FDA INSIGHTS NEWSLETTER
A newsletter of priceless wisdom from former FDA officials
FDA Fights a Battle on
Two Critical Fronts
Carmen Medina, M.P.H,. Ph.D. (c)
Former FDA Investigator
Did you know that FDA is losing so many brilliant minds to industry that it is actually affecting the agency’s capability to effectively and expeditiously review the industry’s regulatory submissions? Not only is this “brain-drain” affecting the agency’s review activities but the loss of seasoned, well-trained personnel also affects its ability to perform much needed field inspections - both domestically and throughout foreign countries that import drugs like heparin.
When I want to hire a consultant for my company or need to identify talent for one of my clients, I begin my search within the FDA. There’s no one better since an FDA official is going to bring with them the “behind the scenes” knowledge and expertise so often needed while preparing for a new product launch or trouble-shooting compliance challenges.
But as we selfishly pursue the talents of FDA insiders and pillage the agency, the industry is left with fewer and fewer specialists to review their regulatory submissions. There is no question that FDA's best and brightest can leave for higher paying positions within industry making it harder for the agency to review applications, bring new products to market, inspect foreign importers and police US manufacturers.
With this phenomenon only continuing to increase, the growing concern impacts all of us. It is a challenge for the FDA, the industry and consumers that has given rise to interesting dialogue but not many solutions.
While Congress heaps more domestic and international responsibility on the agency, the average age of current FDA staffing is close to retirement age. FDA is seeking new hires and younger staff but continues to hit a wall with funding.
Even if FDA is successful at recruiting bright, young scientists; unfortunately, the issue is retention after investing a few good years of training and developing them to the point where they become quite desirable to the industry recruiter.
Indisputably the agency needs additional funding from Congress to perform its public health duty and infuse new blood into its veins.
The agency currently operates with less than a $3 billion dollar budget - not nearly enough to perform all of the much needed over seas inspections and keep the domestic field safe for its citizens. Recent requests for additional funding have been made by FDA Commissioner Andrew von Eschenbach, which led to the FDA's Senate subcommittee’s passing a bill to provide additional funds. Hopefully, FDA’s brain-drain challenge has not gone beyond the proverbial tipping point.
FDA Passes New Legislation
Learn more about FDA’s new regulatory requirements. Specifically, the Food and Drug Administration Amendments Act of 2007(FDAAA) U.S. Public Health Law 110-85, also known as FDAAA:
- FDAAA strengthens FDA’s authority
- Expected to significantly increase post-approval trials
- Improves safety of FDA regulated products (Clinical Trial Material-CTM)
- Creates new rules regarding television advertisements
and much more about FDAAA in our FDA Insights, August Edition.
See next article for current issue of FDA Insights:
Samaras Flow Chart for Medical Device Development |
