FDA updates list of inquiries from prospective generic drug applicants about RLD access

FDA updates list of inquiries from prospective generic drug applicants about RLD access

As announced in May 2018, FDA has received numerous inquiries from prospective generic drug applicants who indicate being interested in developing a generic drug product but who report being unable to obtain samples of the reference listed drug (RLD) needed to support their applications because of limitations on distribution of the RLD. These inquiries include both drug products that are subject to Risk Evaluation and Mitigation Strategies (REMS) impacting distribution and products that are not subject to a REMS impacting distribution, but for which RLD sponsors may have imposed voluntary distribution restrictions.

To provide transparency regarding these inquiries, the agency published a list identifying all drug products about which FDA has received an RLD access inquiry, along with details including the name of the applicable RLD sponsor, the number of RLD access inquiries FDA has received about the product, and whether FDA has communicated directly to the RLD sponsor at the generic company’s request (as further explained on the website itself, such a communication is voluntary and is only an option for certain products). The reports in the inquiries have not been independently investigated or confirmed by FDA.

As stated on the webpage, FDA intends to update this list on a semi-annual basis. This is the second such update.

The agency published this list as part of the Drug Competition Action Plan (DCAP), which seeks to expand access to safe, high quality, effective generic medicines that can help consumers lower their health care costs. Of note, FDA has recently created a DCAP web page to collect all related agency efforts in one easily accessible place.