Author Archives: StevenGrossman

FDA Guidance on Biosimilars: The Two Minute Version

If you are in the business of developing biosimilar products—or thinking about it—then you have to read all three guidance documents published by FDA on February 9, 2012. They provide essential (but not complete) instructions for how to construct and implement a biosimilar development plan. Continue reading

FDA and Industry Relations: A Mix of Frustration and Respect

There is no one answer to the question: what is the state of FDA-industry relations? FDA Mattershears some say: FDA does what industry asks it to do, the agency is a puppet. Others say that FDA is obstinately blocking industries’ path to new, better and innovative products. Yet others say FDA is misguided at points, but well-intentioned and most often right. Continue reading

Will Increased User Fees Result in a Faster, Safer Approval Process?

How long should it take to review a medical device for public use? The FDA’s current average, 73 days, is too much time, according to the medical device industry.  Patient advocacy groups however, claim the current process is rushed and at times negligent. A safer, faster approval process would certainly benefit everyone, but enhancements cost money. That’s where user fees come in. Continue reading

User Fee Reauthorization: FDA Is In Trouble If 2007 Repeats Itself

Starting this week, the House will hold hearings on reauthorizing the drug and medical device user fee programs that fund one-fourth of the agency. While user fees have become largely non-controversial, this “must-pass” legislation is Congress’ opportunity to consider dozens of other FDA issues, some controversial and many time-consuming. Continue reading

The State of the FDA—January 2012

FDA is the only federal agency that touches the lives of every American several times every day. It’s remarkably broad mandate includes all medical products and 80% of the nation’s food supply, plus countless other products. Despite this, when the President delivers his State of the Union (SOTU) address to Congress this week, it is unlikely that FDA will rate a mention. Continue reading

Did FDA Have A Good Year in 2011? Medical Innovation, Food Safety, and Imports

Before turning to 2012, FDA Matters wanted to take one more look at FDA’s performance in 2011. So much happens at FDA that it’s easy to lose perspective. And no matter what the agency does, somebody will be unhappy. So, should Commissioner Hamburg feel good about the last 12 months? Continue reading

Post-Market Safety: Can Sentinel Do Some of the Heavy Lifting?

In the FDA-regulated world, success is often defined as approval of a new product or indication based on two, well-controlled clinical trials. However, the scrutiny doesn’t end there. FDA’s mission includes determining whether already-approved drugs perform safely and effectively when used by large numbers of patients in routine medical practice. Continue reading

Beyond Plan B: Scientific Integrity and a Possible 3rd Class of Drugs

Patient access to the emergency hormonal contraceptive “Plan B One-Step” has been one of the most combustible issues ever faced by FDA. It received more attention last week when FDA approved expanded access for adolescents under 17 and HHS Secretary Katherine Sebelius promptly overruled the agency because she found inadequate scientific support for the decision. (For my readers outside the US, here is a New York Times article that provides background). Continue reading

Animal Research is an NIH issue, not the FDA. Or is it?

The value of animal research in the life sciences is considered an NIH issue. FDA Matters believes that FDA and its stakeholders should be equally involved.

Animal research is the vital first step in the development of new medical products. Before any safety or efficacy testing is permitted in humans, FDA must be satisfied with animal testing data submitted by the product sponsor. Pick any medical breakthrough and you will find animals were tested prior to humans. Continue reading