How FDA Makes Tough Decisions
This article was originally published in RPM Report
The reapproval of Tysabri is a rare but not unprecedented event. By coincidence, litigation against FDA made public the process the agency used the last time it let a withdrawn product return to market.
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The Future of Drug Regulation: An Interview With Center for Drug Evaluation & Research Director Janet Woodcock
FDA’s top drug regulator sat down for us for an interview about the agency’s efforts to build a higher quality regulatory system in the US—one that focuses on the “content” of regulatory standards rather than just the process. The discussion touched on the need for new and improved standards in classes like weight loss and rheumatology (albeit for very different reasons); the characteristics that make for good drug reviewers (and their managers); and on the drug center’s responsibility for preserving private sector drug development.
Some Big Pharma have looked at the risk-reward equation for gastrointestinal R&D and they have opted out. But GI still represents a massive opportunity for Big Pharma, both in terms of its traditional primary care strengths and more recent forays into specialist medicine. This combination should open up new doors for GI-focused biotech players, several of which feel they can succeed where pharma has failed in tricky areas like IBS, with next generation drugs. Others have hitched their stars to commercially unvalidated targets, exploring new and potentially lucrative mechanisms of action.
The market resurrection of Tysabri demonstrates the power of risk management but raises a tough question: how far can FDA and industry go into the practice of medicine? Biogen Idec declare they are nt trying to tell doctors how to practice. The strict rules of the risk management plan suggest otherwise.