FDA chief warns industry, part of drive to restore agency’s image after Bush-era product woes

FDA chief’s pledge signals tougher safety stance

WASHINGTON — A pledge Thursday by the Food and Drug Administration’s new chief to crack down on companies that break the law reflects her effort to restore the agency’s image after high-profile safety problems during the Bush administration.

FDA Commissioner Margaret Hamburg told an audience of food and drug company lawyers they should expect to see faster, tougher action against companies that don’t follow FDA regulations.

“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.”

For years, the agency has been criticized by Congress for its handling of safety problems involving products ranging from blood thinners to salmonella-tainted peppers to peanut butter that required one of the largest food recalls in U.S. history.

Hamburg’s speech marked a significant departure from past addresses by Bush administration-era FDA officials, who usually stressed their collaborative efforts with drug makers to bring new treatments to market.

“They have a deep hole to get out of in order to re-establish the agency’s credibility, and this seems like a good start,” said Ira Loss, an analyst with Washington Analysis, a research group.

Since Hamburg’s confirmation in May, the FDA has undertaken a series of rapid-fire enforcement actions against companies selling bogus or dangerous products.

In May, the agency ordered dozens of Web sites to stop marketing more than 100 phony swine flu remedies. A month later, regulators warned consumers to stop using the popular nasal decongestant Zicam Cold because it can permanently damage the sense of smell.

Last week, the agency wrote to manufacturers of dietary supplements that contain metabolic steroids, warning them to pull their products from the market.

In her speech Thursday, Hamburg suggested this aggressive stance will become routine.

“I hope that in the future, effective FDA enforcement will not be surprising or out of the ordinary,” she told attendees of the Food and Drug Law Institute conference.

The FDA has struggled over the years to keep up with its rising responsibilities to oversee health care and food products, which account for one-fourth of the U.S. economy. President Barack Obama tapped Hamburg, a former New York City health commissioner, to try to restore the agency’s credibility.

Hamburg said the agency’s efforts in recent years “have been hampered by unreasonable delays.”

“In some cases, serious violations have gone unaddressed for far too long,” she added.

FDA’s primary enforcement tools are warning letters, sent to companies that violate rules for manufacturing and marketing products. Over the past 10 years, the number of such letters has plummeted.

Last year, for instance, the agency issued 22 letters to drug companies for improper advertisements, down from 157 letters in 1998. A Government Accountability Office report found that in the time it takes the FDA to send a warning letter after a problem has been detected — an average of four months — the advertisement at issue is often no longer even in use.

Hamburg on Thursday announced several changes designed to speed the pace of warning letters. They include a streamlined review process for sending the letters and shorter deadlines for companies to respond.

Loss said a stronger FDA would bolster public confidence in the safety of company products.

“This is in the best interests of every industry regulated by the FDA,” Loss said. “It improves everybody’s credibility.”

Consumer advocates generally say they’re encouraged by the agency’s new leadership. But some say the FDA should seek expanded powers to protect consumers. Dr. Sidney Wolfe, of the consumer advocacy group Public Citizen, noted that unlike with drugs, the agency still lacks authority to review the safety of dietary supplements before they are launched.

“There has not been an FDA commissioner — not under Clinton or Bush or before — saying we need more statutory authority over dietary supplements,” said Wolfe, who is acting president of the group.

But many observers say the FDA has already been saddled with too many responsibilities by Congress, often without the money to carry them out. In 2007, the agency’s independent group of science advisers said the FDA was at risk of failing in its mission due to a lack of expertise and resources.

The Obama administration’s fiscal year 2010 budget proposal would increase FDA’s federal funding by more than 14 percent, to $2.35 billion from $2.06 billion. The spending bill passed the House earlier this month and is moving through the Senate.