In order to drive the manufacture of affordable generic drugs, the U.S. Food and Drug Administration is naming names of companies that have attempted to block competition.
In order to drive the manufacture of affordable generic drugs, the U.S.Food and Drug Administration is naming names of companies that have attempted to block competition.
Building on the momentum of President Donald Trump’s proposals to bring down the cost of prescription drugs, FDA Commissioner Scott Gottlieb announced some steps his agency will take to spur affordable drugs and improve access – including the prevention of branded companies gaming the system. To help improve generic competition and reduce the price of medicines, Gottlieb said the FDA said it will have to address some of the tactics banded drug companies use to protect their medications from generic competition, particularly the way branded companies prevent generic drugmakers from gaining access to samples of brand medicines.
Those samples are what generic drugmakers used to develop their products or use in head-to-head clinical trials. Gottlieb said the FDA has received more than 150 inquiries from generic drug developers who have requested assistance in obtaining samples from brand companies. Without them, alternative medicines cannot be developed.
“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 said.
One step is to publicly shame companies that block access. The FDA has created a public list of companies that have been blocking access. Some of the companies on the list include Roche, Novartis, Cubist Pharmaceuticals, Jazz Pharmaceuticals, BioMarin Pharmaceutical, Gilead Sciences, Inc. and more. In all, the FDA’s list includes more than 50 instances where companies have attempted to block generic manufacturers from getting samples. Several of the companies, such as Novartis, appear more than once on the list. Gottlieb noted that generic drugmakers need between 1,000 and 5,000 samples to complete their clinical processes.
Additionally, the FDA will post a list of the inquiries the regulatory agency has received from generic drug developers who report having trouble accessing testing samples. Through the increased transparency or shame, the FDA hopes that will reduce some of the hurdles generic drugmakers create. For example, the FDA has received 13 requests regarding samples of Celgene’s multiple myeloma drug Revlimid, as well as 10 requests for cancer drug Thalomid. Celgene isn’t the only company to be called out multiples times. Gilead Sciences was called out 10 times for its pulmonary arterial hypertension (PAH) treatment Letairis. The FDA has had 14 requests regarding Actelion Pharmaceuticals PAH drug Tracleer.
“… 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,” Gottlieb said.
There have been other tactics taken to limit challenges to branded drugs. Challenges to the Inter Partes Review process were popular, although in April the U.S. Supreme Court ruled the IPR is constitutional.
Before that ruling companies went to great lengths to avoid IPR challenges, perhaps most notably was Allergan’s attempt to circumvent patent laws by patents for Restasis to the Saint Regis Mohawk Tribe in New York. The company made the move last year as part of an attempt to take advantage of the Mohawk tribe’s sovereign immunity would shield the drug from IPR challenges to its patents on Restasis.
Gottlieb said the FDA will continue to look at ways it can address the access concerns. Gottlieb also noted that the FDA will continue to work with the Federal Trade Commission where there may be anticompetitive business practices. He added that the FDA will continue to strengthen its internal processes for handling inquiries related to problems generic drug developers report having in obtaining samples of brand products.
