HHS May Allow Limited Importation of Prescription Drugs

The U.S. Department of Health and Human Services (HHS) has announced that it is forming a working group to investigate the importation of prescription drugs from foreign countries. The plan, though in its early stages, is the latest strategy floated by the Trump administration as part of its effort to lower drug costs.

The working group will study drug importation as a policy and will focus on drugs that are unavailable in the U.S. “I believe we can do it in a way that is safe, effective, [leads] to results, and … preserves innovation,” HHS Secretary Alex Azar said, telling U.S. Food and Drug Administration Commissioner Scott Gottlieb, MD, “Make it happen and make it happen quickly.”

While President Donald Trump campaigned on the promise to lower prescription-drug prices by importing medications from abroad, the creation of a working group to study the issue represents a policy reversal for Sec. Azar, who had previously opposed the measure. In announcing the plan, however, he pointed to cases of exorbitant rises in drug costs in recent years.

“We are open to all potential solutions – assuming they are effective, safe for patients, and respect choice, innovation, and access,” Sec. Azar said in a statement.

The move faced pushback from pharmaceutical industry trade groups, including the Pharmaceutical Research and Manufacturers of America, the Biotechnology Innovation Organization, and the Association for Accessible Medicines, who argue that imported drugs could jeopardize patient safety without providing real savings.

Seeking to allay these concerns, Commissioner Gottlieb emphasized that policy changes would be “narrowly tailored,” and that it would not open up drug importation to the extent that some legislative proposals support. “Any policy that involves the importation of drugs would be temporary until adequate competition enters these categories,” he said.

Source: STAT News, July 29, 2018.