FDA publishes list of drugmakers who may have blocked access to product samples to delay generic competition

The FDA on Thursday released a list of drugmakers that have "potentially" been blocking access to samples of their branded products requested by generics companies. The list, which covers 52 drugs, includes Celgene, for which the agency received 31 total inquiries for Revlimid (lenalidomide), Thalomid (thalidomide) and Pomalyst (pomalidomide). Other drugmakers named in the list, which is expected to be updated twice annually, include Johnson & Johnson's Actelion unit regarding Opsumit (macitentan) and Tracleer (bosentan), Novartis for Exjade (deferasirox) and Tasigna (nilotinib), as well as Gilead Sciences in relation to Letairis (ambrisentan).

The FDA noted that it has received a total of 152 inquiries from companies requesting assistance in obtaining the listed treatments, with the agency sending 21 letters to drugmakers to support their requests. Earlier this week, FDA Commissioner Scott Gottlieb Gottlieb argued "I'm not looking to shame drug companies," adding "I'm looking to bring transparency around what I think are reasonable public health questions." The commissioner stated "we're especially focused on addressing tactics we sometimes hear of branded companies pursuing as a way to forestall expected generic entry."  

Gottlieb specifically explained that in some cases, drugmakers cite risk evaluation and mitigation strategies (REMS) as a barrier to providing samples to potential generic competitors. The commissioner noted that drugmakers have also enacted restrictions blocking drug distributors, wholesalers or specialty pharmacies from selling samples to generics companies. Gottlieb said "a path to securing samples of brand drugs for the purpose of generic drug development should always be available," even in the case of limited distribution programmes, such as those required by certain REMS.

The FDA cautioned that "brand companies generally do not inform the agency whether they have made samples" of a drug available after receiving communication from the regulator that the drug can be safely made available for testing, suggesting that some information on the list, which also includes AstraZeneca, Bayer and Biogen, could be out of date.

In response to publication of the list, Biogen said it complies with requests from generic companies for samples, while Bayer indicated that it is the drugmaker's practice to "provide samples upon request, in full accordance with applicable laws and regulations." Meanwhile, AstraZeneca said it was unaware of any outstanding requests for samples of Brilinta (ticagrelor) by any generic manufacturers, despite the product appearing on the FDA's list.

The news comes as part of efforts by the administration of President Donald Trump to increase competition and reduce drug prices in the US. Earlier this week, Health and Human Services Secretary Alex Azar said the administration is considering a proposal that would expand the ability of Medicare to negotiate drug prices with pharmaceutical companies (for related analysis, see ViewPoints: Score one for the home team- pharma off the hook again after drug pricing comments).

Meanwhile, the US Congress is currently considering a measure, named the Creates Act, which would provide generic drugmakers the ability to pursue legal action against companies suspected of delaying access to testing samples. The legislation has been opposed by the Pharmaceutical Research and Manufacturers of America, which contends the bill would only benefit trial lawyers.

For additional analysis, read ViewPoints: FDA trying the 'name and shame' approach on REMS reform.

To read more Top Story articles, click here.