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Patrick Stone

Health Care

FDA Deserves Better Treatment

Senate bill could speed drug delivery, but…

Published: Friday, June 8, 2012 - 15:24

Speed up approval for new health care products and minimize a 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 the Food and Drug Administration’s (FDA) 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 the health care market. Then two years after approval, our large and diverse market starts having adverse reactions or even death to these approved products. So roughly six to seven years after Congress calls on the FDA to “speed” up the process, the story drastically changes. This time Congress calls on the FDA to “slow” down and take more review time.

As a former FDA inspector, I can speak about some of the behind-the-scenes problems for the FDA in complying with a congressional mandate to speed up. The FDA will now have to ramp up training for new and old inspectors plus additional reviewers to conduct many more clinical trial inspections.

In fiscal year 2006, there were a total of 248 consumer safety officers conducting bioresearch monitoring investigations (which involved principal investigators, institutional review boards, bioequivalence, contract research organizations and sponsors, and good laboratory practice). There were 84 investigators of the 248 (34%) who conducted just one inspection. And 21 of 248 (8%) conducted nine or more bioresearch monitoring inspections (this is all from the FDA website). The number of inspectors in 2012 is about the same as in 2006 (248), give or take 50 inspectors. There are hundreds of thousands of ongoing clinical trials that need review and inspection. How long do you think it will take the 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 percent of the funding Congress gives to the FDA is earmarked for food work. If Congress allowed the FDA to focus more on drugs, biologics, and drug review, drastic extra funding may not be necessary.

To speed up new health product approval you need more bioresearch monitoring inspections (center-directed work). To mitigate more drug and device shortages, the FDA needs more certified good manufacturing practices (GMP) and quality systems inspection techniques (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 to fund necessary operations. This vital money received will hopefully be used to train new bioresearch monitoring, 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.


About The Author

Patrick Stone’s picture

Patrick Stone

Patrick Stone works toward a future where disease cures and prevention are the main goal of all new test articles. Stone is president and lead consultant at TradeStone QA LLC, which serves the global public by protecting the supply and quality of healthcare products before entering the market place. Stone specializes in Institutional Review Board (IRB) compliance and quality assurance audits; computer system validation and 21 CFR Part 11 compliance; LIMS/data management system compliance; and 21 CFR, GCP, cGMP, and ICH compliance. Stone is the author of Bubble Gum Badge—An FDA His-Story (Xlibris Corp., 2011). You can follow Stone on Twitter.