The Food and Drug Administration on Thursday unveiled drugmakers that are limiting access to generic competition by denying access to their products.
The agency released a list of 52 brand name drugs to which generic companies are trying to get access in order to make a cheaper version. However, the generic companies have told the FDA that it is difficult to get access to the samples.
The new list of 52 drugs is part of a larger effort by the Trump administration to clamp down on high drug prices. Administration officials have decried drugmakers that “game” the patent system to deny generic companies access to samples needed for attaining FDA approval for a cheaper alternative. A generic company needs access to 1,500 to 5,000 units to prepare a study needed for FDA approval.
“The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process — leading to delays in bringing affordable generic alternatives to patients in need,” the agency said in a notice announcing the list.
The list comprises drugs for which the agency has received numerous inquiries from prospective generic drug applicants. The generic companies told the FDA that it wants to make a generic version of the brand name drug but can’t due to delays from the drug company.
A brand name drug company typically uses two avenues to deny samples. The first is through denying an application by citing an FDA safety strategy that restricts distribution to regular patients.
Another avenue is to make an agreement with a distributor to not sell products to a generic company asking for samples.
A hypertension drug called Tracleer manufactured by Actelion Pharmaceuticals received the highest number of generic drug inquiries with 14. Coming in second was the oral cancer drug Revlimid made by Celgene with 13.
FDA Commissioner Scott Gottlieb told reporters Tuesday that the goal of the new website was not to shame the drug makers, but to provide greater transparency.
