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# FDA Mulls European Drug Supplies for Generic Testing: Gottlieb
- URL: https://www.fdaweb.com/fda-mulls-european-drug-supplies-for-generic-testing-gottlieb/
- Published: 2018-02-16T12:00:00.000Z
- Updated: 2026-09-14T23:23:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140781

As a means to help bring down rising drug costs, FDA commissioner **Scott Gottlieb** says he is stepping up pressure against brand drug makers and their tactics to block generic drug market entries. In a 2/15 [interview](https://khn.org/news/fda-head-vows-to-tackle-high-drug-prices-and-drugmakers-gaming-the-system/?ref=fdaweb.com) with *Kaiser Health News*, the agency head expressed his frustration with brand drug makers gaming the system. Specifically, he said FDA is exploring an alternative path for potential generic product makers to obtain brand drug supplies, which are needed to conduct required bioequivalence and other testing, when brand makers block their access.

“\[Brands\] are adopting all kinds of commercial restrictions with specialty pharma distributors and wholesalers” to prevent sales to generic companies, Gottlieb said, adding that not every branded company is using the tactic, but it is “going on across the board.” He said the agency is currently exploring whether generics makers could buy the drugs they need from European markets without having to do additional work (bridging studies) to prove they are the same, noting that many American and European drug versions are often manufactured in the same plants.

“I have lawyers now looking at this,” Gottlieb said. FDA has been exploring the issue for a couple of months, he said, and he thinks it may be “hard for us to get there without legislation, but we’re not done yet looking at this; we’re still pressing on this.”

In the interview, Gottlieb also discussed a new proposal outlined in the recently released fiscal year 2018 budget plan ([see story](https://www.fdaweb.com/13-boost-in-fda-budget-proposed-by-trump/)) to “ensure that first-to-file generic applicants who have been awarded a 180-day exclusivity period do not unreasonably and indefinitely block subsequent generics from entering the market beyond the exclusivity period.” Under the proposal, when a first-to-file generic application is not approved due to deficiencies, FDA would be able to tentatively approve a subsequent generic application, which would start the 180-day exclusivity clock. “Triggering the start of the 180 day-exclusivity period for first-to-file applicants who ‘park’ their exclusivity would speed delivery of generic drugs and provide substantial cost savings to American consumers,” the plan says.