FDA Requests Feedback on Older Approved Generic Drugs

The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics.

Dubbed PANDAs (Pre-Hatch-Waxman ANDAs) by the agency, the drugs were first approved even earlier, between 1938 and 1962, when the agency only required drugs to be proven safe rather than both safe and effective.

After a 1962 law — the Kefauver-Harris Drug Amendments — required drugs to be proven effective as well as safe, the agency set up a process called “Drug Efficacy Study Implementation” to prove that the previously approved drugs were effective so that sponsors of new generics could rely on them as reference drugs.

But the agency now says that “there may be some confusion about the applicability of certain statutory and regulatory provisions to PANDAs” and it wants to hear from holders of “PANDAs and other interested persons regarding whether there are regulatory or policy rationales” for treating PANDAs differently from other ANDA applications.