4. How should FDA share suggestions for improving ANDA
submissions with industry, beyond issuing regulatory
My question is this: Is the poor quality of ANDA submissions a result of confusion on the filing company’s part, or
is it an unwillingness to do the work to gain the necessary
scientific understanding? The most recent U.S Supreme Court
decisions making “pay for delay” illegal4 raise the stakes for not
being first to file.
In 2013, the FDA shocked us by withdrawing Welbutrin,
an approved generic that had met scientific requirements for
comparability, after years of complaints from patients that
it did not behave in the same way as the brand product. The
million-dollar fine levied to Ranbaxy for serious GMP issues
that include clinical fraud has cast a dark cloud over the safety
and efficacy of generic drugs.
This overture to industry by FDA is motivated partially by
a legal commitment from GDUFA and, I believe, by a genu-
ine desire to improve not only the ANDA submission process
but to ensure the safety and efficacy of the drugs manufac-
tured. It remains to be seen if the generic drug industry can
live up to their commitments and save the public money but
also bring high-quality, low-cost drugs to the general public:
the true goal of the Hatch-Waxman Act. 5
1. Code of Federal Register [Docket No. FDA-2014-N-0032]
2. Generic Pharmaceutical Association http://www.gphaonline.
3. Public Law 112-144, Title III
4. Federal Trade Commission vs. Actavis http://www.supremecourt.
5. Hatch-Waxman Act – http://en.wikipedia.org/wiki/Drug_Price_
Bikash Chatterjee has been involved in the biopharmaceutical, pharmaceutical, medical device, and diagnostics industry
for over 30 years. His expertise includes site selection, project
management, design, and validation of facilities for U.S. and
European regulatory requirements.