Last week, four former FDA Commissioners – Robert M. Califf, Margaret B. Hamburg, Mark B. McClellan, and Andrew Von Eschenbach – wrote an open letter to members of Congress warning them about the risk of legalizing importation of drugs. The Washington Post outlines how these former FDA heads – who served in both Democrat and Republican administrations – advise against proposals to expose U.S. consumers to foreign medicines. The Commissioners write that a broad-based importation scheme would:
Harm patients and consumers and compromise the carefully constructed system that guards the safety of our nation’s medical products.
Robert Califf, in an interview with the Post, expressed concern that consumers would have no dependable way of knowing where drugs are coming from, what’s in them, or their safety overall. The letter warns that:
Global experience confirms that illicit, ineffective, or adulterated products are readily available on the open market and represent one of the most lucrative avenues of organized crime.
If the FDA were required to oversee this process, as proposed, a significant regulatory oversight system would be required. The former Commissioners question the likelihood of the agency getting the resources it would need to fulfill such a monumental task:
Obtaining sufficient resources and expertise to screen and verify the authenticity of every product destined for American consumers presents enormous challenges.
Studies on importation have forecasted the effects on access and savings in the U.S. to be small – potentially too small to ever reach the patient. The Commissioners write:
Any improved access and cost savings resulting from importation are likely to be minimal. Studies examining this issue have estimated that importation would likely have only a small, incremental effect on cost and access for drugs in the U.S. market; further, these small savings might not be passed on to patients, even if consumers are able to obtain a legitimate imported drug.
The letter also notes:
The current U.S. drug distribution system, as overseen by the FDA, ensures good manufacturing practices and the quality and security of an increasingly complex supply chain.
Read the full letter here.