Today, the FDA published a list of innovator companies for which FDA has received requests from generic sponsors to request that the Agency intercede in obtaining samples so the generic applicant can conduct the necessary bioequivalence (BE) testing to support ANDA approval. The FDA has taken this extraordinary approach to provide greater transparency regarding this issue. If ANDA sponsors cannot obtain samples to conduct BE testing, they cannot obtain ANDA approvals, which in turn limits competition and, as a result, adversely impacts drug prices.
FDA describes two scenarios where the gaming occurs:
- Where there is a restricted distribution system for the innovator products
- Where there is a REMS program in place that contains Elements to Assure Safe Use (ETASU)
The FDA announcement of the program (here) discusses how the process works in both scenarios and, most importantly, dispels the notion that there is a potential safety problem if applicants run BE tests on the specific products, as has been posited by certain people (see one example previously posted here). The FDA reviews all protocols for REMS products with ETASUs to assure that the same safety elements and protection for the subjects in the BE studies are comparable to those for patients taking the innovator drug. The FDA further notes that it will only allow the study to proceed if the firm has met all of its requirements and responds to any comments the FDA makes upon reviewing the initial protocol.
The FDA lists 52 different products for which it has received 164 individual requests. The top four products for which requests had been received are:
The FDA also identifies the company that is the innovator in its list; however, the Agency does not outline which (if any) requests have been fulfilled by the innovator.
Only time will tell if the list will have any impact on opening the way for ANDA sponsors to obtain the required samples for BE testing, but it certainly provides the public with a window into the magnitude of the problem.