FDA “Mea Culpa” Part of a Cautionary Tale | Page 3
Published Online: September 25, 2013
Tracey L. Regan
Fleming described the controversy’s legacy as mixed. The controversy over Avandia, he said, led directly to diabetes drugs having to undergo cardiovascular safety trials. “This is not necessarily a bad idea, but it’s expensive and adds 3 to 4 more years to the drug review. However, the question remains: Should this be a slavish requirement? If no other drug in the class has shown a problem, it’s probably not a good idea, not just from the standpoint of cost but in terms of consuming patients who are a scarce resource. Drug companies can afford to do the trial, but they are tapping out a resource that is under pressure. The negative effect of that may be that important trials are suffering from competition for this resource from trials that are not important and take a substantial amount of time to process.”
By contrast, he noted, anti-obesity drugs have not been required to do cardiovascular safety trials. “They are done on a case-by-case basis for cause. With type 2 diabetes drugs, we are headed in that direction, but it’s unclear how quickly.” “Going forward, I think we need to look to a stepwise process, which should be formalized by the agency, in which products make it out of review sooner but under more restrictive use. We shouldn’t have a one-size-fits-all approach or set the bar so high that it impedes development of important therapies.”
1. FDA panel votes narrowly to modify Avandia restrictions, June 6, 2013. http://www.reuters.com/ article/2013/06/06/avandia-fda-idUSL1N0EH1XH20130606. Accessed September 10, 2013.
2. FDA website. FDA significantly restricts access to the diabetes drug Avandia. Press release, September 23, 2010. http://www.fda.gov/ NewsEvents/Newsroom/PressAnnouncements/ ucm226975.htm Accessed September 10, 2013.
3. FDA website. FDA Drug Safety Communication: Updated Risk Evaluation and Mitigation Strategy (REMS) to Restrict Access to Rosiglitazone-containing Medicines including Avandia, Avandamet, and Avandaryl. Press release, May 18, 2011. http:// www.fda.gov/Drugs/DrugSafety/ucm255005. htm. Accessed September 10, 2013.
4. CDC website. Percentage of US adults with diagnosed diabetes, by State 2010. http://www. cdc.gov/diabetes/atlas/countydata/atlas.html, Accessed June 20, 2013.
5. Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes [published online May 21, 2007]. N Eng J Med. 2007;356(24):2457-2471.