Eric H Yecies is a attorney in Holland & Knight's New York office
On May 17, 2018, the Food and Drug Administration (FDA) posted a new list targeting pharmaceutical companies that, in the FDA's view, have used "certain 'gaming' tactics to delay generic competition." The list is intended to "improv[e] transparency about this and other gaming tactics that delay the generic competition Congress intended."
In particular, the FDA seeks to discourage branded pharmaceutical companies from preventing potential generic applicants from obtaining samples of certain brand products necessary to support approval of a generic drug. Typically, generic applicants need between 1,5000 and 5,000 units of the branded product to conduct studies seeking to demonstrate the necessary bioequivalence of its proposed generic product to the branded product.
The problem arises when certain branded pharmaceutical companies misuse voluntarily limited distribution programs (i.e., carried out by a purposefully selected small group of distribution pharmacies) and distribution limitations related to a Risk Evaluation and Mitigation Strategy (REMS) program (i.e., by barring certified pharmacies from making sales for developmental purposes) in order to block generic applicant access to the branded products. The FDA stated that "[t]he 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."
According to the FDA:
FDA has received numerous inquiries from prospective generic applicants indicating that they would like to develop a generic version of a marketed drug, but are unable to obtain the necessary samples of the reference listed drug (RLD) – typically referred to as the brand drug – because the RLD is subject to limited distribution. The products we have received inquiries about include both drugs that are under REMS and those that are not.
To help address this issue and to provide transparency regarding these inquiries, FDA is posting a list identifying all drug products for which FDA has received an RLD access inquiry related to limited distribution of the marketed RLD, with details regarding, among other things, the RLD sponsor, the drug product, and the number of inquiries we have received. 1 We also are disclosing when we have communicated directly to the RLD sponsor at the generic company's request. We note that such a communication is voluntary and is only an option for certain products (as further outlined below). As also described below, FDA regularly refers the RLD access inquiries we receive to the Federal Trade Commission (FTC).
The list will be updated semi-annually.
For those cases where a drug product's REM truly prohibits sale of that product to generic companies for testing due to safety concerns, the FDA has developed a review and notification process to inform the branded company in writing that it will not consider sale of the product for such testing to be a violation of the REMS. They also provided a draft Safety Determination Letter.
Whether the public listing of pharmaceutical companies will have its intended effect remains to be seen. From a public relations perspective, one would expect pharmaceutical companies to, at minimum, work to avoid appearing at the top of this FDA list, and at best, to avoid appearing on it altogether. Only time will tell.
Footnotes
1 We note that FDA has not independently investigated or confirmed the access limitations described in the inquiries received.
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