Sunday, August 23, 2009

Lawmaking and the GAO Report: A Dose of Reality

By James J. Gormley

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?
The Gormley Files - Blogged