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12:00 AM
 | 
Mar 07, 2005
 |  BioCentury  |  Politics, Policy & Law

Cooler heads on safety

Judging from what happened at two Senate hearings last week - and more importantly what didn't happen - it seems that the congressional and media frenzy over drug safety has abated. Importantly, the suspension of sales of Tysabri natalizumab from Biogen Idec Inc. and partner Elan Corp. plc after two patients were diagnosed with progressive multifocal leukoencephalopathy didn't bring on a new attack on the industry.

Indeed, it now appears that legislation giving FDA some additional authority will be enacted, but rather than attempting to "fix" FDA by decoupling safety and efficacy oversight, it will likely seek to augment the agency's ability to conduct post-market safety evaluations and may give it more power to compel sponsors to conduct post-market trials.

While legislation is likely to be introduced this year, unless another high profile drug withdrawal blasts the issue onto the front pages, Congress may wait to act until it reauthorizes the Prescription Drug User Fee Act (PDUFA), which expires in 2007.

Two factors have combined to bring the drug safety issue back to earth: a deftly handled, transparent advisory committee meeting on COX-2 inhibitors last month (see BioCentury, Feb. 21), and the decision by Michael Enzi (R-Wyo.), chair of the Health, Education, Labor and Pensions (HELP) Committee, to vigorously assert his panel's jurisdiction over FDA issues.

Enzi's predecessor, Judd Gregg (R-N.H.), adopted a hands-off approach, leaving a vacuum that Sen. Chuck Grassley (R-Iowa) sought to fill through his position as Finance Committee chair. Starting last fall, Grassley blazed a trail through the media...

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