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Improvement Needed in Drug Post-Marketing Studies

WEDNESDAY, July 10 (HealthDay News) -- Since the requirement in 2007 that drug makers conduct post-marketing studies, the number of studies not yet started has declined while the number of studies fulfilling obligations has nearly doubled, according to a report published in the July 10 issue of the Journal of the American Medical Association. However, more than 40 percent of studies had not yet been started in 2011, and the number of studies with delays doubled as of 2011.

Noting that the 2007 Food and Drug Administration Amendments Act (FDAAA) requires drug makers to conduct post-marketing safety studies, Kevin Fain, J.D., M.P.H., from Johns Hopkins University in Baltimore, and colleagues extracted data from the Federal Register on the status of all post-marketing studies for both biological license and new drug applications and reviewed the status of all studies reported by the FDA from 2007 to 2011.

The researchers found that the number of post-marketing studies ranged from 1,774 to 2,227 since 2007. The total number of studies required under the FDAAA increased from zero in 2007 to 387 in 2011. The number of studies not yet started fell from 1,044 (56.7 percent) in 2007 to 775 (43.5 percent) in 2011, while the number of studies required under the FDAAA but not yet started increased to 271 (15.2 percent) in 2011. The number of completed studies that fulfilled the post-marketing obligation increased from 122 (6.6 percent) in 2007 to 224 (12.6 percent) in 2011, with no fulfilled FDAAA studies. The number of delayed studies increased from 125 (6.8 percent) in 2007 to 241 (13.5 percent) in 2011, with 19 (1.1 percent) delayed FDAAA studies by 2011.

"For those newer studies required under the FDAAA, which are steadily increasing each year, the FDA must enforce the law against companies failing to comply with study requirements," Fain and colleagues write. "These regulatory actions can help ensure the timely conduct and submission of adequate studies, which will ultimately strengthen the FDA's ongoing monitoring of prescription drug safety."

One author disclosed a financial relationship with IMS Health.

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