Israel’s Teva on FDA blacklist of drugmakers creating barriers to competition
Agency says ‘increased transparency will help reduce unnecessary hurdles to generic drug development and approval’
Add ToI as a Preferred Source on GoogleShoshanna Solomon was The Times of Israel's Startups and Business reporter
The US Food and Drug Administration has unveiled a list of drugmakers that are setting up “unnecessary hurdles” that make it harder for generic competitors to get a bite of their market share, by denying them access to samples of their branded drugs to develop a generic version of the product. Israeli drugmaker Teva Pharmaceutical Industries Ltd. is one of the companies listed, along with other international pharma giants including Bayer Healthcare Pharmaceuticals Ltd., Novartis Pharmaceuticals Corp., Mylan Pharmaceuticals Corp. and Pfizer Pharmaceuticals Production Corp. Ltd.
The FDA, which is the federal agency of the US Department of Health and Human Services, said that one of its highest priorities “is advancing policies that increase competition” to help make drugs more affordable and improve access.
Thus, the FDA is looking to address tactics used by makers of branded drugs to forestall the expected generic entry of the drugs, by creating obstacles for generic developers in purchasing samples of their drugs.
“Today, we’re making public a list of companies that have potentially been blocking access to the samples of their branded products. We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval,” the FDA said in a statement on May 17.
Generic drug developers need samples of the branded drugs to develop their own generic product version or to conduct testing to demonstrate that their product is the bioequivalent of the brand drug, in order to get FDA approval.
A generic drug developer generally needs 1,500 to 5,000 units of the branded drug to do the studies, ahead of the FDA approval.
“Without these samples, generic drug makers may not be able to develop generic alternatives,” the statement said. “Yet, the FDA has heard that some brand companies will adopt tactics to make it hard for the generic companies to purchase these brand drugs at a fair value and in the open marketplace. The FDA is taking new steps to address this issue.”
Teva was named among the list of companies for creating obstacles to access samples of its Claravis drug, to treat severe acne.
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