Keeping the Process Honest

Peggy Hamburg is also interested in tackling the sensitive issue of conflicts of interest, and whether eliminating such conflicts is always in the best interest of science. Informed evaluation of new drugs requires input from experts outside the agency, and Hamburg acknowledges the importance of populating FDA advisory boards with people who have the appropriate knowledge.

The problem is that many top experts have relationships with companies developing products. Hamburg notes that a range of stakeholders have advised her not to exclude necessary experts from discussions.

Commitment to Enforcement

In addition to promoting science and safety, Hamburg wants to enhance FDA's clout in enforcing compliance with its rules. In a high-profile address last August, the Commissioner outlined a more aggressive, more efficient FDA compliance program, and issued the agency's expectations that manufacturers of drugs and medical products will take an equally serious stance in this area. Setting clear enforcement policy, she said, will increase public confidence in FDA oversight, while establishing a level playing field for industry and keeping unsafe and fraudulent products off the market.

Too many serious violations "have gone unaddressed for far too long," Hamburg says, citing problems with product quality, false and unlawful labeling, and misleading advertising. She explained that she wants to limit the back-and-forth between FDA and regulated companies, and encourage fast resolution of enforcement actions.

The "carrot" for manufacturers is a "close-out letter" for companies to inform investors and customers when a facility or product is no longer tainted. The stick for frequent and serious violations is product recalls or seizures, even before issuing a warning letter in situations that raise serious health and safety issues.

FDA's success in spurring compliance "should be measured not by the number of warning letters or injunctions or seizures, [but by] our impact on the health and welfare of the public," says Hamburg. Failure to meet FDA standards not only puts the public at risk, she notes, it is also "jeopardizing the public's confidence in industry."

The message is that FDA is determined to share responsibility for public health problems with industry, as evidenced by the proliferation of post approval safety studies the agency is now requiring as a condition for market authorization.