FDA to Form Workgroup to Study Drug Importation


WASHINGTON — Health and Human Services (HHS) Secretary Alex Azar on Thursday asked the FDA to develop a working group to consider whether importation of certain prescription drugs might help bring drug prices down.

“We look forward to working with [FDA] Commissioner [Scott] Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients,” Azar said in a statement. “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities … Safe, select avenues for importation could be one of the answers to these challenges.”

The statement also noted that the working group “will [only] consider drugs unprotected by patents or exclusivities, which will allow other manufacturers to introduce new competition.”

“Because the drugs being considered for importation are off-patent and have no exclusivity remaining, the proposals contemplated by the working group would not dilute intellectual property rights or affect incentives for innovation,” the statement continued. “Rather, they would provide a new avenue for competition to drive down prices for American patients.”

FDA Commissioner Scott Gottlieb, MD, spoke about a different aspect of importation: its potential to relieve shortages of drugs. “For certain critical medicines, where there are no blocking patents or exclusivities associated with the drugs, but where there is only a single manufacturer (sole-source), conditions may develop that create significant barriers to, and ultimately threaten, patient access,” he said in a statement. Such conditions could include dislocations in the supply chain or sudden, significant price increases that close off channels of availability.”

“These circumstances can leave patients without access to drugs they need,” he continued. “We want to examine whether — under these narrow conditions — the additional market competition from the short-term importation of foreign versions of the drug may complement the FDA’s current efforts, and help meet near-term patient need in the U.S. until new competition is able to enter the domestic market.”

Some issues that the FDA said the work group is being asked to consider include:

  • The statutory and regulatory requirements relevant to developing and advancing such a policy
  • How the FDA will define an access dislocation in these circumstances
  • How the FDA and HHS will evaluate the public health need for access to foreign-approved drugs in these situations
  • How the agency will assess the safety, effectiveness, and labeling of a foreign-approved drug that could be eligible for importation under such a policy
  • How the FDA will ensure that [it can] continue to protect patient safety through a secure drug supply chain and pursue enforcement against unsafe and illegal drug products
  • What additional steps the agency should take to continue to promote competition from additional FDA-approved versions of these sole-source generic drugs, to make sure that the government can achieve a supply of these medicines that is sustainable for the long run

At least one Republican senator sounded a note of cautious optimism about the working group. “I’m glad to see the Secretary explore new ways to increase competition and lower drug prices by importing prescription drugs, so long as the FDA approves the safety and effectiveness of those drugs and of the supply chains that carry them to American consumers,” Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor, & Pensions Committee, said in a statement.

“The FDA already approves the manufacture of prescription drugs in facilities overseas and it approves safe supply chains for those prescription drugs, so it makes sense to explore whether the FDA can do that in specific instances that increase competition and lower prices.”

2018-07-19T17:30:00-0400



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