Is the FDA too influenced by big pharma?

The U.S. Food and Drug Administration's (FDA) historically sound reputation could be in jeopardy due to it's possibly too close relationship with the major pharmaceutical companies.

The FDA is the largest pharmaceutical regulator in the world and has in the past been considered tough but very fair.

The organization has always promoted strict scientific standards for drugs testing.

Now legislators and politicians have become concerned following the increased number of drug recalls and the rate of health scares involving prescription drugs, and have started inquiries into the conduct of the regulator.

That review process has rendered even more complex and drawn out because, during the inquiries, the FDA has remained leaderless.

The chink in the FDA's credibility also coincides with problems being faced by many of the big drug companies.

Many are suffering from a dearth of new products in their pipelines, with the result that they are resorting to even heavier marketing of the successful blockbusters drugs.

This media attention has seen a detrimental effect on public health, as for example, many individuals who took the now-withdrawn painkiller Vioxx did not actually need them.

The FDA has issued 58 severe safety warnings on medicines in the first nine months of this year, compared to only 26 such warnings in the same period last year and 33 black-box notices in the whole of 2004.

Most medicines carry warnings about side effects but the FDA uses a bold black border on some drugs in order to highlight side effects that it considers to be particularly serious.

Since Vioxx was withdrawn from the market in September last year amid claims that the FDA had ignored several studies reporting that the pain reliever could cause heart problems, the number of black-box warnings has increased.

During the Vioxx scandal some critics said that it demonstrated that the FDA had a greater interest in easing the regulatory burden on drug companies than in protecting public health and safety.

The agency then promised to increase its vigilance and improve its response to questions about drug safety in an attempt to dispel mounting public concern regarding the side effects of commonly prescribed drugs.

Doctors and the public have also been unhappy about the rising cost of prescription drugs.

As a rule the big drug companies are presented in the media as the bad guys, but canny lawyers, particularly in the US, have watched closely all these developments and seen that wealthy drug companies are a great target.

When Merck decided to take Vioxx off the market had the public not lost confidence in the FDA, Merck would probably not be facing 6,500 lawsuits today.

Many believe the pharmaceutical sector needs to regain the public's trust by becoming, much more proactive in its risk communication and needs to involve more trusted neutral third parties, and by being transparent about its methods of working.

It might also enhance its' reputation by providing drugs free of charge to developing countries, limiting direct-to-consumer advertising and lowering prices for certain essential products.

The industry and its' regulators also need to conduct drugs trials as early as possible and establish better and more frequent and accurate communication with the public.

It would of course also help if the media also presented more accurate and less prejudiced coverage of the big drug companies and focused on the benefits of drugs and not just the headline grabbing risks.