FDA Report Card 2015: Cooperation With Industry

Enforcement

I think FDA genuinely wants to support innovation. I've been working in this industry for about 30 years, and this is the most interested I've seen FDA in improving regulatory systems to spur innovation.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green

Before, during, and after enactment of the 1976 Amendments, a significant number of industry and professional/health associations maintained beneficial and effective relationships with the FDA. At present, the latter are not involved to the same extent and the latter are limited to fewer Industry groups and perhaps less productive influence for the benefit of members.

—Larry R. Pilot, Attorney at Law

The relationship between industry and FDA is akin to the American legal system, with a prosecution and a defense. To a certain extent, it is supposed to be an adversarial relationship—of course, both sides should be polite and respectful, but they should not be the best of friends. This is the way the system is designed to work. Whether it works that way today is the question.

—Michael Drues, PhD, president, Vascular Sciences