Crawford seeks to restore confidence in FDA approval process

After months of delay, the Senate confirmed Lester M. Crawford, DVM, PhD, in July as the official head of FDA. Despite efforts by some Senators to hold up the vote pending resolution of some FDA policies, most legislators agreed with Republican and Democratic leaders that the agency would be better off with a permanent chief than without.

Having served as either FDA's acting or deputy commissioner for the last 5 years, Dr Crawford has already hit the ground running. He briefed members of Congress on reports of deaths related to mifepristone, announced changes in FDA leadership, and answered pointed questions from members of the House Appropriations subcommittee that deals with FDA's budget.

A much-watched indication of how Dr Crawford will handle hot issues will come with the agency's decision on a nonprescription version of the "morning after" pill, Plan B. FDA faces a September 1 deadline for determining the product's status, providing Dr Crawford with an opportunity to demonstrate whether FDA decisions will be based solely on scientific and medical evidence-or whether they will also be subject to political pressure.

One of Dr Crawford's greatest challenges in the coming months will be to restore public confidence in FDA's capacity to capture and assess information on drug risks and benefits during clinical trials, during the application review process, and after a drug comes to market. FDA officials are looking to a panel convened by the Institute of Medicine (IOM) to provide a roadmap for revising its system for monitoring adverse drug events without adding new layers to FDA oversight operations.

At the July meeting of the IOM panel, officials from the Center for Drug Evaluation and Research (CDER) emphasized the importance of interaction between staffers in the Office of New Drugs (OND) and the Office of Drug Safety (ODS), partly to counter proposals from Congress to move the ODS operation out of CDER. But they also acknowledged that additional resources could provide access to valuable information on drug utilization and safety from real-world resources.

One fear of the R&D community is that FDA will avoid approving higher-risk drugs by requiring manufacturers to conduct longer and larger clinical studies. Moves to expand pre-approval studies in order to detect less common side effects earlier could prompt drug companies to cancel drug development programs altogether and delay patient access to potentially valuable treatments, explained OND director John Jenkins, MD.

A challenge for Dr Crawford will be to maintain a focus on medical research and new product development while taking steps to limit adverse events and expand disclosure of safety concerns.

MULTIPLE CHALLENGES

Dr Crawford will be addressing a number of other issues likely to affect patient access to prescription drugs, including:

Critics contend that voluntary DTC ad limits won't solve the problem, but Dr Crawford is expected to wait a year to see if the industry policy addresses concerns from health-care consumers.