FDA Commissioner Puts Branded Companies on Notice

May 17, 2018

The FDA commissioner released a statement expressing the agency’s plan to address tactics used by pharma companies to delay generic-drug competition.

In a statement dated May 17, 2018, FDA Commissioner Scott Gottlieb, MD, discussed the steps the agency is taking to improve competition in the drug market and, therefore, improve the public’s access to affordable medications. One step in particular is addressing the actions some branded companies have been accused of taking to impede the development of generic versions of their products.

Gottlieb stated that some branded companies have made it difficult for generic-drug companies to purchase samples of their brand drugs, which generic-drug companies need to develop and conduct testing on generic versions of branded products.

“A generic-drug developer generally needs 1500 to 5000 units of the brand drug to perform what are often relatively straightforward studies for FDA approval. Without these samples, generic drug makers may not be able to develop generic alternatives. 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,” Gottlieb stated.

To create transparency, the agency is publishing a list of companies that have been suspected of blocking access to their products. Gottlieb stated that the agency has heard of some companies using Risk Evaluation and Mitigation (REMS) program requirements, such as REMS with Elements to Assure Safe Use (ETASU), as an excuse to refuse to sell samples or to make such a sale difficult for generic-drug competitors.

Another tactic some companies have been accused of taking is putting restrictions in their commercial contracts or agreements with drug distributors, wholesalers, or specialty pharmacies that limit the sale of samples from these distributors to generic-drug developers. The agency has received more than 150 requests from generic-drug developers asking for assistance in obtaining samples of brand drugs. A list of these requests has been posted on FDA’s website.

To combat these practices, FDA plans to determine if products do have a REMS program with ETASU that would cause limitation of sample sharing. If the agency determines the product does not have such a REMS program in place, it will inform the generic-drug developer that there are no FDA restrictions on the product. The agency will also inform the Federal Trade Commission about concerns raised by generic-drug developers. According to Gottlieb, “Many of the products that we have received inquiries about are not subject to REMS with ETASU.  This suggests that brand companies may be inappropriately using limited distribution to impede generic drug competition.”

Generic-drug developers, however, should be able to obtain samples of products that do have REMS with ETASU, Gottlieb stated. Generic-drug companies may submit their bioequivaqlence testing protocols to the agency. FDA will evaluate the protocols to ensure testing plans contain comparable safety protections. Once this is established, the generic-drug developer can request FDA send a letter to the brand company saying the REMS program does not prevent sales of product samples. 

“I want to be very clear: a path to securing samples of brand drugs for the purpose of generic-drug development should always be available. Even in the case of limited distribution programs such as those required by certain REMS, there should be a path forward for generic-drug development,” Gottlieb stated.

Source: FDA