Two recent articles in the New England Journal of Medicine dealt with problems at the U.S. Food and Drug Administration (FDA), particularly the lack of public confidence in the agency and the need for reform (1,2). The FDA oversees 25% of the U.S. consumer economy, from food to cosmetics, drugs and medical devices. (2)

"Public opinion polls show that confidence in the FDA fell from 80% in the 1970s to 36% in 2006 - ratings usually reserved for tobacco companies and used-car dealers." (2).

The authors specifically mention the Vioxx scandal, the heparin contamination, and a recent decision by the U.S. Supreme Court concerning medical devices:

"[The Supreme Court] ruled in February that FDA approval of a medical device precluded lawsuits brought by patients against the manufacturer over adverse events in state courts. ... [This leaves] patients without recourse if the FDA has certified that a medical device is generally safe and effective. In effect, FDA approval is now a shield protecting a manufacturer from subsequent claims - a role the agency undoubtedly never intended to play. A similar case, involving drugs, will be argued before the Court this fall." (2)

Problems with adulterated drugs, like the heparin affair, are blamed on the fact that today 80% of all active pharmaceutical ingredients (APIs), i.e. starting materials for drugs, are imported from factories with questionable safety standards, primarily in China and India. The heparin contamination, for example, was traced to a Chinese supplier. The FDA monitors foreign manufacturers of APIs, but doesn't have the resources to do a thorough job.

The authors go on to point out that it is the FDA's mandate to inspect producers of both drugs and chemicals used to manufacture drugs, in order to certify that plants meet the current Good Manufacturing Practice (GMP) standards. This includes the inspection of factories abroad. One author then goes on to say that:

"... It is inappropriate and unrealistic to expect the FDA to ensure the integrity of every manufacturer's entire supply chain. If a manufacturer chooses to save money by purchasing raw material from China, then it must bear the additional costs of zealous quality control and oversight in a country with a very limited regulatory system and a fluid commercial structure. ... U.S. taxpayers shouldn't have to pay to send inspectors to every factory in China to allow industry to obtain cheaper and largely unregulated products there." (2).

The authors rightly point out that the adulteration of drugs cannot be prevented solely by regulatory agencies. It has to be the responsibility of the manufacturer, with the FDA providing the regulatory framework. To rectify the situation, the authors call for holding manufacturers responsible for the safety of their products, and for increased funding for the FDA:

"The public's health is at stake, and the time for adequate funding of the FDA is now." (2).

It may well be that the FDA is underfunded, but the key to food and drug safety is surely to hold manufacturers responsible for what they sell. Given Merck's behaviour in the Vioxx affair, it is unlikely that Big Pharma will act responsibly without the threat of lawsuits. The recent decision by the U.S. Supreme Court concerning medical devices has obviously lessened even that threat, although a case involving drugs has yet to be decided. Even the threat of lawsuits doesn't seem much of a deterrent though. Settlements of class action suits in the billions still leave the richest pharmaceutical companies with net profits from selling products that harm. The financial, if unethical, bottom line is that lawsuits are just part of doing business.

This leaves regulatory oversight, which brings us back to Americans' low opinion of the FDA. This low opinion has little to do with the agency's lack of funding, and throwing money at the problem isn't going to restore public confidence. The problem is simply the public's perception that the agency is controlled and corrupted by the very industry it is supposed to oversee.

Sources

1. Schweitzer SO. Trying times at the FDA - The challenge of ensuring the safety of imported pharmaceuticals. N Engl J Med 2008;358:1773-1777.
2. Wood AJJ. Playing "Kick the FDA" - Risk-free to players but hazardous to public health. N Engl J Med 2008;358:1774-1775.