FDA Panel Begins Work on Drug Importation Proposal

A U.S. Food and Drug Administration (FDA) working group that was announced in July has now opened discussions about a policy of importing drugs from other countries under certain circumstances. The group aims to create a plan that would lower the prices of drugs for American patients, a top policy goal of the Trump administration.

Agency officials indicated that any proposed policy would be narrowly tailored and would only look at the importation of off-patent drugs to remedy drastic price increases. The working group has yet to define how “drastic” these price increases would need to be before drugs could be imported.

Pharmaceutical industry groups opposed the FDA’s plan, arguing that drug importation would undermine the safety requirements that protect U.S. patients. Pharmaceutical Research and Manufacturers of America stated that the plan would “[pose] a serious public health risk and [jeopardize] our secure medicine system,” while the Biotechnology Innovation Organization labelled it a “dangerous approach.”

The potential adoption of a drug importation policy represents a policy reversal for Health and Human Services Secretary Alex Azar. In May, Mr. Azar expressed doubt that importing drugs would help patients, referring to the idea as a “gimmick.”

Source: STAT News, August 20, 2018.