FDA Updates List of Brand Name Companies Blocking Generic Applicants

Regulatory NewsRegulatory News | 12 February 2019 |  By 

Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition.

But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market.

As part of an effort to deter such a tactic, FDA recently created and updated a list of inquiries from prospective generic applicants indicating that they would like to develop a generic version of a marketed drug but are unable to obtain the necessary samples of the reference listed (or brand name) drug (RLD).


Generic companies seeking to win approval of new products must show that their product is bioequivalent to the RLD.

“This usually requires the generic company to conduct bioequivalence studies comparing its product to the RLD, and to retain samples of the RLD used in testing after a study is complete. To conduct these kinds of bioequivalence studies, the generic company needs to obtain samples (generally between 1,500 and 5,000 units) of the RLD,” FDA explains.

But occasionally, samples of the RLD are not available through normal distribution channels because the RLD sponsor limits distribution on its own initiative or because of a risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU).

For example, only a limited number of pharmacies might be willing or able to meet the specific pharmacy certification requirements in a REMS.

“Once such limitations are in place, we understand that some RLD sponsors (1) refuse to sell the product directly to the generic company (or impose terms on the sale that generic companies find burdensome or impossible to comply with), or (2) place limitations on the ability of pharmacies or wholesalers to sell samples to the generic companies for development purposes,” FDA notes.

Prospective generic applicants can request that FDA review their bioequivalence study protocols to assess whether they contain safety protections comparable to those in the applicable REMS for the RLD.

If FDA determines that they do, FDA will notify the prospective generic applicant of this determination by letter.
The prospective generic applicant then can request that FDA send a second letter, known as the Safety Determination Letter, directly to the RLD sponsor stating that FDA will not consider providing product to the particular generic applicant to be a violation of the REMS for the RLD.

Updated List

Updated on a semi-annual basis, FDA has created a list that reflects the RLD access inquiries the agency has received from prospective generic applicants about marketed RLD products.

The list ranges from 14 inquiries for Actelion Pharmaceuticals’ Tracleer (bosentan) to 13 inquiries related to Celgene’s Revlimid (lenalidomide) to 10 inquiries for Gilead’s Letairis (ambrisentan).

But FDA also notes that it has not “independently investigated or confirmed the access limitations described in the inquiries received.”

Reference Listed Drug (RLD) Access Inquiries


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Tags: generics, REMS, RLD

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