New sheriff in town at the FDA: Hamburg, new deputies round up risky products

7/20/2009

NEW YORK —Earlier this month, Food and Drug Administration commissioner Margaret Hamburg put the finishing touches on the agency’s new organization chart—and gone from that chart are any FDA senior officials who had worked for the agency during the previous Bush administration. That means there’s not only a new sheriff in town, there’s a whole new line of deputies as well. And judging from the actions so far this year—voluntary recalls of 14 Hydroxycut products and two Zicam SKUs, black-boxed warnings for Chantix and Zyban prescription smoking-cessation products, and a public meeting around the safety of acetaminophen with action expected to come later this year—these new regulators are looking to hit the ground running.

Executives throughout the industry are mixed as to how this may impact the business of over-the-counter medicines, pharmaceuticals and dietary supplements. All agree that the FDA just in the past few months has become much more aggressive in pursuing a safety-first agenda borne out of what were deemed agency failures during the last administration—including the late-in-coming Vioxx recall, contaminated heparin and the extensive peanut recall.

“In recent years, the agency has struggled to handle controversies involving the safety of regulated products, opening the door to legitimate questions from the media, the public and Congress about whether the public interest is being served,” Hamburg and deputy commissioner Joshua Sharfstein wrote in the New England Journal of Medicine last month. So one of the goals for the new FDA is to reclaim that faith in the agency. “One of the greatest challenges facing any public health agency is that of risk communication,” Hamburg wrote. “When it comes to food and drugs, even small risks can cause considerable fear and anxiety.… To be credible in all these tasks, the agency must communicate frequently and clearly about risks and benefits.”

Some feel that the fallout from questions of medicinal or supplement safety will be a stronger industry with proven products. This is especially true with the supplement industry, which suffers from an ill-deserved reputation that it is unregulated. Others are concerned the safety pendulum may be swinging too far, where products and the companies that produce them are besmirched by even the slightest hint of a safety concern without any chance of defending a product’s safety record before action is publicly taken.

That has many companies concerned about an FDA that acts quickly and publicly before a company has a chance to defend its product’s safety profile, more so than any concern over a more aggressive agency.

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