May 9, 2017

Senate Committee on Health, Education,
  Labor, and Pensions
428 Dirksen Senate Office Building
Washington, D.C.  20510

Dear Senator,

On May 10, you are scheduled to mark-up S. 934, “The Food and Drug Administration (FDA) Reauthorization Act of 2017,” that will revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products.  It is our understanding amendments may be offered that will allow the importation of prescription drugs from Canada, and then after two years, from countries that are members of the Organisation for Economic Co-Operation and Development (OECD).  The amendments may also contain forced sale provisions.  On behalf of the more than 1 million members and supporters of the Council for Citizens Against Government Waste (CCAGW), I ask that you oppose all these amendments.

Allowing the indiscriminate importation of prescription drugs ignores the fact that the FDA has said it “cannot assure that such products have been properly manufactured and are effective;” therefore, “their use would present an unreasonable risk.”

Once a drug leaves the U.S., it also leaves the FDA’s closed distribution system, which was designed to ensure the safety and effectiveness of pharmaceuticals.  Importation opens the door to drug counterfeiting, diversion, and to crooked actors that could purchase large quantities of drugs and adulterate them.  FDA inspectors would be overwhelmed inspecting vast quantities of drugs imported into the U.S., even if Congress allows the agency to charge for certifying foreign distributors.

Legislation that adopts forced sale provisions ignores intellectual property rights and the extraordinary value prescription pharmaceuticals provide in improving people’s lives.  Provisions such as these, if enacted, could also cause shortages of pharmaceuticals for U.S. citizens.  For example, if a foreign supplier wanted to purchase large quantities of a drug, the manufacturer would be obliged to produce and sell the amount requested by the foreign entity, tying up production lines and schedules for U.S. buyers of that drug and other drugs.  In addition, legislation containing forced sale provisions would set a dangerous precedent for all innovators, not just biopharmaceutical companies.

Again, I ask that you oppose all amendments that contain importation and forced sale provisions.

Sincerely, 

Tom Schatz
President, CCAGW