The FDA has more than 18,000 full time employees and an annual budget of over $6 billion. It is high organized, and its regulators are considered some of the smartest in the World. It can handle challenges, or so it would appear to the lay person. Last year, FDA delayed many of its review activities … Read more
A review published in the British Medical Journal this week reported that almost 44% of drugs approved by the FDA under the accelerated approval pathway over the last 28 years have not yet been confirmed to be clinically effective, and despite that most of these unconfirmed drugs are on the US market for 5 years … Read more
Yesterday’s approval of the first interchangeable biosimilar by the FDA provides a proof of concept for biosimilars that will be treated like generic drugs in that they can be substituted for the reference product at the pharmacy without needing a specific prescription. This is a major milestone that has been almost 10 years in the … Read more
With 343 million doses administered and 163 million people fully vaccinated in the US, it may be annoying for the layman as to why has FDA not yet fully approved any vaccine. And it would not be an unreasonable question to ask, although probably unfair to the FDA. It is important to understand a few … Read more
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
