Don't be the first to take a new drug… According to former agency insiders and private-sector government watchdogs, the FDA's supposedly consumer-focused review and decision-making process is heavily influenced by the drug industry. Surprised? I'm not. Much of the controversy stems from a 1993 law-the Prescription Drug User Fee Act (PDUFA)-that allows the FDA to charge pharmaceuticals manufacturers a substantial fee for reviewing and evaluating marketable drugs. This isn't a nuisance fee-in 2001, the fees amounted to $161,713,000, just slightly less than half of the budget for FDA's review process. What's wrong with that, you ask? Well, for starters, it's a blatant conflict of interest-the FDA is supposed to be a totally objective body concerned only with public safety. How objective can they be if drug companies are footing the bills? But what's more important is this: Under PDUFA, the FDA is bound to certain timelines with regard to the review and approval process-or they can't collect the fee. This shifts the agency's primary focus toward expediency, rather than safety. And it's definitely succeeded in speeding things up. Since 1990, they've cut the time required for drug approval in half. I maintain that the drug companies' rush to get drugs to market and the FDA's eagerness to collect the fees are behind the large number of recent withdrawals from the marketplace of drugs soon after their approval. And as shocking as it is to consider, this may also be the reason why some people have died, prompting those withdrawals. But none of this should surprise you. As with any kind of corruption, you need only follow the money to discover it… Actions to take: Don't be the first to try a new drug. Ask your doctor to prescribe something that's been around for a while-it'll probably work just as well and be a lot safer too. And it would be a good idea if THE DOCTOR has been around awhile. New doctors, like new drugs, are unproven.
Raising a glass to health,
William Campbell Douglass II, MD
| 
