FDA Policy Change for Letters Warning of Violations Raises Concerns
A recent policy change at the FDA has "substantially cut back" the number of warning letters the agency sends to companies in violation of federal rules, prompting concern among some lawmakers that the agency is "backing away from its obligation to protect the public with aggressive enforcement," the Wall Street Journal reports. In February, the FDA adopted a policy that requires the FDA chief counsel's office to approve all warning letters to ensure they are "legally sound." Previously, FDA division and district offices sent the letters independently. According to an FDA record review, 279 warning letters have been sent since the policy change, a 64% drop in the number of letters sent compared to the same period last year. According to the FDA, the counsel's office has rejected only 6% of the 699 warning letters it received. But the Journal reports that division and district offices "may be holding back letters they once would have sent." Over the last decade, the FDA has averaged about 1,000 warning letters a year for a variety of reasons, such as ad infractions, food-processing violations and "sloppy drug-making." FDA officials said they adopted the new policy after the food and drug industries complained that the warning letters -- the agency's main method to ensure compliance - "lacked consistency ... [and] depending on the enforcement district, some companies would get cited and others wouldn't."
Concerned that the new policy "lets violators off the hook," Rep. Henry Waxman (D-Calif.) plans to send a letter today to HHS Secretary Tommy Thompson calling the policy change "[part of a] pattern of FDA actions that benefit regulated industries but jeopardize public health." Rep. John Dingell (D-Mich.), a member of the House Energy and Commerce Committee, which oversees the FDA, said, "The growing evidence of substantial malfeasance in many companies regulated by FDA makes (this) decision highly questionable, and I intend to have it examined closely." Sen. Edward Kennedy (D-Mass.) said he intends to raise the issue with FDA Commissioner nominee Mark McClellan during his confirmation hearing (Adams, Wall Street Journal, 10/1).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.