Pharma, FDA still lagging in post-marketing safety research

The good news: Drugmakers are wrapping up more post-marketing safety studies, now that the FDA can crack the whip. More good news: Companies got to work on a bigger proportion of the studies required.

The bad news: More than 40% of required studies still haven't begun, and the percentage of completions is still quite low.

Here's the background: Before 2007, post-marketing safety trials were voluntary. That year, the Food and Drug Administration Amendments Act gave the FDA more power to push drugmakers to do the research. Because safety issues often go unnoticed until a drug is used by a broad swatch of the population, these studies are important for monitoring potential side effects, or gauging the severity of risks identified during clinical trials. Just think of the weight-gain risks that cropped up for atypical antipsychotics like Eli Lilly's ($LLY) Zyprexa, or the heart-safety concerns about GlaxoSmithKline's ($GSK) diabetes drug Avandia.

Last year, the Institute of Medicine raised questions about the FDA's follow-up on post-marketing studies. Now, some Johns Hopkins University researchers have taken a look at the data. In a letter published by the Journal of the American Medical Association, the researchers said the proportion of completed studies rose to 12.6% in 2011, up from 6.6% in 2007.

The percentage of studies that got underway grew, too. Some 56% of required studies hadn't been initiated in 2007; by 2011, that fraction had declined to 43.5%, the researchers said. In absolute numbers, that's 775 lagging studies in 2011, compared with 1,044 in 2007.

Stating the case this way is an accentuate-the-positive approach; looking at it from the opposite direction, the percentage of studies that haven't been completed still topped 85% in 2011. And the number that hadn't begun amounted to more than half. So, the gains are real but leave a lot of room for improvement. Plus, the authors point out, the number of delayed studies rose to 241 in 2011, or 13.5%, up from 125 and 6.8% in 2007.

- read the MedPage Today story
- find the JAMA article

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