The Food and Drug Administration is forming a work group to explore whether and how to temporarily import suitable substitutes for critical drugs with only one manufacturer, and no patents or exclusivities, when price increases or supply disruptions create significant barriers to patient access, FDA Commissioner Scott Gottlieb, M.D., announced today. The work group will examine issues such as the statutory and regulatory requirements relevant to developing and advancing such a policy. In other news, the FDA yesterday released a plan to speed biosimilar products to market and final guidance on labeling for biosimilar products. The plan focuses on streamlining and clarifying the product development and approval process; educating clinicians, patients and payers about biosimilars; and reducing anticompetitive behavior. While FDA has approved 11 biosimilars, only three are currently marketed in the U.S. According to a study the agency plans to release soon, Americans would have saved more than $4.5 billion in 2017 if all approved biosimilars were on the market, Gottlieb said.

Related News Articles

Headline
The Food and Drug Administration Friday released draft guidance on how drug developers can apply for the agency’s Competitive Generic Therapies designation.
Headline
Senate Finance Committee Ranking Member Ron Wyden, D-Ore., along with several other Democratic senators, yesterday introduced bills aimed at increasing…
Headline
Committee Chairman Richard Neal, D-Mass., and Ranking Member Kevin Brady, R-Texas, said they are committed to working on bipartisan reforms to lower drug…
Headline
The Department of Health and Human Services’ Office of the National Coordinator for Health Information Technology and Centers for Medicare…
Headline
The AHA, Federation of American Hospitals, and American Society of Health-System Pharmacists today convened a panel of experts on Capitol Hill to discuss how…
Headline
Nearly 50 health care and consumer groups, including the AHA, voiced their support for the Creating and Restoring Equal Access to Equivalent Samples Act as it…