Bill

Bill > HR465


US HR465

US HR465
Prescription Drug Price Relief Act of 2019


summary

Introduced
01/10/2019
In Committee
01/25/2019
Crossed Over
Passed
Dead
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)

Last Action

Referred to the Subcommittee on Health. (on 01/25/2019)

bill text


bill summary

Loading...

bill summary

Loading...
Loading...