Is the FDA above the law?
The FDA is mandated with protecting us. But the FDA has, by its own actions— and sometimes inaction—become the willing accomplices of those very forces they're supposed to protect us from.
Congress has stepped forward to try to right the ship, but it's no easy feat. One of the most serious scandals to emerge from the FDA's reckless behavior revolved around the antibiotic Ketek. a drug sold as an antibiotic. People were dying, and the drug's maker and the FDA behaved as if this were acceptable collateral damage.
It wasn't acceptable, and they knew it—before the dangers surfaced. And Congress wants to know exactly when they knew it.
Unfortunately, that has become a familiar theme in the world of pharmaceuticals: what did you know, and when did you know it?
And if you think the drug companies or the FDA are forthcoming in their answers, then hold onto your hat.
The FDA has actually refused a direct request from Congress to hand over their records regarding Ketek. Mind you, the FDA is a government agency. But forget for the people, by the people, because the FDA has taken the stance that it's above the people—and the law, and not willing to part with the relevant documents.
I guess it's a little embarrassing—not to mention incriminating—to share records that show they had knowledge of doctored trials that were done by a weight-loss clinic, no less. (I know—I can't figure out what a weight-loss clinic has to do with an antibiotic, either, but when you're trying to buy a soul, you sometimes have to look in strange places.)
The head of the FDA—a former Pharma employee—testified before a Congressional committee and was, in polite terms, less than truthful. In legal terms, it's called perjury, and it doesn't look like he'll be able to escape unscathed from that one.
One scientist with a conscience has served as the principle whistle-blower— saving more lives in the long run than we'll ever know. By his account, the inside of the FDA resembles something out of the old Soviet Communist party line: tow the party line, or else.
Call or write to your Congressman and let him (or her) know that enough is enough. Make the FDA accountable, or come election time, they may be the next ones ousted.
