- Celgene, Novartis and Gilead Sciences are among several dozen drugmakers called out by the Food and Drug Administration on Thursday for potentially impeding generic competition by blocking access to samples of their drugs.
- The FDA, in one of its more forceful steps to curb what it terms "gaming tactics" by pharma companies, published a list of 52 medicines that generic drugmakers have said are difficult to obtain samples of. Companies seeking to make a copy of a drug typically need several thousand units of the branded product to perform the studies required by the FDA to demonstrate bioequivalence.
- By making the list public, the agency hopes to push branded drugmakers into dropping potentially improper barriers that can forestall the entry of generic copies — one part of a larger effort by the Trump administration to lower the cost of drugs.
The FDA's new list is the latest step in the agency's "action plan" to spur greater competition in the prescription drug market.
"We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval," FDA Commissioner Scott Gottlieb said in a May 17 statement.
While Gottlieb has said the effort is not an attempt at "shaming" drugmakers, it could act as a deterrent for companies to use uncompetitive practices to slow generic competition. The list, which currently includes 39 drugmakers, will be updated semi-annually, the FDA said.
In some cases, branded drugmakers have allegedly used limited distribution programs known as Risk Evaluation and Mitigation Strategy (REMS) to limit the amount of samples generic drugmakers can obtain. REMS programs are required by the FDA for some drugs in order to help manage the product's risks, and usually mean those drugs are sold through specialized channels.
The FDA also says that pharma companies sometimes impose limits on wholesalers and other intermediaries that prevent the bulk sale of drugs to generic makers for testing.
The list published Thursday details 150 inquires received by the FDA from generic drugmakers asking for help in obtaining branded drug samples. Many large pharma companies made the list, as did, ironically enough, several major generic companies like Mylan and Teva Pharmaceutical Industries.
Celgene, in particular, stands out. The FDA has received 31 inquiries regarding the biotech's cancer drugs Revlimid (lenalidomide), Pomalyst (pomalidomide) and Thalomid (thalidomide). All three drugs are subject to REMS programs.
Major biopharmas most frequently the subject of access inquiries
|# of drugs on FDA list
|# of listed drugs with REMS
|# of inquiries received by FDA
|Actelion (now J&J)
When drugs are subject to a REMS program that restricts distribution, the FDA can notify a branded drugmaker through so-called "Safety Determination Letter" that sale of samples won't constitute a REMS violation. Twenty-one of these letters have been issued, the FDA said, but branded drugmakers aren't required to tell the FDA if they've subsequently made samples available after receiving a letter.
Notably, 27 of the drugs listed aren't distributed through a REMS program with elements to assure safe use.
The FDA said it regularly refers access inquiries it receives to the Federal Trade Commission, which handles investigation of anti-competitive business practices.