Speed up approval for new health care products and minimize the major drug shortage. Sounds good so far, right? Let’s hope lawmakers get this right with a new bill designed to speed delivery and avert shortages of life-saving medicines.
Throughout FDA’s history, the speed of drug, device, and biologics product approval time has swung pendulum-like first faster, then slower. Then faster and, lately, slower. Get the trend?
Let’s get some perspective on this with a brief review of recent history. First the product approval time is sped up and then three years later the first new products are approved for our health care market. Then two years after approval, our large and diverse market starts having adverse reactions or even death to these approved products. The story drastically changes roughly 6 to 7 years after Congress calls on the FDA to “speed” up the process. This time Congress calls on the FDA to “slow” down and take more review time.
As a former FDA inspector, I can speak to some of the behind the scenes problems for FDA in complying with a congressional mandate to speed up. The FDA will now have to ramp up training for new and old inspectors to conduct many more clinical trial inspectors, plus additional reviewers. In fiscal year 2006 there were a total of 248 CSOs conducting bioresearch monitoring (BIMO) investigations (Principal Investigators, IRB, Bioequivalence, Contract Research Organizations / sponsors, and Good Laboratory Practice). Just 84 of the 248 investigators (34%) only conducted one inspection. And 21 of 248 (8%) conducted nine or more BIMO inspections (this all from the FDA website). The number of inspectors in 2012 is about the same number as in 2006 (248) give or take fifty inspectors. There are hundreds of thousands of ongoing clinical trials that need review and inspection. How long do you think it will take FDA to ramp up training qualified inspectors for this job?
Congress should think about tackling these separate issues in separate bills in order to appropriate the funding for each of them. More than 80% of the funding congress gives FDA is earmarked for food work. If congress allowed FDA to focus more on drugs, biologics, and drug review, drastic extra funding may not be necessary.
In order to speed up new health product approval you need more BIMO inspections (Center directed work). In order to mitigate more drug and device shortages the FDA needs more certified Good Manufacturing Practice (GMP) and Quality Systems Inspection Technique (QSIT) auditors (District directed work). These two groups of investigators go through years of training.
The drug and device approval process is not like a supertanker ship that can easily be sped up and it takes more effort than flipping a switch. The drug shortage problem will be solved by less regulation of private industry, not a “new law” adding burden to manufacturers. I look forward to reviewing the final bill or law that comes out of this brave new plan. The FDA has been granted the user fee application process in order to fund necessary operations. This vital money received will hopefully be used to train new BIMO, GMP, and QSIT inspectors. These inspectors will in turn help speed up the new health product approval process. These complex problems demand complex answers measured in years not weeks.