Senate HELP Asks Do We Want to Bypass the FDA Gold-Standard of Drug Approvals with Importation?

On October 17, 2017, the Senate Committee on Health, Education, Labor and Pensions invited representatives from PhRMA, the American Pharmacists Association, the Association for Accessible Medicines, the Healthcare Distribution Alliance, and the Pharmaceutical Care Management Association to testify and inform the Senate on what they see as rising pharmaceutical drug costs.

Senator Lamar Alexander of Tennessee at one point focused the hearing on drug importation as a solution asking, “With the exception of drugs compounded in pharmacies, each drug sold -- pharmaceutical drug sold in the united states requires a careful review by the food and drug administration before that drug can be sold in the United States. We call that the FDA gold standard. There are 4.4 billion prescriptions a year. Most of us when we go into our local pharmacy or doctor's office don't worry about the safety of those prescriptions because we rely on the FDA gold standard. Sometimes the cost of drugs come up, there are proposals that we should import drugs from other countries and side-step the careful FDA approval and review of each drug sold in the United States. I’d like to ask each of you starting with Mr. Menighan and going across whether you agree we should allow drugs approved by other countries to be sold in the United States, without careful review and approval of each drug by the Food and Drug Administration?”

Every panelist unequivocally stated their opposition to drug importation proposals, citing the danger to patients an unregulated drug supply chain would expose them to. Three, in particular, made cogent arguments on behalf of patient safety and drug accessibility.

Elizabeth Gallenagh, Senior Vice President and General Counsel for the Healthcare Distribution Alliance, pointed out the years of work her organization has done to safeguard the U.S. pharmaceutical supply and stated that “we would absolutely oppose importation, as it would threaten patient safety in this country.”

Chester "Chip" Davis, Jr., President and CEO of the Association for Accessible Medicines, the generic medication manufacturers in the United States, explained that generic drugs are almost uniformly cheaper in the United States than in other countries.

However Thomas Menighan, President of the American Pharmacists Association, explained most succinctly why any drug importation proposals are counter to the health and wellbeing of American patients:

“While ApHA appreciates any efforts to address patients’ medication costs, we don’t believe importation is the solution to the complex issue of drug pricing. Broadened importation of non-FDA meds threatens patient safety, directly conflicts with congressional efforts to increase the integrity and security of the supply chain and drug supply chain security act, disrupts continuity of care and value-based payment and delivery. We're concerned savings, if any, will be short-term, and importation will instead, result in long-term costs to patients.”

Watch the Senate Health Committee hearing here.