HR 6501 114th Congress House Health 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

Prescription Drug and Medical Device Price Review Board Act of 2016

Introduced: December 8, 2016 Introduced by: DeLauro, Rosa L. Democratic · Connecticut See on congress.gov

Everywhere this bill has been 3 steps

Introduced

In committee

Reported out

Passed House

Passed Senate

To President

Became law

Dec 22, 2016

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Dec 8, 2016

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.

Dec 8, 2016

Introduced in House

Plain-English summary Congressional Research Service

Prescription Drug and Medical Device Price Review Board Act of 2016

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. 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.

What's happening now December 22, 2016

Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.

Committees of jurisdiction 4