FDA Begins Naming Firms Accused of Stalling Generic Competitors

Regulatory NewsRegulatory News | 17 May 2018 |  By 

Months after Food and Drug Administration (FDA) Commissioner Scott Gottlieb called on drugmakers to “end the shenanigans” that delay generic competition, the agency has published a list of companies that may be restricting access to samples of their products to generic firms.
“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,” Gottlieb said.
The move follows announcements made by President Donald Trump and Secretary of Health and Human Services Alex Azar outlining plans to reduce the cost of prescription drugs by increasing competition and cutting regulation.
According to FDA, generic drugmakers typically need between 1,500-5,000 units of a reference listed drug (RLD) to conduct the bioequivalence studies needed to support the approval of an abbreviated new drug application (ANDA).
But Gottlieb said that companies often resort to anticompetitive tactics to keep generic drugmakers from accessing these samples.
In some cases, branded drugmakers cite restricted distribution requirements present in the FDA-mandated risk evaluation and mitigation strategy (REMS) for their products as a reason they cannot sell samples to generic firms. In other cases, companies have voluntarily imposed distribution restrictions on pharmacies and distributors that prevent samples from being sold to generic firms.
When a REMS is cited as a reason for not being able to sell samples to a generic drugmaker, the generic firm can request for FDA to send a “safety determination letter” to the sponsor of the branded drug informing them that providing the samples would not violate the terms of the REMS.
RLD Access Inquiry List
The list published today by FDA currently includes 52 branded drugs that FDA has received access inquiries about from generic drugmakers.
Some of those drugs, such as Celgene’s Thalomid (thalidomide) and Revlimid (lenalidomide) and Actelion’s Tracleer (bosentan) are the subject of 10 or more inquiries.
Companies with the most complaints lodged against them by generic drugmakers include Celgene with 31 inquiries, Actelion with 26 inquiries and Gilead and Novartis with 11 inquiries each.
Just under half of the drugs present on the list are subject to a REMS with an elements to assure safe use (ETASU) that impacts distribution. Of those, FDA has issued safety determination letters to 16 of the reference drug sponsors.
While some have said the list is meant to shame branded drugmakers into easing access to their products for generic testing purposes, the move stops short of Gottlieb’s initial call to release the safety determination letters themselves to the public.
Aaron Kesselheim, associate professor of medicine at Harvard Medical School, told Focus that the release of the letters themselves would be more informative to the public than merely a list of the firms accused of blocking access to samples.
But Kesselheim also said that such moves may not be enough to change drugmakers’ behavior.
“Ultimately, it may require real action, such as making the practice illegal if possible by regulatory action,” he said, noting that FDA could also take steps to address other tactics used by drugmakers to stall generic competition such as product hopping.
FDA, Gottlieb Statement


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