Pregnant women are almost always excluded from clinical trials and pregnancy is usually considered an adverse event leading to dropping women from ongoing clinical trials. FDA, along with European regulators, would like to change that. But it is not easy to implement. There is no law that could mandate inclusion of pregnant women in clinical … Read more
Once FDA has approved a product, it almost never reverses that decision unless there are compelling safety reasons such as previously unknown life-threatening events related to the drug. FDA vigorously defends its decisions and never expresses “buyer’s remorse”. A recent case emphasized this policy when FDA rejected a petition filed by a professor at Ohio … Read more
Medical practice is regulated by the State medical boards not by FDA and FDA does not get to tell doctors what they can or can not prescribe to their patients, even if it is off label. A recent court ruling, although about a narrow case, confirms this principle once again. The case in hand was … Read more
Despite the media circus around FDA’s approval of Biogen’s Aduhelm, FDA’s decision is legal and permanent. And it will be repeated for other drugs in similar situations. The controversy around this decision is being fueled by misperceptions or misunderstanding of the FDA review process. The regulatory processes and FDA interactions that preceded the FDA decision … Read more
Patient Reported Outcomes (PROs) that capture patient experience data tend to play a central role in FDA decisions about an application when used as primary endpoints in pivotal clinical trials, says a report on FDA’s Patient Focused Drug Development (PFDD) program and its impact on regulatory decisions published last week. PROs are particularly important for … Read more
Suggestions have been made in the media about the impropriety of the process followed by FDA during the review and approval of Biogen’s Aduhelm. While the process followed may not be outrightly illegal, was it ethical, and was it corrupt? It is important to review the facts before we make judgements. The Chief of FDA’s … Read more
A few years back, Theranos became a harsh example of a Founder/CEO scamming gullible investors with false and misleading science, only to be publicly discredited and gutting of the company. This week we found another company, Athira Pharma, that may have raised almost $300 million based on fraudulent research by its Founder and CEO. Aside … Read more
Slow and steady does not win the race, at least for the medical product development, as shown by two companies that were slowest of the pack of frontrunners developing Covid vaccines. In both cases, late comers face extreme hurdles to get their products to patients. This week CureVac announced poor clinical trial results with its … Read more
Many times, we read stories in the mass media about experimental breakthroughs that seems to solve major scientific questions, creating hype around the inventions and companies announcing them. Often hidden from the headlines is the fact these discoveries were made in small animal models and are years, if not decades, from being clinically relevant. This … Read more
Although FDA is not bound to accept the recommendations of its Advisory Committees (Ad Coms), it mostly does. But it is the times when FDA went against the Ad Com, that raises the question, do these committee serve the purpose they were intended? Some of FDA’s most controversial, high-impact decisions in recent times have been … Read more
