The FDA and Pharmaceutical Companies: Who’s Protecting Consumers?

The Food and Drug Administration (FDA) is supposed to protect American families before pharmaceutical products go on the shelves. Lately, the FDA is getting a lot of press and a lot of heat for failing to keep faulty products off the market.

Take Heparin for instance.

In November 2007, actor Dennis Quaid’s newborn twins were given a near-fatal dose of the blood-thinner, Heparin. Instead of the 10 units the twins should have received, they were given a dose 1,000 times stronger. Why? Because adult dose Heparin and infant doses are stored in very similar vials. The mistake is not uncommon – six newborns in Indianapolis were also given overdoses. Three died.

According to an AP article, 7,000 Americans die each year from medication errors.

Now living in the nightmare of drug-related mistakes, Quaid said, “his family's brush with tragedy underscores the need to hold pharmaceutical companies accountable through lawsuits, a remedy that is becoming increasingly problematic for injured consumers.”

Pharmaceutical companies are now arguing before Congress for protection from their own mistakes. They are proposing that federal regulation should preempt the filing of failure-to-warn lawsuits under state law. Lawyers will soon be testifying regarding the same issue before the Supreme Court this year in a case from Vermont (Levine v. Wyeth (Lawyers USA No. 9934602) Vermont Supreme Court No. 2004-384. Oct. 27, 2006).

In the last few months, the FDA has come under fire again regarding Heparin. Like every other American company rushing to China to save money on cheap labor and manufacturing, pharmaceutical companies have jumped on the bandwagon. And, like toys and dog food, consumers ultimately pay the price of these dangerous drugs. Doses of Heparin made in China were linked to 81 deaths and hundreds of allergic reactions. Before releasing the Heparin to hospitals, neither Chinese authorities nor the FDA checked the facilities making the drug. After the deaths and injuries, the FDA did not order a total recall of drug made in China, fearing that there would be a shortage. As of last week, U.S. Health and Human Service Secretary Mike Leavitt announced that processes were now in place to ensure the safety of Heparin in the United States.

The United Auto Workers of America (UAW) have put together a campaign to urge Congress to get the FDA back on track and out from under the influence of pharmaceutical companies. Here’s what they recommend:

• Tell Congress to protect the public by not allowing scientists with ANY financial ties to the pharmaceutical industry to be voting members on advisory committees that evaluate drug safety.
• Urge Congress to require better surveillance and warning labels regarding serious side effects of new drugs, and to require a waiting period before direct-to-consumer advertising can begin.
• Tell Congress to provide adequate funds to the FDA for drug safety programs, and to make sure the pharmaceutical industry does not subvert these programs.

Addresses and more information about writing your congressperson can be found here.

Check out the UAW’s other consumer action issues here.