Prescription Drug and Medical Device Price Review Board Act of 2016

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.