[ OUR OPINION ]
FDA needs more staff
and funds, not more
bureaucracy
|
Coupled with the flu vaccine shortage that has the elderly, chronically ill and young children competing for the medicine, the FDA's reputation has taken a beating and has medical experts and an influential Republican senator, Charles Grassley of Iowa, calling for a separate agency to monitor drug safety.
Adding another office to an already tangled bureaucracy likely will meet tough resistance from the drug industry, its congressional and administration allies and the FDA itself.
It might be far more constructive and less politically challenging for Washington to revamp the FDA so that drug safety inspections are done autonomously and to provide the agency with sufficient funds and staff to do its job properly.
Moreover, Congress should extend its oversight rather than reacting to crises after the fact, particularly since the agency has had a number of difficulties of late. Grievances about the way the FDA does business -- from drug companies, consumers and even from those inside the agency -- indicate something is awry.
During a Senate committee hearing earlier this month, David Graham, a 20-year FDA veteran, testified that the agency's regulators were "virtually incapable of protecting America" from unsafe drugs. Graham's harsh assessment followed Merck & Co.'s withdrawal of the painkiller Vioxx, the largest-ever pull of a prescription drug from the market. More than 20 million Americans had used Vioxx, which has been linked to heart attacks and strokes.
Graham, who led the study of Vioxx's cardiovascular risks, faulted the FDA for not warning the public sooner about the dangers and identified five other prescription drugs he contends pose serious safety risks that aren't being addressed. FDA officials responded defensively, criticizing Graham as irresponsible, but later tightened restrictions on one those medicines.
As troubling as the FDA's stance are its managers' attempts to discredit Graham. According to accounts in the Washington Post and the British Medical Journal, anonymous FDA officials called the Government Accountability Project, a group that protects whistle-blowers from whom Graham -- fearing for his job -- sought help. The callers claimed Graham had "bullied" fellow employees, among other charges. But the group was able to identify that the phone numbers were assigned to FDA managers and discounted the accusations as implausible.
Such smears and intimidating tactics should not go unexamined. Sen. Grassley has asked for an investigation and the Bush administration should uncover the misconduct and remove those who participated.
The shortage of flu vaccine can be traced to the FDA's inattention to warnings about supply disruptions after an American company's production plant in Britain was found to be contaminated last year and again in August. Although the company told the FDA of the problem, it also assured the agency it could deliver clean vaccines. Instead of seeking alternative suppliers, the FDA simply crossed its fingers and hoped for the best.
The FDA has been remiss in its other mission -- to secure food safety. For almost two months last year, it had been aware of hepatitis A contamination of green onions imported from Mexico, but failed to warn the public. More than 1,000 people were sickened and three died.
Congress should act to strengthen the FDA, but before hatching new branches, it should bolster the existing ones.
