Pocket change On paper (well, half a sheet at least) it looks like a major coup for patients and consumers. But the new FDA drug safety bill seems to have more to do with implementing new ways the agency can collect enormous sums of money than it does with truly protecting the public from the ever-increasing dangers of patent drugs. Which could, perhaps, explain why it met with such sweeping -- and uncharacteristically bipartisan -- support while making its way through Congress: It passed through the House of Representatives with a vote of 405-7 and won a unanimous victory from the Senate. After all, who can appreciate profits over public safety more than politicians? But, I digress. The "new" powers granted to the FDA supposedly allow it to crack down on drug makers whose products show serious side effects after hitting the market. The legislation enables the FDA to require new warnings on drugs that have already been approved, to order drug companies to complete post-approval safety studies, and to limit the distribution of a drug if there is enough concern over side effects caused by it. Wait just a minute, though…Isn't the FDA's main responsibility to keep products like that off the market in the first place? And don't they already have those powers to begin with? What they don't have though, is the ability to slap drug companies with hefty fines (generally in the $10-million range) for every violation the FDA discovers. (And if the fines are that high, imagine what they might get paid to keep those violations out of the public eye?) Even if the drug companies suddenly become models of safety and efficacy, they'll still have to fork over an additional $225 million over the next five years to help the FDA "fund post-approval safety monitoring." Don't get me wrong: I'm certainly not begging sympathy for drug companies. And I agree wholeheartedly that someone should be cracking down on them for any side effects that their products cause. What I have a problem with is that no one is cracking down on the FDA itself for allowing the situation to get this bad. I also take exception to the fact that the agency doesn't appear to be all that interested in doing its job unless there's something (or hundreds of millions of somethings) in it for them. And the part of this legislation that I think I find most disturbing is that, in essence, the FDA will now be making extra money for not doing its job right the first time around. So will this new drug safety bill actually make you any safer? I guess that depends on just how deep the FDA's pockets really are… Source:
"US Senate OKs FDA drug safety bill, sends to Bush," Reuters Health news, 9/21/07 | 
