FDA Takes Baby Step in the Right Direction

At least they are taking the first step and admitting they are “powerless” againt the cost of regulation. The FDA now plans speed drug tests and trim costs for small companies and university researchers. From the Boston Globe:

The Food and Drug Administration yesterday issued new guidelines that make it easier for scientists working in universities and small companies to test promising therapies in humans without matching the hefty spending of large drug companies.

The FDA’s new standards create an earlier stage of clinical trials that allow researchers to test very small doses of experimental drugs in fewer patients, paring expenses and, drug manufacturers hope, providing a quicker way to flag potential failures.

Right now, the FDA says 9 of 10 experimental drugs fail in clinical testing that can cost companies millions. And many experimental drugs go untested in humans because the current system requires massive investments before the make-or-break stage of drug development.

”This will allow us to test a broader variety of compounds in people early and then pick the best one for taking forward,” said Dr. Janet Woodcock, the FDA’s deputy commissioner for operations.

Unfortunately, the FDA is not going nearly far enough, and have already cost the lives of countless Americans with their current system. Former Upjohn research scientist Mary Ruwart (I’ve got a copy of her original study) provides:

The death toll from losing half of our innovations from 1962 to 2003 is somewhere between 4 and 16 million people depending upon the assumptions used. Adding the 4.7 million deaths due to an extra 10 years of development time suggests that as many as one out of three people who died of disease since 1962 may have done so needlessly.

The 1962 Kefauver-Harris Amendments may very well be the deadliest law that Congress ever passed.

Instead of keeping me safe from my medicine, I’d much prefer the FDA to keep my medicine safe from government.

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