Two months into her tenure at the Food & Drug Administration, and ahead of new legislation that could boost the agency’s budget by 14 percent, Margaret Hamburg is looking to give the FDA more teeth in policing medical device, drug and food makers.
“The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible. … The agency must show industry and consumers that we are on the job,” Hamburg said. “Companies must have a realistic expectation that if they are crossing the line, they will be caught. … If they fail to act, we will.”
That means no more internal haggling or lengthy negotiations with violators, an end to multiple warning letters before acting on a violation and, in cases posing a “significant” threat to public health, even action before a formal warning is sent.
The agency will no longer seek its chief counsel office’s approval before sending out warning letters, a policy instituted under former President George W. Bush. FDA will, however, begin a new practice regarding its missives: Publicly issuing a so-called “close out” letter once a violator has cleared up the problem.
The days of the agency being “hampered by unreasonable delays” are at an end, Hamburg said.
“In some cases, serious violations have gone unaddressed for far too long,” she said. “These include violations involving product quality, adulteration, and mis-branding; false, misleading, or otherwise unlawful labeling; and misleading advertising.
“Frankly, I can see in some past responses, there’s a lot of back and forth, a lot of stall and delay, [the attitude of], ‘Let’s wait and see what the company does,'” Hamburg said. “We need to be as clear as we possibly can about our expectations and standards and when there are ongoing problems or when a problem emerges that has as serious impact on health, then we have to aggressively act.
“I hope that in the future, effective FDA enforcement will not be surprising or out of the ordinary,” Hamburg said. “Ultimately, the FDA’s success 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. Enforcement of the law is not simply an end in itself — enforcement is critical to the agency’s public health mission.”
Hamburg, confirmed as commissioner in May, could have a lot more resources at her disposal to pursue the new policies. The U.S. House of Representatives last month approved a 14 percent budget boost for the agency; the legislation is working its way through the Senate.
The bill would boost the overall budget to $3 billion and send a 24 percent boost to the Center for Devices and Radiological Health, the arm that oversees the medical device industry. The CDRH budget for fiscal year 2010 would be nearly $350 million under the provisions of the bill.