to allow generic or biosimilar competition. The bill also imposes reporting requirements on drug manufacturers to provide detailed financial information about their drugs. The goal is to create more market competition and lower drug prices for American patients.
Committee Categories
Business and Industry, Government Affairs, Health and Social Services
Sponsors (23)
Ro Khanna (D)*,
Elijah Cummings (D),
Danny Davis (D),
Peter DeFazio (D),
Rosa DeLauro (D),
Mark DeSaulnier (D),
Tulsi Gabbard (D),
Debra Haaland (D),
Pramila Jayapal (D),
Barbara Lee (D),
Grace Meng (D),
Debbie Mucarsel-Powell (D),
Joe Neguse (D),
Eleanor Holmes Norton (D),
Alexandria Ocasio-Cortez (D),
Ilhan Omar (D),
Mark Pocan (D),
Ayanna Pressley (D),
Jamie Raskin (D),
Lucille Roybal-Allard (D),
Jan Schakowsky (D),
Rashida Tlaib (D),
Peter Welch (D),
Last Action
Referred to the Subcommittee on Health. (on 01/25/2019)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/116th-congress/house-bill/465/all-info |
| BillText | https://www.congress.gov/116/bills/hr465/BILLS-116hr465ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr465/BILLS-116hr465ih.pdf.pdf |
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