Administrative State, Regulatory Reform, and Antitrust Subcommittee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Prescription Drug Price Relief Act of 2021 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 development 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Administrative remediesAsiaBusiness recordsCanadaCivil actions and liabilityCompetition and antitrustDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEuropeFranceGermanyGovernment information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth information and medical recordsInflation and pricesIntellectual propertyJapanLicensing and registrationsManufacturingMarketing and advertisingMedical researchPrescription drugsResearch and developmentUnited Kingdom
Prescription Drug Price Relief Act of 2021
USA117th CongressHR-2148| House
| Updated: 10/19/2021
Prescription Drug Price Relief Act of 2021 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 development 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.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Administrative remediesAsiaBusiness recordsCanadaCivil actions and liabilityCompetition and antitrustDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEuropeFranceGermanyGovernment information and archivesGovernment studies and investigationsHealth care costs and insuranceHealth information and medical recordsInflation and pricesIntellectual propertyJapanLicensing and registrationsManufacturingMarketing and advertisingMedical researchPrescription drugsResearch and developmentUnited Kingdom