6:30 AM
May 17, 2018
 |  BC Extra  |  Politics & Policy

FDA names, shames ‘anticompetitive’ drug companies

Editor's Note: This article was updated on May 17, 2018 at 2:25 PM PDT

FDA Commissioner Scott Gottlieb Thursday made public a list of 41 branded drug companies that generics manufacturers have accused of blocking access to drug samples to thwart development of competitive generic drugs.

The list includes complaints about branded drugmakers improperly using REMS requirements to restrict access to samples of branded drugs that are necessary to conduct FDA-required tests to demonstrate bioequivalence. In other instances, Gottlieb said branded drug companies may have placed restrictions in commercial agreements that limit the ability of distributors, wholesalers or specialty pharmacies to sell samples.

FDA reported 164 complaints dating back to at least 2007. Celgene Corp. (NASDAQ:CELG), Actelion Ltd., Gilead Sciences Inc. (NASDAQ:GILD) and Novartis AG (NYSE:NVS; SIX:NOVN) each are the subject of 11 or more complaints. Actelion is now part of Johnson & Johnson (NYSE:JNJ).

In a statement, Novartis said it disagrees with the inclusion of its products on the list. “It’s important to note the FDA has not independently investigated or confirmed the access limitations. To our knowledge, there are no restrictions preventing generic manufacturers from accessing these Novartis products and we have communicated that to generics companies that have contacted Novartis with similar requests.”

Celgene accumulated 31 complaints for using REMS Elements to Assure Safe Use (ETASU) requirements to block access to samples of Imnovid pomalidomide, Revlimid lenalidomide and Thalomid thalidomide.

Celgene said in a statement there were particular safety concerns for those drugs and that its “rigorous safety measures” were approved by FDA. It also said, “Generic versions of Thalomid and Revlimid are licensed to enter the market in coming years, and manufacturers have filed numerous ANDAs for generic versions of our medicines.”

The majority of complaints against Actelion and Gilead were for drugs with ETASUs, but 10 of 11 complaints against Novartis involved drugs that did not have an ETASU -- Afinitor everolimus, Exjade deferasirox and Tasigna nilotinib.

Actelion and Gilead did not respond to requests for comments.

In a statement, Gottlieb said that even in cases where a REMS program with an ETASU was in place, “generic drug developers should be able to secure samples of the product.” Generics drugmakers, Gottlieb said, can voluntarily submit bioequivalence testing protocols for FDA to evaluate. FDA can then contact the brand companies to clarify that the REMS does not preclude sale of the drugs to the generics company.

The agency has already sent 21 such safety determination letters.

FDA said it will turn the complaints over to the Federal Trade Commission (FTC). "We also encourage the generic drug developers to raise these cases with the FTC if they believe that anticompetitive conduct has taken place," Gottlieb said.

FDA will periodically update the public list of reference drug access inquiries, Gottlieb said.

The list includes the brand drug company, the drug product and the number of inquiries FDA has received. It also identifies products that FDA has certified are not subject to a REMS that would impede the sale of samples to generics drug developers.

Gottlieb said FDA is disclosing the information “because we believe greater transparency will help reduce unnecessary hurdles to generic drug development and approval.”

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Extra

Article Purchase

Purchase this article for limited one-time distribution and website posting

$750 USD