Tuesday, February 15, 2005
Closing the Barn Door Board, Department of the Cattle's Out of the Barn
Budget cuts FDA safety checks
The Food and Drug Administration's proposed budget for next year includes cuts to nearly all its inspection programs, from checks on imported food to reviews of overseas plants that make prescription drugs bound for the USA.
If Congress approves, the number of domestic food safety inspections made next year would fall by 5%, foreign drug plant inspections would drop 5.8% and checks on the nation's blood banks would be cut 4.7%, compared with estimated 2005 inspections.
The reductions are included in a $1.9 billion budget that gives the agency an overall 4.5% increase. Increases are earmarked for several projects, including expansion of a network of labs to analyze food for bioterror agents and increasing staffing in the office that monitors the safety of prescription drugs once they hit the market.
But, wait, there's this:
US to strengthen drug regulation
The US regulator is to beef up its procedures for overseeing the safety of drugs already in the marketplace.
The Food and Drug Administration announced on Tuesday it will create an independent drug safety oversight board. ...
The board will include representatives from the FDA and medical experts from other agencies like the Veterans Administration.
It is expected to take steps to make the FDA's decision-making process on drugs more open and make sure drugs on the market are as safe as possible.
These will include a new drug safety web page with emerging information on side effects, and safety risks.
One-page information sheets for health care professionals and another for patients also will be made widely available.
Announcing the change, Mike Leavitt, the US House and Human Services Secretary, promised a new "culture of openness."
The FDA already has an Office of Drug Safety but consumer groups and some lawmakers have said it lacks sufficient independence and resources.
It's really hard to do a better job with less money. It's probably impossibly to accomplish by simply creating a new board, with powers and duties comparable to an existing board. Forgive me if I'm not overjoyed by the idea of one page information sheets stuffed in the little white bag from Walgreens. What's the sheet going to say? "Warning: this drug has not been carefully tested. It probably is safe to take, but you just never know. With the recent scandals involving the failure to inspect drug manufacturers and giving approval to deadly drugs like Vioxx, you might think we're doing more frequent, more thorough inspections or more thoroughly vetting drugs before releasing them to the market. We're not. Instead, we're telling you weren't not. But wait -- there's more. We promise to do a better job of unclosing the barn door once the cattle are out. In the event that we approve a deadly drug, we'll try to do a better job of minimizing the body count. Unless doing so might be adverse to the financial interests of our consultants. You understand.