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FDA ‘names and shames’ generic-blocking pharma companies

Celgene and Actelion top the list of offenders

The FDA has followed through on plans to identify pharma companies they believe have tried to block generic copies of their brands, for example by making it hard to acquire medicines for bioequivalence studies.

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.”

It makes for uncomfortable reading for some drugmakers: Celgene heads the list accounting for 31 of the 150-plus inquiries received by the FDA, relating primarily to myeloma therapies Revlimid and Pomalyst, followed by Actelion with 26 inquiries mainly for pulmonary artery hypertension drugs Tracleer and Opsumit. Novartis and Gilead also feature prominently with inquiries in the double figures.


FDA Commissioner Scott Gottlieb said in a statement that a generic drug developer “generally needs 1,500 to 5,000 units of the brand drug to perform what are often relatively straightforward studies for FDA approval.”

“Without these samples, generic drugmakers may not be able to develop generic alternatives,” he continued, noting that the problem seems to be particularly acute when the medicine in question is subject to limited distribution such as those which have been approved with a Risk Evaluation and Mitigation Strategy (REMS).

“We have heard that some drug makers have either refused to sell samples of products with REMS…impacting distribution to potential generic competitors, or have imposed conditions on the sale of such samples that generic companies find hard or impossible to comply with,” said the Commissioner.

REMS should be no impediment to securing samples, said Gottlieb, and the FDA has already sent 21 “safety determination letters” to brand owners making it clear that they must not impose such blocks. More seriously, the agency has also discovered that in many cases there is in fact no REMS programme in place at all. When that occurs, it notifies Federal Trade Commission (FTC) to investigate further under anti-competition laws.

The obstructive practices were referred to as ‘gaming’ in President Trump’s blueprint document which was unveiled last Friday and aims to cut medicine prices. These practices include examples in which brand companies impose restrictions in contracts with wholesale distributors or specialist pharmacies to impede the sale of drugs to generic developers.


“We’re taking these steps today because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval,” said Gottlieb.

Responding to the action, industry body the Pharmaceutical Research and Manufacturers of America (PhRMA) said it is “concerned that FDA’s release of the ‘inquiries’ it has received lacks proper context and conflates a number of divergent scenarios.”

“It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter,” it goes on.

“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.”

Article by
Phil Taylor

17th May 2018

From: Marketing



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