Edward John Allera, chairman of Buchanan Ingersoll & Rooney's FDA/Biotechnology Section and managing shareholder of the firm's Washington, D.C., office, served as a special guest on the June 3, 2010, edition of BioBusiness.TV — an independent Internet TV network for life sciences investors and executives. Allera was featured in the FDA special video series titled "Biotech In the Money" and was asked to weigh in on the following topics:
- Why the paradigm shift at the FDA over the past five years?
- Is anything binding with the FDA anymore, or are companies just not listening?
- Chronic disease vs. critical needs: the FDA fast track and recourses for companies.
- Biosimilars are without a champion at the FDA.
- FDA very actively enforcing compliance regulation
- If you had unlimited powers, how would you reform the FDA?
- Combination therapy in the eyes of the FDA. Can we let FDA off the hook? The system return to a more rational process.
In regards to question one, Allera discussed the tremendous change at the FDA in the past five years as it underwent a complete philosophical change. He explained that contributing factors include the Medicare Monetization Act (MMA, Medicare Part D), the change of control of Congress to the Democrats, the Food & Drug Amendments Act, the new (Obama) Administration and its Healthcare Reform. He argued that the perception of government was that "the pendulum had [swung] too far to the approval side." Now, in the post-Vioxx-era, with Congressional oversight on the FDA, there is a much greater risk aversion, he said.
In response to question number two, Allera explained how the FDA gives nuanced answers, and too often, companies hear what they want to hear. He argued that companies should learn to listen, and since FDA is "holding all the cards" it is healthy to get as many people as possible (Congress, key opinion leaders, media) looking at the trial to add more transparency and accountability to the FDA reviewal process. He also commented on the recent Dendreon Provenge approval.
The interview for the video series was conducted at the NASDAQ Marketsite on May 26, 2010, in New York City.