June 9, 2014
Dr. Margaret Hamburg
Office of the Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
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.
Angus S. King, Jr.