WASHINGTON, D.C. – In a letter today, U.S. Senator Angus King (I-Maine) urged Food and Drug Administration (FDA) Commissioner Margaret Hamburg to rethink a newly-proposed regulation that provides FDA with the authority to seize and destroy certain prescription drugs that patients purchased from outside the country.

The letter, which was also signed by Senators David Vitter (R-La.), Chuck Grassley (R-Iowa), and Dean Heller (R-Nev.), requests that the FDA modify the proposed rule to require that patients be notified at least six months in advance that their drugs may be destroyed and also asks that the final rule be implemented over time so the FDA can focus their resources on the destruction of narcotics and other controlled substances.

“This proposed regulation constitutes a potential health threat to hundreds of thousands of Americans who receive their affordable drugs from safe, licensed and legal pharmacies in Canada,” the Senators wrote.

The text of the letter is below:

June 9, 2014

Dr. Margaret Hamburg

Office of the Commissioner

U.S. Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner:

We are writing to express our serious concerns with draft FDA regulation, 21 CFR Part 1 (Docket No. FDA-2014-N-0504) and urge significant changes to the proposal, which allows for sweeping and arbitrary seizure and destruction of prescription drugs valued at $2,500 or less.

This proposed regulation constitutes a potential health threat to hundreds of thousands of Americans who receive their affordable drugs from safe, licensed and legal pharmacies in Canada.

Millions of low-income individuals and seniors living on a fixed income cannot afford the high cost of their prescription drugs as evidenced by a 2013 Commonwealth Fund study that indicated 50 million Americans did not fill a prescription due to high costs in 2012.

We request that the final regulation contain a requirement that patients be notified that their drugs could be destroyed at least six months in advance of their medication being denied to them. Additionally, in this day of limited federal resources we request that the regulations be phased in over two, five-year periods. In phase one, the FDA should focus limited resources on the destruction of narcotics and other controlled substances being imported into the U.S. The second phase then could allow for the full implementation of the regulation as prescribed by law. This would allow the FDA to continue to make closing dangerous rogue pharmacies a priority while allowing consumers who purchase affordable medications from Canada time to identify alternative sources.

We must continue to address the needs of our most vulnerable population and we urge you to incorporate our recommendations into the proposed regulation. Thank you for your time and consideration in this most important matter.

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