FDA staff: Damned if they do and if they don't

Growing up in Bethesda, MD in the 70s and 80s I knew a lot of kids whose parents worked for the federal government. Most of my friends’ parents were scientists of one kind or another and they seemed pretty earnest and serious about their work –not like the Club Fed parodies in the media. When Ronald Reagan came in to office he appointed a bunch of agency heads who were anti-regulation —James Watt at Interior, for example. (At the time I remember my dad bought stock in Ralston Purina. He told me half-seriously that poor people would eat dog food after Reagan eliminated social programs. Ralston turned out to be a good investment although not for that reason.) But I digress…
One of the appointees at the time was Dr. Frank Young, who was head of the FDA. He was a very nice guy personally and we got to know his family since my brother and his son were on the high school wrestling team together. My mom used to make a cherry cheese cake, which used canned cherries that were a suspiciously even red. This was a few years after the Red Dye #2 scare and my parents felt a little sheepish when they realized they were serving this item to the FDA Commissioner at a dinner party. Anyway Dr. Young wasn’t too concerned about dangers from chemicals. He did mention that FDA was beginning to find rat feces in tuna from Asia, however.

At the time I remember a high school friend whose dad was a career FDA scientist, very frustrated with Dr. Young.

All this came to mind today when I read FDA Spending for Morale Boosting Draws Fire in the Wall Street Journal.

At a recent retreat for Food and Drug Administration employees, a slide show likened the agency’s top drug regulator, Janet Woodcock, to “visionary leaders” such as Golda Meir and Gandhi.

Some lawmakers are fuming about a $1.5 million contract for morale-boosting that the FDA awarded the consultant that prepared the slideshow. The agency’s problems, including questions about decisions on the safety of some popular medicines, are likely to come up in Senate confirmation hearings starting Thursday on Tom Daschle’s nomination to be secretary of Health and Human Services.

The slide show was presented at a management conference last month for nearly 500 employees of the FDA’s drug division, organized by the Center for Professional Development Inc., an Oakland, Calif., consulting firm. The meeting was part of a contract the division awarded to the consultant in late 2007 to “improve workplace leadership” and “empower staff” following a critical report by the Institute of Medicine, part of the National Academy of Sciences. The report faulted the division for sometimes ignoring FDA scientists’ concerns about drug safety, including their complaints that the division tilts toward industry in decision-making.

Rep. John Shimkus (R., Ill.) called the contract and the conference a waste. “To remove managers for two days to discuss this morale problem, instead of putting food and drug safety first, is ridiculous,” he said.

The FDA staffers are in a tough spot. They get pressure from industry and patient groups to approve drugs faster –or to approve drugs that may have problems. Meanwhile they get criticized by Congress and other members of the public when a drug they’ve approved does harm. FDA leaders make “podium policy” touting all sorts of things the Agency is supposedly doing, but the folks in the trenches have to be pretty brave to actually go along with these ideas.

FDA people I’ve met in the past few years have been particularly dedicated. Despite pretty poor working conditions and tight budgets they’re dedicated to patients. I’ve seen this particularly from the HIV/AIDS staff, some of whom have paid travel expenses out of their own pockets to get to key meetings for which they had no travel budget and couldn’t accept reimbursement from others.

I think FDA is completely reasonable in hiring this consultant and that Congress should lay off. I hope in the Obama Administration that life as an FDA or other agency staff member will improve and that the employees will be shown greater respect. That will be good for everyone’s health and make recruiting and retention of good people easier.

January 8, 2009

One thought on “FDA staff: Damned if they do and if they don't”

  1. The problem is the FDA does not disclose the problems (side effects) of so many drugs. They don’t requ8re drug companies to do so. They accept seriously flawed, methodologically and statistically, studies often done or supervised by those with financial interests. About 5 years ago they were found guilty of collusion with a pharma co in approving a drug that killed many due to liver failure. The revolving door between big pharma and the FDA is legion. In short, THE FDA IS CORRUPTED BY THOSE THEY’RE CHARGED TO REGULATE!!!

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