In a stunning and unexpected 6-3 ruling the right-leaning Supreme Court went against the wishes of the last president, took the wind out of the sails of health care reform of the current president, sent irresponsible Big Pharma a major wake up call, and bluntly told the arrogant FDA that they are indeed not above the rule of law. It is a major victory for every American citizen.

Is the FDA doing it's job?

Central to the issue is a power struggle between the federal government and states, which in this situation meant the federal government authority to pre-empt your state rights to sue if you are injured by a drug. The FDA, acting on behalf of the Bush administration and on the side of Big Pharma, has helped tie up thousands of drug injury lawsuits across the country. The FDA, who is supposed to be protecting consumers from drug injury and ensuring a correct risk/safety picture for any person taking a drug, was instead trying to shirk their responsibility and simply claim that Americans had no right to sue.

The Bush Administration had intentionally appointed anti-safety people in high positions within the FDA, starting with its Chief Counsel, Daniel Troy (and continued as a legal philosophy after Troy was forced out for his Big Pharma connections). Troy set in motion the legal problem the Supreme Court just decided.

During the final years of the Bush administration cancer industry insider Andrew von Eschenbach, MD, was appointed to run the FDA, and Wall Street insider, Scott Gottlieb, MD, was second in command. These individuals sought to fully implement the FDA label as senior to any rights of citizens. Their intention was to make sure that new biotech drugs would be protected from lawsuits, as the FDA wanted to speed new and even more dangerous drugs onto the market so as to foster the development of the biotech industry. In essence, the FDA management wanted to turn the American public into one large clinical experiment, with no right of recourse when injured.

This was occurring against a backdrop wherein the FDA couldn’t even name all the drugs currently on the market, had failed to demand required aftermarket follow up safety testing on drugs, and had intentionally withheld safety information on existing drugs from the public. The current situation with drugs is that almost no drug, even blockbusters and those in use for decades, have an accurate risk/benefit profile.

FDA allows tidal wave of drugs.

The FDA knows that when a new drug is approved for the market the full extent and range of  side effects won’t be known for years. History shows us time and again that Big Pharma actively hides risk data from the FDA and pays for “science” that distorts reality. This irresponsible behavior goes along with closed-door negotiations with the FDA, and has resulted in numerous drug disasters like Vioxx. FDA managers oftentimes go against the wishes of their own safety scientists and then move on to six figure salaries in the industry they regulate. Doctors are not apprised of the actual risks and consumers are left in the dark.

The FDA insistence that a drug label (based on what is known at the time of approval) should supersede citizen’s states rights to sue if they were injured has almost nothing to do with consumer safety. Rather, it is a federal power grab that is in the best financial interests of Big Pharma and Big Biotech, industries that do not have consumer safety as their top priority.

Experts believe this system is so badly broken, due to gross FDA mismanagement, that it will take 10 years of studies and many billions of dollars just to understand the actual risks of the drugs Americans are already taking.

In writing for the majority, Justice John Paul Stevens put Big Pharma on notice. The defendant in this case, Wyeth, had argued that it could not comply with both federal and state law. Stevens told them they had a fundamental misunderstanding of regulation and were trying to hide behind the FDA, going on to say that it is a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.

That is not what Big Pharma wanted to hear.