To Energy and Commerce Committee: Oppose Drug Importation or Price Control Amendments

June 7, 2017

U.S. House of Representatives
Committee on Energy and Commerce
2125 Rayburn House Office Building
Washington, D.C.  20515

Dear Representative,

On June 7, you are scheduled to mark-up several bills, including the Food and Drug Administration (FDA) Reauthorization Act of 2017, which will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products.  It is our understanding that an amendment may be offered that would allow drug importation.  On behalf of the more than 1.2 million members and supporters of the Council for Citizens Against Government Waste (CCAGW), I ask that you oppose any amendment that would allow drug importation or any form of price controls.

Once a drug leaves the United States, it also leaves the FDA closed distribution system, which was designed to ensure the safety and effectiveness of pharmaceuticals.  Importation opens the door to crooked actors that could purchase large quantities of drugs and adulterate them, perhaps by re-manufacturing them with some sort of filler to increase the amount of product they could sell, while lowering potency at the same time.  It would also encourage drug counterfeiting and diversion.  Even if the amendment allows the FDA to charge fees to certify foreign sellers, the agency would still be overwhelmed by the inspection of vast quantities of imported drugs.  Further, the FDA has stated clearly it cannot guarantee the safety of such drugs. 

Allowing drug importation would also import price controls, which are utilized in Canada and the European Union.  Because the United States does not employ price controls and respects intellectual property and the extraordinary value pharmaceuticals provide in improving people’s lives, the nation continues to lead the world in pharmaceutical research and development.  According to the Winter 2016 issue of R&D Magazine, the U.S. dominates the world with 56 percent of pharmaceutical/biotech research.  The closest competitor is Germany at 16 percent, the United Kingdom at 7 percent, and Japan at 5 percent.  Canada is not even on the list.

Importation bills also ignore the fact that foreign countries may not want to sell their drug supplies to Americans, since that could lead to shortages for their citizens; or that pharmaceutical firms would ship a greater supply of drugs than a country’s population would warrant.

The best way to lower drug prices is to encourage competition.  Reauthorizing prescription drug user fees will help to accomplish that objective by encouraging faster drug approvals, both in the research-based and generic pharmaceutical marketplace.  It will also do so without importing price controls or drugs that may be ineffective and dangerous.  Again, I urge you to reject any amendment that would adopt pharmaceutical importation.

Sincerely,

Tom Schatz
President, CCAGW

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