Health Inc.

3 Ways To Shed More Light On FDA

The Food and Drug Administration regulates 25 cents out of every dollar in the U.S. economy, including most of our food and all of our medicines.

So what's it doing with all that power? The answer is surprisingly murky.

Making good on an early promise from the Obama administration, a government panel offered a slew of suggestions today to make FDA's activities easier to keep tabs on. And it's asking for public comment.

Here's a hit list of the three suggestions that look to us like the ones that will get the most attention and why:

1. Disclose the most common observations of unsafe or unsanitary practices found during FDA inspections and disclose when an inspection has been conducted.

FDA and its contractors conduct both routine inspections and for-cause inspections of companies' offices and factories. Companies aren't likely to be enthusiastic about a provision that could make it appear to the public that the company has a problem.

But releasing more inspection details like the ones in the recent J&J recall of liquid children's meds containing "dark flecks" might create more public pressure on these companies to clean up their act.


2. Disclose when a company files a new drug application, and to some extent, why FDA decided to reject it or the company withdraws it.

Patient and their advocates will love this, because they will be able to see what's in the pipeline, but as veteran FDA-watcher Merrill Goozner notes in his blog, "This information will also be of great interest to company rivals, Wall Street analysts, industry consultants and academic and independent observers who closely monitor R&D activities."

FDA second-in-command Dr. Joshua Sharfstein, writing in the New England Journal of Medicine today, says the group "believes that implementing some of the proposals would accelerate the development process for medical products by allowing companies to learn from the successes and failures of other products."


3. Give the public more information on recalls and when they end, as well as make it clearer when patient or doctors have reported problems with FDA-regulated products.

Perhaps this one is a no-brainer, but even FDA officials have admitted privately that their information systems leave a lot to be desired.

The drug industry trade group told Forbes it is still reviewing the proposal.

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