FDA, Politics

Who’s delaying generic competition? FDA publishes a long list of drugmakers they say gamed the system

Making good on the administration’s promise to name and shame drugmakers  — most recently reiterated in HHS Secretary Alex Azar’s speech Monday — the FDA has released a list of them, all accused of unfairly withholding reference samples of their drugs in order to block generic entry.

Scott Gottlieb

On a list of 52 reference listed drugs (RLDs) posted Thursday, the FDA detailed the names and developers of each one, alongside the number of access inquiries the agency has received in relation to them. The publication of this list, which you can see below, is part of the FDA’s drug competition action plan as it commits to address and improve “transparency about this and other gaming tactics that delay the generic competition Congress intended.” Without sample drugs, generic companies cannot conduct bioequivalence studies — a fundamental part of any ANDA.

Access inquiries are submitted when a company expressing an intent to develop a generic drug is unable to obtain necessary samples of the original. Thus, the list is essentially a document of allegations — the FDA has not independently investigated or confirmed the access limitations described in the inquiries.

The FDA made a point to distinguish between those drugs shielded under the Risk Evaluation and Mitigation Strategy (REMS) program and cases where drugmakers used contractual clauses to preclude distributors, wholesalers or specialty pharmacies from selling to would-be competitors.

Roughly half of the drugs cited falls under the purview of REMS with elements to assure safe use (ETASU), which branded drugmakers could employ in a number of ways to block access. In those cases, the FDA points out, it has a process in place whereby the RLD sponsors could provide their products to generic applicants without violating the REMS. Given it finds the company’s safety protections satisfactory, that authorization would come in the form of a safety determination letter.

According to the list, nine out of the 52 drugs have been involved in such a letter, with the earliest one issued in 2009.

Alex Azar

Actelion’s Tracleer, the pioneering pulmonary artery hypertension drug that now belongs to J&J, tops the list with 14 access inquiries. Together with Novartis, the former Swiss biotech has the highest number of products — four — that generic competitors have claimed to have trouble accessing. The list was not short of big names, featuring Celgene (for Revlimid, Polymast and Talomid), GlaxoSmithKline (Promacta), Roche (Accutane) and generic giant Teva (Claravis).

In response, industry group PhRMA said it’s concerned that the list lacks “proper context” and “conflates” several issues. There is an important difference, for instance, between products mentioned in complaints and those for which the FDA has received a request for a safety determination letter,

“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.

Celgene, whose Revlimid got 13 access inquiries, told Reuters that all three of its products on the FDA list all require rigorous safety controls due to the severity of their side effects, and that two of them already have generic versions set to enter the market in coming years.

Going after these tactics has been a rallying point for FDA Commission Scott Gottlieb, who pointedly called on branded name drug companies to “end the shenanigans” at a panel a few months ago. Gottlieb was backed up by Azar during his Monday speech, in which he called for shaming drug makers that refuse to make samples available for generic manufacturers to use for their development work.

We might see how effective the strategy is when the list gets updated in half a year.


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