WASHINGTON - Sounding a call for a more communicative culture at the FDA, its acting commissioner, Lester Crawford, addressed a lunchtime crowd gathered at the BIO-Windhover 2005 conference here.
"It's a new world for the FDA," he said, "because we live in a culture that calls for a different communication modality."
The public, Crawford added, is looking to the FDA as a reliable source of information. Safety, of course, is the chief issue that has raised consciousness about the FDA's role, and Crawford acknowledged that "there's been a lot of public scrutiny over this issue."
That topic has gained attention during the past year, largely due to product recalls of the once-popular COX-2 painkiller drugs. More recently, the agency approved Biogen Idec Inc.'s Tysabri, only to see the company withdraw the drug months later due to the discovery of deaths linked to progressive multifocal leukoencephalopathy. As a result, drug safety was a central theme during a senate committee hearing on Crawford's nomination to lead the FDA on a permanent basis. (See BioWorld Today, March 19, 2005.)
At that hearing, and again at the conference, he defended the FDA.
"It is important that these concerns do not distort the fact that drugs are safer today than they ever have been before," Crawford said, "and that millions of Americans each day benefit from them."
Efforts to improve the agency's product surveillance include the newly established Drug Safety Oversight Board, as well as its soon-to-be-unveiled DrugWatch web page to better provide the public with emerging data and risk figures.
"We've heard from the public," he added, "and it's clear to me and it's clear to [Health and Human Services Secretary Mike Leavitt] that this is what the American people expect from the FDA."
Crawford stressed that perceived shifts in the agency's risk-management paradigm would not compromise product approvals. But while the FDA plans to improve its public image, Crawford's reputation has been called into question.
A long-time FDA official in a variety of high-ranking posts, Crawford received President Bush's nomination two months ago to permanently take the reins. He has served as the agency's temporary commissioner since Mark McClellan left more than a year ago to serve as administrator of the Centers for Medicare & Medicaid Services, but Crawford's official nomination ran into a roadblock. Allegations of a personal relationship with an unnamed female official at the FDA, made by an anonymous agency employee, have delayed a senate committee vote on his appointment, pending investigation of the charges. (See BioWorld Today, Feb. 23, 2004; Feb. 16, 2005; and April 18, 2005.)
That topic was not touched on in his remarks, though he did comment on important industry issues.
Crawford told the crowd to watch for a delayed policy guidance on follow-on biologics, as well as related guidance papers on immunogenicity and chemistry. He also called the agency's Critical Path Initiative - its plan for better using proven biomarkers, new trial designs and simulation modeling in the product development continuum - a key step in increasing success in proportion with capital growth in research and development. To that end, the FDA soon will publish its National Critical Path Opportunities List.
"We hope this list will be a catalyst for many stakeholders," Crawford said, "to get involved and begin to modernize the tools we use to develop better products."
Crawford then fielded questions on the Critical Path Initiative, as well as the merits and demerits of direct-to-consumer advertising, and closed his remarks.
The three-day event was the fourth BIO-Windhover event and served as a partnering meeting.