Friday, February 20, 2009

The FDA: 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 bankrupt 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 (emphasis mine): “…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 many recommendations, 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.” Aside from the fact that the number of adverse events directly attributed to dietary supplements would be trivial, in general, especially when compared to prescription and non-prescription drugs, the SAER Law already well protects consumers.

On top of this, the FDA 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.”

What I would argue is that why should America give more power and more money to an agency that is ill-equipped to handle, and undeserving of, either?

Here is a brief snapshot of an agency that is in chaos, completely mismanaged and rife with corruption:

• On September 20th, 2006, Sen. Chuck Grassley (R-IA)’s “oversight of the drug-safety agency” “exposed a “too-cozy relationship with the pharmaceutical drug industry and an agency culture that has sought to suppress concerns of agency scientists about drug safety reforms.” Grassley’s demand to the FDA pointed to violations of the public trust, including: “FDA’s suppression of scientific dissent and pressure to alter or exclude [negative] information” relating to drug approvals.

• On October 17th, 2006, the U.S. federal court (Case Number 06-438M) charged a now former FDA commissioner with conflict of interest and related offenses relating to undisclosed pharma connections.

• In November 2007, the Subcommittee on Science and Technology issued a damning report on the FDA entitled FDA Science and Mission at Risk. The report concluded, in part:
a. FDA’s evaluation methods have remained largely unchanged for the last half century.
b. FDA’s scientific workforce does not have sufficient capacity or capability.
c. The FDA has demonstrated a consistent inability to implement needed changes.
d. The recommendations of reviews of the FDA are seldom followed.

• Congressman Dingell --- a leading voice now demanding more resources for FDA --- back on November 17th, 2008, charged the agency with “mismanagement of agency resources” and launched an investigation into the “integrity of the Food and Drug Administration.”

• According to the non-profit group, the Project on Government Oversight (POGO) on February 18th, 2009, “Since 2006, the FDA is not ensuring that medical devices such as defibrillators, pacemakers, replacement heart valves and coronary stents are being tested according to good laboratory practices (GLPs).”

Fortunately, a number of far-sighted consumer organizations want to improve the FDA from its foundations, such as the American Association for Health Freedom, which is leading a campaign to reform the troubled agency.

Gormley Take-Away: Despite the grandstanding consumer-safety posturing from certain lawmakers suggesting that consumers are not protected from supplements, what we all desperately need protecting from is the FDA, itself, which, in its current state, is powerful, unresponsive, political, inept and corrupt. Should we perhaps establish an agency to shield us from the FDA? Better yet, let’s completely reform the agency from the bottom up, but let’s not give more power to an agency that already has more than it deserves to wield or give more resources to FDA until it proves it has (1) eliminated corruption and (2) knows how to better manage the resources (and authority) it already has.
The Gormley Files - Blogged