To establish within the Department of Health and Human Services the Prescription Drug and Medical Device Price Review Board to regulate the prices of certain prescription drugs and medical devices, and for other purposes.
Ways and Means Committee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Prescription Drug and Medical Device Price Review Board Act of 2018 This bill establishes the Prescription Drug and Medical Device Price Review Board within the Food and Drug Administration. Each manufacturer of a prescription drug or medical device that is sold in the United States must submit to the board: each type of prescription drug and medical device that it sells in the United States, or in a country that is a member of the Organization for Economic Co-operation and Development; the price charged by the manufacturer for the drug or device; and the costs of the manufacturer to produce them. The board must establish a formula for determining whether the average manufacturer price of a prescription drug or medical device over an annual quarter is an excessive price. Manufacturers may not charge excessive prices. Individuals may petition the board to determine whether the price for a prescription drug or medical device is excessive. The board may subject violators to reduced patent terms, civil penalties, and increased Medicaid rebates payable to states. The bill amends the Internal Revenue Code to impose a tax on the sale of prescription drugs or medical devices that have excessive prices. The board must allow individuals to import from approved counties prescription drugs and devices that are comparable to prescription drugs and devices with excessive prices.
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Timeline
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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.
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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.
Health
Administrative law and regulatory proceduresAdministrative remediesAdvisory bodiesCivil actions and liabilityCongressional oversightConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEvidence and witnessesFood and Drug Administration (FDA)Government studies and investigationsHealth care costs and insuranceHealth technology, devices, suppliesInflation and pricesIntellectual propertyManufacturingMedicaidPrescription drugsSales and excise taxes
To establish within the Department of Health and Human Services the Prescription Drug and Medical Device Price Review Board to regulate the prices of certain prescription drugs and medical devices, and for other purposes.
USA115th CongressHR-5739| House
| Updated: 5/25/2018
Prescription Drug and Medical Device Price Review Board Act of 2018 This bill establishes the Prescription Drug and Medical Device Price Review Board within the Food and Drug Administration. Each manufacturer of a prescription drug or medical device that is sold in the United States must submit to the board: each type of prescription drug and medical device that it sells in the United States, or in a country that is a member of the Organization for Economic Co-operation and Development; the price charged by the manufacturer for the drug or device; and the costs of the manufacturer to produce them. The board must establish a formula for determining whether the average manufacturer price of a prescription drug or medical device over an annual quarter is an excessive price. Manufacturers may not charge excessive prices. Individuals may petition the board to determine whether the price for a prescription drug or medical device is excessive. The board may subject violators to reduced patent terms, civil penalties, and increased Medicaid rebates payable to states. The bill amends the Internal Revenue Code to impose a tax on the sale of prescription drugs or medical devices that have excessive prices. The board must allow individuals to import from approved counties prescription drugs and devices that are comparable to prescription drugs and devices with excessive prices.
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Timeline
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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.
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and 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.
Ways and Means Committee, Health Subcommittee, Judiciary Committee, Energy and Commerce Committee
Health
Introduced
In Committee
On Floor
Passed Chamber
Enacted
Administrative law and regulatory proceduresAdministrative remediesAdvisory bodiesCivil actions and liabilityCongressional oversightConsumer affairsDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEvidence and witnessesFood and Drug Administration (FDA)Government studies and investigationsHealth care costs and insuranceHealth technology, devices, suppliesInflation and pricesIntellectual propertyManufacturingMedicaidPrescription drugsSales and excise taxes