Dr. Rath Health Foundation

Dr. Rath Health Foundation

Responsibility for a healthy world Dr. Rath Research Institute 100+ Studies Published In PubMed

Massive victory for the pharmaceutical industry as FDA considers relaxing rules on what can said about drugs

In a massive victory for the global pharmaceutical industry, the US Food and Drug Administration (FDA) is considering relaxing its rules on what companies can publicly say about their products.

(The Independent) -- The change in position represents a rare concession on the part of the FDA, a body that is proud of its fearsome reputation for total control. A new programme of reform, expected to be announced in coming weeks, could dramatically remove some of its most cherished powers.

To be commercially viable, almost every drug in the world has to pass through the FDA's tests. Drugs company share prices rise and fall on what its scientists decide.

But recent months have seen the FDA forced on to the back foot by the industry, which has successfully pursued its complaints through the courts. The FDA has lost out in two significant cases, and has now effectively admitted that it needs to change.

The heart of the issue is that the drugs companies want to be able to say more about their products than the FDA currently allows. As matters stand, the companies can tell doctors and the general public only what the FDA allows them, and only what can be backed up with conclusive scientific proof.

Some companies have products that can be used to treat more than one condition, but are banned from mentioning that dual use. Others believe they have the right to quote individual doctors' findings. Particularly sensitive is the area of dietary supplements and vitamins, where makers want the right to quote preliminary or inconclusive research. In all those cases, drugs companies believe a change in FDA policy could add hundreds of millions of dollars to annual industry sales.

The drugs companies' approach has been through the US First Amendment, a part of the constitution guaranteeing the right to free speech. Finding itself backed into a corner, the FDA has responded by organising a huge overhaul of the way it controls the companies' claims.

Within the FDA there are strong voices of dissent. Dr David Kessler, who was its commissioner for most of the 1990s, called the proposals "a frontal attack on the fundamental responsibilities of the agency ... I have great concerns that this is simply an attempt to deregulate while doing it in the name of the First Amendment."