FDA posts lists of drugmakers it says may be ‘gaming’ the rules to thwart generic competition

FDA Commissioner Scott Gottlieb has initiated his attack on companies he says unfairly thwart generic competition with a list the FDA hopes will shame drugmakers into cooperation. (FDA)

FDA commissioner Scott Gottlieb has repeatedly promised to put an end the “gaming” of regulations by drugmakers that keep generics from getting to the market and so protect high drug prices.

Now the FDA is playing its own game, the shame game. On Thursday it posted a list of more than 50 drugs for which it says drugmakers reportedly refused to give generic drugmakers samples they need to develop copies that will eventually cut consumer prices. Some companies, like Celgene which tops the list, have turned back dozens of requests.

“At times, certain 'gaming' tactics have been used to delay generic competition. One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug,” the FDA said in its posting of “Reference Listed Drug (RLD) Access Inquiries.”

Such tactics, the FDA said, impedes the process, and “delays bringing affordable generic alternatives to patients in need."

Drug lobbying group PhRMA responded in a lengthy statement.

"While we must continue to foster a competitive marketplace, PhRMA is concerned that FDA’s release of the 'inquiries' it has received lacks proper context and conflates a number of divergent scenarios. It is important to differentiate between those products for which FDA has received complaints as opposed to those products for which it has received a request for a safety determination letter," the group said. "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."

Currently, the FDA’s only leverage is to send letters to the drugmaker asking them to make samples available, but it doesn’t have the authority to do more. Efforts to pass laws that would give it stronger tools have been foiled in Congress.

RELATED: New FDA commissioner Gottlieb unveils price-fighting strategies

Pharmacies and wholesalers are often the sources generic drugmakers turn to for samples, but some drugmakers make them difficult to tap, the FDA says. In some cases, drugmakers write contracts with wholesalers and pharmacies that prevent them from selling the branded drugs to generic companies.

In others, they rely on the Risk Evaluation and Mitigation Strategy (REMS) programs, which limit supplies to certain certified distributors because of risks associated with a medication. Drugmakers say that can’t sell them to generic companies because those competitors have not agreed to the REMS limits. But the FDA, which approves REMS programs, says it does not consider it a violation of the program for drugmakers to provide samples to generics makers.

The list includes some of the biggest companies in the business as well as some of the highest-priced drugs.

Celgene accounts for 31 inquiries from companies wanting samples of its blockbuster multiple myeloma drug Revlimid as well as its popular Pomalyst and Thalomid. In 2014, Celgene was sued by generics maker Mylan for thwarting its efforts to get samples. It has often cited REMS safety concerns to avoid giving them out.  

Celgene did not answer a request for comment, but a spokesman told The New York Times it has not kept competitors from getting access to its drugs.

“We have sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safety-related and business requirements,” he said.

After Celgene, Actelion, which is owned by Johnson & Johnson, is named 26 times for allegedly refusing 26 inquiries from competitors wanting to make copies of four of its drugs, including pulmonary arterial hypertension (PAH) drugs Traveler and Opsumit. Others include Gilead, Novartis and Pfizer.  

Actelion Pharmaceuticals Ltd., a Johnson & Johnson company, is accused of blocking access to four drugs.

The attacks on these “gaming” maneuvers are not limited to the FDA. Last year, a multiple myeloma patients sued Celgene over the 500% price jumps he had seen for the Revlimid he needs to keep him alive. In his class action suit, public policy specialist David Mitchell alleged the company illegally blocked generic competition that would have resulted in cheaper alternatives hitting the market.