Prescription Drug and Medical Device Price Review Board Act of 2018

Bill: 115-hr-5739
Sponsor: Rep. DeLauro, Rosa L. [D-CT-3]
Introduced: 2018-05-09 in the House
Policy area: Health
Subjects: Administrative law and regulatory procedures
Administrative remedies
Advisory bodies
Civil actions and liability
Congressional oversight
Consumer affairs
Department of Health and Human Services
Drug safety, medical device, and laboratory regulation
Evidence and witnesses
Food and Drug Administration (FDA)
Government studies and investigations
Health care costs and insurance
Health technology, devices, supplies
Inflation and prices
Intellectual property
Manufacturing
Medicaid
Prescription drugs
Sales and excise taxes

Summary:
action_date: 2018-05-09
text: 

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.


Legislative actions:
action_date: 2018-05-25
text: Referred to the Subcommittee on Health.
action_date: 2018-05-09
text: 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.
action_date: 2018-05-09
text: 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.
action_date: 2018-05-09
text: 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.
action_date: 2018-05-09
text: Introduced in House
action_date: 2018-05-09
text: Introduced in House