One hundreds years and some solitude at the FDA

The FDA might need a shoulder replacement for patting itself on the back. They celebrated "A Century of Protecting and Promoting Public Health" with a ceremony at the Harvey W. Wiley federal building. Or I assume they did. I wasn't there, but they had a press release by way of a personal invitation. Losts of dignitaries, including Secretary of Health and Human Services, Michael Leavitt. Purpose?

The FDA's centennial celebration, which include conferences and special forums in cities from coast to coast, have the following aims:

• Observe FDA's role -- past, present and future -- domestically and internationally in protecting and promoting the health of the public;
• Inspire future efforts to advance science, innovation, and public health through partnerships and alliances with key FDA stakeholders;
• Attract new generations of regulatory scientists; and
• Salute the contributions of FDA employees, alumni, legislators, academicians, industry, consumer groups, and public health leaders to fulfilling FDA's mission. (FDA Press Release)

I'm not sure if Representative Henry Waxman (D. - CA) was invited to make a presentation, but if he did make he could certainly speak to the first aim: Observe FDA's role -- past, present and future -- domestically and internationally in protecting and promoting the health of the public. His committee has been making these observations:

In 2005, FDA headquarters issued 535 warning letters to companies, a 54% decline from 1,154 such notices issued in 2000, according to a report by the House Government Reform Committee's Democratic staff.

But over the same period, the number of violations reported by FDA inspectors in the field barely budged, dipping just 1% -- from 6,334 to 6,268. (LA Times)

FDA countered it was carefully husbanding scarce resources by targeting the most important problems. Indeed there were some high profile cases against some big drug companies (GSK, Schering-Plough, Baxter Healthcare). But overall enforcement of the industry is down.

The report found fewer warning letters issued by each of the FDA's five centers, which together are responsible for a range of products, including drugs, medical devices and foods. Warning letters are an intermediate enforcement measure, less dire than criminal prosecution, civil fines or product seizures. The letters require written response from the company; failure to correct violations can have serious consequences.

"I think there is a public health problem here," said Dr. Michael Wilkes, vice dean for medical education at the UC Davis medical school.

Wilkes reviewed several dozen cases collected by Waxman's investigators in which inspectors had recommended action but headquarters disagreed or did not act promptly.

The report identified 138 cases in which headquarters did not take enforcement actions recommended by inspectors. Many involved medium-sized or small companies selling over-the-counter remedies, not pharmaceutical giants. "I can't explain why the FDA is taking a position where they are being passive," Wilkes said.

One of the cases Wilkes reviewed involved an over-the-counter asthma medication containing an ingredient that could prompt dangerous side effects, particularly in children. Another involved a hangover remedy that contained toxic levels of caffeine and had sent three people to the emergency room. In both cases, FDA headquarters did not send warning letters within specified timeframes.

In another case, the agency ultimately did not take enforcement action against an Ohio medical gas supplier after a nitrogen tank mislabeled as oxygen was connected to a nursing home's oxygen-delivery system. Four patients died as a result. (LA Times)

Maybe FDA is just having a bad year (or six).