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Tuesday, July 17, 2007

FDA's hefty bonuses seek to retain workers

In today's Philadelphia Inquirer the following story describes financial incentives being given to FDA workers to entice them not to abandon ship for industry or other higher-paying jobs.

I believe one of the biggest problems causing such people to want to leave is bureaucracy and wooden-headed leadership, not primarily salary. As per my previous posts at at "Computer debacle: a Broken down process at the agency - or beyond?", at "Report: Life Science Manufacturers Adapt to Industry Transition" and at "Drug industry officials see room to improve safety - or do they?", among others, I can imagine FDA is probably a very difficult workplace for critical-thinking scientists with integrity (David Graham is one example in FDA's Office of Drug Safety of an iconoclast who survives, but he seems to have had the protection of a U.S. Senator named Grassley.)

I am also dubious about exactly who is being awarded the bonuses, and who made the decisions, and on what metrics. (Did Graham get a bonus?)

I also fear that the "hefty bonuses" will probably be inadequate to compensate for the environment, however, where good scientists are concerned.

FDA's hefty bonuses seek to retain workers

July 17, 2007
By Andrew Bridges
Associated Press

WASHINGTON - The Food and Drug Administration is giving workers more than $8 million in bonuses to keep them from defecting to pharmaceutical and other regulated industries at the same time the agency is being pressed to spend more on food and drug safety.

The retention bonuses, worth $5,000 or more per employee, are almost triple what it paid in 2002 and more than any other federal agency pays. As recently as 2005, the FDA accounted for more than 40 percent of the overall $21.6 million Washington paid in retention bonuses, according to government records.

The retention bonuses are part of an overall financial incentive program, including recruitment and relocation bonuses, that has grown sharply. In 2002, the FDA gave out just $3.2 million in bonuses worth $5,000 or more. That grew to $9.5 million last year.

Agency officials say the bonuses are necessary to keep vital employees from moving to the private sector; critics say the money would be better spent on improving safety.

... "Congress puts in extra money for food safety and what does FDA spend it on? Bonuses," said Rep. Bart Stupak (D., Mich.), chairman of the oversight and investigations subcommittee of the House Committee on Energy and Commerce.

... The FDA has long complained about turnover in its Centers for Drug Evaluation and Review, especially among medical officers. Agency officials contend the incentives help recruit new employees and, more importantly, encourage veterans from leaving for drug companies, universities, law firms and others that value their decades of experience and sought-after technical expertise.

In my own experience, I'm not sure FDA should promote people to be staying around, especially at senior levels, if my personal interaction several years ago with a former senior FDA drug safety official was any indication. (I interacted with Martin H. Himmel MD, MPH, former Deputy Director, Office of Drug Safety, CDER, FDA, now at Merck as an Executive Director in Clinical Risk Management & Safety Surveillance. It was not pleasant, with Dr Himmel seemingly going out of his way to humiliate and demean):

In the interview at Merck in a rehire situation about a year after the mass layoffs of Nov. 2003 ("Equinox" layoffs, 4,400 separated, myself included), I came highly recommended by a less senior Executive Director in the same department, to whom I had shown my prior work. This included well-accepted, novel human-computer interaction designs I'd developed for use by busy biomedical researchers for a large clinical study in the Middle East , as well as my work modeling invasive cardiology and leading the development and implementation of a comprehensive information system to detect new device and treatment modality risks in a regional center performing more than 6,000 procedures/year. In addition, I'd worked with the wife of the less senior Executive Director in years prior, when she ran the E.R. of the hospital where I was director of occupational medicine.

Despite all this in my favor, Himmel, himself former Deputy Director, Office of Drug Safety, CDER, greeted me not with a traditional "hello" or other socially appropriate greeting, but instead by asking sarcastically "what I had been up to since the layoffs" ("looking for a job, moron", I thought to myself) and then dismissed me in five minutes as I was showing him the cardiology project, saying flatly "we don't need a medical informatics person here."

I had driven 80 miles to Rahway for this interview to save the executive a trip to Pennsylvania, where I was originally scheduled to come for the interview, since Himmel's father was supposedly ill in the hospital. In an instance of profound social ineptness, my effort was not even acknowledged. Perhaps he was in a bad frame of mind, but the rude dismissal under the circumstances was all the more disappointing.

This was even less excusable considering that the Institute of Medicine of the National Academies, as I observed at "IOM gets it regarding Medical Informatics", recommends:

... that CDER [FDA's Center for Drug Evaluation and Research] build internal epidemiologic and informatics capacity in order to improve the postmarket assessment of drugs. In recognition of the limitations in human resources in the current employment market to meet this role, a combination of advancing professional skills through continuing education and support for academic training programs is needed.

and that

Informatics experts should track progress on the national health-information infrastructure, look for opportunities to gather information about drug safety and efficacy after approval, coordinate partnerships with external groups to study the use of electronic health records for [drug] adverse event surveillance, participate in FDA’s already strong role in setting national standards and track the development of tools for data analysis in industry and academe, and encourage the incorporation of the tools into FDA practice where appropriate.


I believe FDA would likely be better off paying some people to leave for industry, not awarding them retention bonuses to stay, with the "short timers list" prepared by people like Graham.

A purge might restore FDA to a higher level of usefulness and integrity.

And perhaps leading to less need for stories such as "Avandia to be Reviewed by FDA Board with Conflicted Members" immediately preceding this story.

-- SS

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