FDA calls out drugmakers to promote greater generic competition

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To contact the reporters on this story: Cynthia Koons in NY at ckoons@bloomberg.net, Anna Edney in Washington at aedney@bloomberg.net. The news and stories that matter, delivered weekday mornings.

The regulator says it has collated inquiries from generic drug developers wanting to obtain supplies of reference drugs for generic studies, and provided a list of companies "that have potentially been blocking access to the samples of their branded products".

"In general, generic drug developers need the samples of the brand drug to develop their generic product and/or to conduct testing to show that their product is bioequivalent to the brand drug for FDA approval", he explained.

Scott Gottlieb denied he was trying to shame pharmaceutical companies but said the public discussion can make things a little more transparent. That includes moving doctor-administered drugs from Medicare Part B, where there is no negotiation on price, to Part D, where private plans can secure discounts. Developing a generic version of the drug generally requires as many as 5,000 samples, the FDA said. Even when they are, the agency wants generic companies to have access. Biogen was reported to the FDA by a generic-producing company for issues in acquiring samples of Tecfidera, the company's multiple sclerosis drug.

Such tactics, the FDA said, impedes the process, and "delays bringing affordable generic alternatives to patients in need".

Some of the drugs on the list have had only a handful of inquiries but Letairis, a drug sold by Gilead Sciences to treat a condition called pulmonary arterial hypertension, got 10 queries. On the current list, the highest number of requests from generic firms - 14 - was for samples of bosentan (Tracleer) made by Actelion Pharmaceuticals, followed by lenalidomide (Revlimid) made by Celgene (13 inquiries).

The drug company lobby group PhRMA said the FDA list mixes up all sorts of situations.

"While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA's release of the "inquiries" it has received lacks proper context and conflates a number of divergent scenarios".

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"Additional context is essential and we believe the Agency should give innovator companies the opportunity to submit their appropriately redacted response to the recipient of a safety determination letter", a spokesperson said in an email to STAT.

Revlimid has a REMS program and the FDA has sent Celgene four safety determination letters.

Groups working to lower drug prices welcomed the FDA'S move.

"This is a great day for for patients, since the administration's list makes the definitive case why brand-name drug companies must stop blocking generic competition", said Allen Goldberg, vice president of communications for the Association of Accessible Medicines.

"All the scheming and exploitation of our government's rules means more profits for corporations at the expense of everyday Americans struggling to get the life-saving medicines they need", said Tahir Amin, co-founder of Initiative for Medicines, Access & Knowledge.

The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group for brand-name drugmakers, pointed out in response that more than 90% of prescriptions filled in the US are for generics.

Novartis spokesman Eric Althoff said the company disagrees with the inclusion of its medicines on the list and, as a maker of generic drugs through its Sandoz unit, supports the development of generic products.

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