Avandia case highlights need for FDA transparency


This week’s Food and Drug Administration (FDA) advisory committee’s meeting on the controversial diabetes drug Avandia, which the New York Times reports on here, helps highlight the need for more transparency at the agency–but also show its limits. According to the Times, GlaxoSmithKline hid data from the Food and Drug Administration (FDA) revealing that the drug could cause health problems.

In May, FDA published this list of 21 draft proposals to increase transparency in the drug, medical device, and other aspects of the agency. Reading through the list is an exercise in: “what, you mean they don’t already have to do that?”

For example, the  FDA would like to have the authority to ask companies to supply simple basic information about why a particular product has been recalled. (Remember salmonella in peanut butter?) This would ensure that the data it plans to release this fall (which we wrote about here) would be more complete.

The agency also proposes to give the public access to reports of “adverse events”–instances when drugs or medical devices are causing harm–in a format that is “searchable and and allows users to generate summary reports of this information.”

The agency  says it would like to notify the public when a company files a request to investigate a new drug or medical device, thereby starting clinical trials, and also to inform us when and if that application is withdrawn, placed on hold, or terminated.

And it would like to issue “relevant summary safety and effectiveness information” for a product that has not gotten approval yet,” if the Agency concludes that “disclosure is in the interest of public health.” This speaks partially to the problem at the core of our investigation, “Heart of the Matter: How Congress and Special Interests Kept Clinical Trial Data Secret,” which explored how Congress, under heavy lobbying by the drug and medical device industries, created a loophole that permits data to be withheld from the public for drugs and medical devices that don’t make it to market.

However, in leaving it to the agency to decide, behind closed doors, when “disclosure is in the interest of public health,” rather than letting all the information be free for reporters, experts, and everyone to see, this proposal is limited. As the journal Nature Medicine recently opined (subscription required):

In the end, new rules and regulations mean little if they are not implemented fully. The FDA, for instance, has yet to fully hew to its long-standing policy of releasing its analyses of drugs approved for new indications. Moreover, clinical trial sponsors are already required to register their trials with a US National Institutes of Health (NIH) database, but a recent analysis showed that only about half do so in a timely and complete way.

And, as the Times notes, current required posting of clinical trials “are often little more than cryptic references.”

In the case of Avandia, where crucial data reportedly were withheld, the agency cannot make available what it doesn’t have any more than the U.S. Federal Election Commission can provide information about campaign contributions that a candidate does not report.

Meanwhile, there’s no guarantee that the FDA will implement all its transparency proposals. Comments are due on July 20 either at regulations.gov, or at www.fda.gov/transparency. So far there are not many comments posted. Afia Asamoah, the FDA’s transparency initiative coordinator, says that often comments come flooding in the last few days before the the closing date.