Crocodile Tears for FDA
If you follow regulatory news and read Jill Wechsler’s column in Pharmaceutical Technology, you know that FDA’s constant refrain is “We need more money.” When the public learned of a flu-vaccine shortage, when Vioxx was recalled, and when contaminated heparin was discovered, it was always the same story. Citizens and lawmakers asked FDA why they hadn’t identified or prevented these problems, and the agency always cited budgetary constraints.
When I compared the estimated costs of FDA’s initiatives with the money Congress allocated for them, the agency’s lament seemed justified and I sympathized. I sympathize less now.
The House Committee on Energy and Commerce revealed that FDA is paying large retention bonuses to its highest-paid officials. Last year, the agency’s chief of regulatory affairs received bonuses totaling $48,663. The highest bonus paid to a field inspector was almost twenty times less.
The money lavished on high-ranking FDA employees is excessive. If any workers need an incentive to stay with the agency, they are the field inspectors. They are the ones making less money. They’re also the ones who can protect us from contaminated drugs and food.
In 2007, FDA spent $35 million on bonuses that exceeded $4000. That money could have hired field inspectors the agency always says it needs. What would happen if we appointed an ombudsman to oversee how the agency uses its budget? Would FDA find another excuse for not doing a better job?
Hi,
The fact that the FDA has been in ’soup’ for some time now is well known…what is also (hopefully) well known that the USFDA is one of the two leading drug regulation bodies that the rest of the world looks up to. But it seems that now, thanks to Lobbying by Big Pharma, the FDA is losingmore than just face- its losing faith among the people, globally! The Avandia case serves as an example in point- within 48 hours of Steve Nissen’s meta analyses being publishhed, the USFDA approved Avandia lost ~15% of market share by way of recalled/refused prescriptions (while GSK also lost a little more than just that). The fact that prescriptions were adversely affected BEFORE the FDA could even respond with a press statement indicates that the masses have already accepted the ‘whistle blower’ and ‘pharma vigilantes’ as more trustworthy than the USFDA’s people. Unless the FDA stems this tide and stalls the corruption within (not to mention reconciling its own in-fighting offices of New Drug Approvals and the Post Market Surveillance Office), the loss of face would seem rather acute and potentially irreversible. If that happened, it won’t just harm the US where recourse (and retribution) is still relatively fast and assured….but it would adveresely and irreparably affect the global population whose Drug Regulatory bodies look to the USFDA and the EMEA for ‘initial assessment of approvability’ for any new drug/agent entering their markets. Of course, there’s independent due-diligence for these new agents….but the FDA verdict (almost) always forms a key aspect of the ‘tipping point’ decision on whether ‘to permit or not to permit’ the new agent’s sales. Just a thought…thanks for the read.
Sujoy.
The “We-need-more-money” refrain from FDA has become the boilerplate response to public laments over FDA performance.
As Erik Greb reveals, the boots-on-the-ground FDA personnel who do the grunt work in keeping the US drug supply safe and effective get short shrift when it comes to retention bonuses, and other inducements to hang around the agency.
The public must become become aware of the large number of attorneys (and other non-scientific personnel) who labor for the FDA – and undoubtedly get the lions’ share of the retention bonuses for performance.
It’s not that the agency needs more money; it’s that the money be allocated to to those folks who actually do the grunt work that keeps FDA semi-functional.
Thanks for your comment, Jack. It does seem to me that those who need the most incentive to stay at FDA get the least incentive. Still, I don’t mean to belittle the contributions of lawyers, managers, and other nonscientific and nonfield employees at FDA. We need them just as much.
Also, if you compare FDA employees’ salaries to those in the pharmaceutical industry, you could argue that FDA is underfunded. The agency might well need more money after all to entice people to work for them rather than in the industry.