Friday, May 25, 2018

The Trump FDA publishes list of Reference Listed Drug (RLD) Access Inquiries

The FDA has posted a list of 50 drugs for which there have been Reference Listed Drug (RLD) Access Inquiries, of which two drugs (Ampyra and Tecfidera) have relation to multiple sclerosis.

This particular issue relates to samples needed by a potential generic maker to show, through testing, that its generic product is
bioequivalent to the proprietary drug [also termed the reference listed drug (RLD) ]. As the FDA notes

To obtain approval for a generic drug, the generic company needs to show, among other things, that its version of the product is bioequivalent to the RLD. This usually requires the generic company to conduct bioequivalence studies comparing its product to the RLD, and to retain samples of the RLD used in testing after a study is complete. To conduct these kinds of bioequivalence studies, the generic company needs to obtain samples (generally between 1,500 and 5,000 units) of the RLD.

The list of 50 drugs published by the FDA relates to instances in which the generic company has had difficulties obtaining the
samples needed for testing. The FDA notes

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 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.

As described in further detail below, these kinds of problems with generic access to necessary samples may occur when brand products are subject to limited distribution – whether the company has voluntarily adopted limitations on distribution, or the limitations have been imposed in connection with a Risk Evaluation and Mitigation Strategy (or REMS), a program that FDA implements for certain drugs to help ensure that their benefits outweigh their risks. In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need.

Neither Ampyra nor Tecfidera are stated to have a REMS issue.

See also the post from multiplesclerosisnewstoday
Two MS Medications Appear on FDA’s Shame List

Note also activities of Kyle Bass related to Ampyra and Tecfidera

The IPR petitions of Kyle Bass on Acorda/Ampyra denied by PTAB

A tale of two tribunals. Four Acorda multiple sclerosis patents go from --not invalid-- to invalid in less than one month!

PTAB declines to institute IPR against Biogen's US 8,399,514 related to the MS drug Tecfidera

Kyle Bass loses challenge to MS drug Tecfidera on US Patent 8,399,514 in IPR2015-01993

One might speculate that the Obama administration wss more "big pharma friendly" than is the Trump administration.


Post a Comment

<< Home