GAO to investigate FDA drug-review process

WASHINGTON The Government Accountability Office will investigate the Food and Drug Administration’s drug-review process, according to the Associated Press. This is a result of the recent problems linked to two FDA approved drugs, GlaxoSmithKline’s diabetes drug Avandia and Merck and Schering-Plough’s cholesterol drug Vytorin.

The FDA approved Avandia because it helped control blood sugar, which many doctors believe decreases diabetics’ risk of heart attack. But the agency came under fire last year when an analysis showed Avandia could actually increase heart attack risk. The agency argued that it has never required diabetes drugs to show lower heart attack risk, and that lowering blood sugar alone is an important benefit.

The agency approved Vytorin, which combines Schering-Plough’s Zetia with Merck’s cholesterol drug Zocor, based on its cholesterol-lowering capability. But a study released earlier this year showed Vytorin was no more effective at limiting plaque buildup in neck arteries than Zocor alone.

At issue now is whether the FDA should approve drugs based on factors like cholesterol and blood sugar, without evidence they improve more meaningful measures like survival.

Also, the FDA has been criticized for not following up on companies when they ask for follow-up studies on drugs. In a recent report, the FDA said 900 of more than 1,200 studies required of drug makers had not even begun. To help with this, the FDA is enacting a new law next month that fines companies up to a million dollars for failing to honor drug study commitments.