PharmExec Blog

FDA Readies More Warning Letters, Fast Enforcement Action

WASHINGTON - MAY 07:  Dr. Margaret Hamburg tes...
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FDA officials have been promising stiffer enforcement of manufacturing and marketing requirements for several months, and commissioner Margaret Hamburg is moving full-speed ahead to fulfill those predictions. Last month, FDA announced it will issue warning letters quickly when it finds violations and will require manufacturers to respond promptly. Too many serious violations “have gone unaddressed for far too long,” including failings with product quality, adulteration and false and misleading labeling and advertising, Hamburg commented at a meeting sponsored by the Food and Drug Law Institute. The commissioner wants to limit all the back-and-forth wrangling with regulated companies that delays compliance. And if there’s a situation that raises serious health and safety issues, FDA may launch a recall or seizure before even issuing a warning letter, she warned.

Under the new program, manufacturers will have 15 working days after receiving an inspection report to respond to any cited violations. If FDA doesn’t receive a sufficient response in that timeframe, the agency will issue a warning letter. The 15-day policy was described in an Aug.10 Federal Register notice and will apply to violation notices issued after Sept. 15.

On its part, FDA will try to promptly reinspect or investigate a company’s efforts to correct violations. If the problems are not corrected, though, the agency won’t just issue another warning letter, but will look at penalties, seizure, closures or other action.

Carrot for Compliance
In addition to waving a bigger stick, FDA wants to encourage pharma companies to quickly address violations by establishing a formal process for resolving enforcement actions. After determining that problems cited in a warning letter have been corrected, beginning this month the agency will state that compliance in a formal close-out letter and post the information on its website. This gives companies an official statement to show investors and customers that they’re back in FDA’s good graces, and that a facility or product is no longer tainted.

Another important change is to end the extra legal review of warning letters before they are sent out. The Bush administration revised procedures so that the FDA chief counsel examined all warning letters, a policy that was criticized for delaying and reducing agency enforcement actions against industry. “This created very cumbersome practices without a lot of benefit,” Hamburg commented. Now each FDA center will review and identify those warning letters should go to the chief counsel because they raise “novel, complex and sensitive issues,” such as an activity involved in a lawsuit or recently established by legislation.

Hamburg hopes that these policies will spur speedy corrective efforts by cited companies and encourage broader compliance throughout industry. Publicizing agency enforcement actions, she said, will increase public confidence in the agency and better educate patients and consumer about potential risks in medical products.

Faster review of violations and follow-up to corrective actions will require more resources, which Hamburg says are now available due to FDA budget increases. The food safety legislation before Congress also will give the agency some additional enforcement tools.

Hamburg expects an initial increase in warning letters but hopes that the volume will level off over the long run as industry recognizes that a strong compliance program is good for business and for consumers. FDA’s success in spurring compliance “should be measured not by the number of warning letters or injunctions or seizures,” she said, but by “our impact on the health and welfare of the public.” Failure to meet FDA standards means that a company is “putting the public at risk” and also “jeopardizing the public’s confidence in your industry.”

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