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This article was originally published in RAJ Devices

Executive Summary

Former FDA commissioner, Lester Crawford, joins lobbying firm

Former FDA commissioner, Lester Crawford, joins lobbying firm

Lester Crawford, who resigned as commissioner of the US Food and Drug Administration (FDA) in September 2005, has joined Policy Direction Inc (PDI), a lobbying group based in Washington, DC1. Mr Crawford joins as senior counsel.

PDI, which was founded in 1995, describes itself as specialising in customised advocacy in areas including biotechnology, human drug, and medical device regulation; healthcare; and biomedical research. The company claims to have influenced many important decisions made by the FDA for its corporate clients. In one example, the group says that it successfully achieved FDA advisory committee support for a product that had originally been voted down2. It also lists among its client achievements lobbying Congress to put pressure on the FDA to remove illegal and unapproved medical devices from the market.

Controversial tenure

No reason was given for Mr Crawford?s sudden departure from the FDA, where he had been commissioner for a little more than two months, having earlier been acting commissioner and deputy commissioner.

Mr Crawford?s final months at the FDA were marked by controversy. He was confirmed as permanent commissioner in July 2005, but his appointment secured the backing of the Senate only after a commitment was given that the agency would decide by 1 September 2005 on whether or not the emergency contraception, Plan B, should be available over-the-counter, as an FDA advisory panel had recommended. Following his confirmation, Mr Crawford announced that the agency was delaying its decision on Plan B.

The agency was also in the headlines over whether it had notified physicians quickly enough about a faulty implantable cardiac defibrillator that led to the death of a college student earlier in 2005. There was also the withdrawal of Merck & Co?s COX-2 inhibitor, Vioxx (rofecoxib), which was followed by claims that the FDA had failed to act quickly enough after safety concerns relating to the product first surfaced.

References

1. Policy Direction Inc website, accessed 9 February 2006, www.poldir.com

2. Policy Direction Inc website, accessed 27 February 2006, www.poldir.com/client.htm

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