Take it Away One hand gives while the other hand takes away. Unfortunately, there's more taking than giving in a new FDA rule that protects drug companies from consumers. Yes, you read that correctly. The FDA has stooped to an all time new low in pandering to giant drug companies. Last January, the FDA prepared a big beautiful sweetheart of a gift for the drug industry. But it was wrapped up to look like a gift for consumers. Very clever. The gift was a new rule that just went into effect on June 30. And Part One of the rule is actually a good idea. Have you ever read one of those information flyers that come with prescription drugs? Of course not. No one has. You've probably used a magnifying glass to check for side effects. But read the whole thing? Never. Maybe a chemist is interested in reading about the chemistry of a drug, but not when the font size is 0.1. The new FDA rule promises to change all that. Flyers for new drugs will be better-organized, easier to read, and will feature a "highlights" section to summarize benefits and risks. The key word here is "summarize." According to several media reports, drug company reps expressed concerns that if risks were only summarized their companies would be open to liability claims. The obvious solution: don't summarize the risks - spell them out at length. Information is power, right? So give consumers what they need: a full accounting of adverse side effects to watch out for. Instead, the FDA worded the rule in such a way that exempts drug companies from state product liability laws. Most of us have to wait for a very special occasion to get an extravagant gift like that. "Typical," is how Senator Ted Kennedy described the FDA rule in a Boston Globe article last January. According to the senator, what should have been a useful tool for doctors and patients instead becomes, "a protection against liability for the drug industry." In the same article, Chris Mather - spokesperson for the Association of Trial Lawyers of America - said the rule would have a "tremendous impact on people's ability to hold these companies accountable." And a January statement issued by the National Conference of State Legislatures put it a bit more bluntly: "FDA has usurped the authority of Congress, state legislatures and state courts." FDA officials are usually not so blatant about their obedience to the drug industry. But this public display of affection is enough to make one blush. Just how disgraceful is this appalling rule? Here are two exhibits offered into evidence. Exhibit One: More than two million adverse reactions to pharmaceutical drugs are recorded in U.S. hospitals each year, according to an article titled "Death by Medicine" on the Life Extension Foundation web site. And more than 780,000 deaths are associated with drug use yearly. To put that in perspective, consider cancer's death toll: In 2001, less than 555,000 people died of cancer in the U.S. Exhibit Tw In November 2004, The Wall Street Journal reported that internal Merck & Co. e-mails revealed that some Merck executives were well aware of the serious heart attack dangers associated with Vioxx. But instead of sending out warnings to doctors and Vioxx users, they wondered how they could design a study that would make the risks appear minimal. If Merck executives felt comfortable pressing forward with their Vioxx marketing blitz when they knew deaths would occur and they might be held liable, just imagine how drug company execs will be tempted to act knowing that the FDA has a box of "Get Out of Jail Free" cards waiting for them. Sources:
"Experts concerned New Drug Labels Limit Product Liability" Newswise, 6/28/06, newswise.com
"FDA Rule may Aid Drug Firms in Liability Suits" Diedtra Henderson, The Boston Globe, 1/19/06, boston.com
"FDA Final Rule on Prescription Drug Labeling" National Conference of State Legislatures, 1/19/06, ncsl.org
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