WASHINGTON, DC—It is not a matter of lack of personnel or authority, but the ability to act quickly to exert existing authority that impedes the Food and Drug Administration in its enforcement efforts, according to new FDA Commissioner Dr Margaret Hamburg. Speaking at a Food and Drug Law Institute conference here last month, Dr Hamburg said that swifter enforcement of food and drug safety laws will be a high priority for FDA during her tenure.

“Again and again, from all sides of various questions, I heard support for a strong FDA,” Dr Hamburg said. “A strong FDA has credibility with the public. A strong FDA is transparent in explaining its decisions. A strong FDA pursues creative solutions to longstanding problems and is always looking for novel ways to prevent illness and promote health. And a strong FDA enforces the law.”

“Effective enforcement has many clear benefits to public health,” she added. “It enables FDA to intercept unsafe or fraudulent products promptly… and prevent additional harm. By holding violators accountable, enforcement deters others who would put the public at risk or prey upon vulnerable consumers. Visible and clearly explained enforcement actions inform members of the public about potential dangers. And enforcement helps industry too – by maintaining a level playing field for safe products. Making sure that offenders are held legally accountable prevents companies from having to choose between doing the right thing and staying competitive.”

According to Dr Hamburg, FDA must be swift and vigilant in keeping to its schedule of regular inspections and in following up on signals that something might be wrong with a product. The agency must also be highly visible in its efforts, showing consumers and industry that it is doing its job. “In recent years, the Government Accountability Office and others have suggested that the FDA’s enforcement efforts may not have always lived up to these principles,” Dr Hamburg admitted.

By stepping up its enforcement activities and shoring up safety in a clear, visible way, Dr Hamburg hopes to turn around a trend in public perception of the agency that is distinctly negative. “Ultimately, an effective enforcement strategy creates public confidence in FDA oversight, which in turn keeps trust in the safety of FDA-regulated products from eroding,” Dr Hamburg explained. “Such confidence is critical to the long-term interest of both consumers and industry.”

Steps to Better Enforcement

In recent years, FDA’s enforcement efforts have been on a down slope. In FY 2000, FDA issued 1,154 warning letters to industry. By FY 2005, that number had dropped to 535. A report issued by FDA in March puts the number of FY 2008 warning letters at 445. “Reports have noted that there has been a steep decline in the FDA’s enforcement activity over the past several years,” Dr Hamburg noted. “At the same time, many of the enforcement actions that the FDA has undertaken have been hampered by unreasonable delays.”

According to Dr Hamburg, the enforcement decline is less a matter of lack of resources than unneeded bureaucracy. “The pathways for enforcement action can be too long and arduous when the public’s health is in jeopardy. We are fixing these pathways to improve the effectiveness of our enforcement system.”

Doctor Hamburg outlined six steps that the agency will take in order to improve its enforcement efforts. The first is that FDA will set post-inspection deadlines. When FDA provides an inspection report identifying serious findings, a manufacturer will generally have no more than 15 days to respond before FDA moves ahead with a warning letter or enforcement action. Also FDA will take steps to speed up the issuing of those warning letters. Dr Hamburg has suggested to FDA counsel that the agency limit review of warning letters to significant legal issues to help streamline the process.

FDA will also work with other industry regulators to develop better risk control and enforcement strategies. “In many food safety cases, for example, local, state, and international officials have more authority to take action quickly than the FDA,” Dr Hamburg explained. “When the public health is at risk, the FDA will reach out to our partners to take rapid action while we alert the public and prepare longer-term responses.”

The agency will also no longer issue multiple warning letters to a manufacturer before undertaking enforcement action, Dr Hamburg said. And if FDA finds that there is an imminent health risk, it will consider immediate enforcement action prior to any warning letter being issued.

At her direction, FDA will also begin developing a formal warning letter “close-out” process, Dr Hamburg explained. If the agency can determine that a firm has fully corrected the violations raised in a warning letter, FDA will provide a letter indicating that the issues have been successfully addressed. The agency will also indicate on the FDA web site that the firm has received such a close-out letter. “For ongoing violations, it could play an important motivating role to spur corrective action,” Dr Hamburg declared. “I hope that receiving a ‘close-out’ letter quickly becomes a top industry priority.”

Recent Enforcement Successes

Dr Hamburg cited two recent incidents as examples of swift and sure FDA enforcement. “Soon after the identification of the H1N1 influenza virus, several web sties began promoting products that fraudulently claimed to diagnose, prevent, or treat the disease,” she said. “These products included everything from a shampoo that claimed to protect against H1N1 to a costly electronic device that claimed to use ‘deeply penetrating mega-frequency life-force energy waves.’ Many of the products made claims that sounded more plausible, but were still fraudulent.”

There was no question, noted Dr Hamburg, that the web sties could easily confuse consumers and prevent them from seeking appropriate and necessary treatment. On May 1, the agency issued a general warning letter to consumers and sites making such claims, and as of last month, FDA had issued 65 warning letters to offending web sites, covering 125 products. Approximately 80% of those sites have complied with FDA’s requests, and by mid-June, the rate at which new web sites were appearing had slowed to about two per week.

“[At the beginning of August], we took action against companies selling anabolic steroids under the guise of dietary supplements,” Dr Hamburg said. One such company, American Cellular Labs, sold eight such products on its website, making such claims as “[With ESTRO Xtreme] you get two estrogen blocking effects in one fantastic product!”

“In fact, these over-the-counter body-building products have been associated with serious and life-threatening adverse events, including liver injury, stroke, kidney failure, and pulmonary embolism,” Dr Hamburg declared. “These are unproven and unapproved drugs, not dietary supplements.”

In addition to sending warning letters, FDA posted a public health advisory and other materials urging consumers to stop taking bodybuilding supplements from any manufacturer that are labeled as containing androgen-, estrogen-, and progestin-related active ingredients. “By pairing enforcement action with education, we hope to prevent others from being harmed by these products,” Dr Hamburg asserted.

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