Healthy Skepticism Library item: 855

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Publication type: news

Henderson D.
FDA piles initiatives on the back burner: Pressing drug safety problems divert the agency's attention from longer-term issues awaiting action
The Boston Globe 2005 Mar 10

Full text:

Acting Food and Drug Administration commissioner Lester Crawford has been so busy putting out fires on drug safety that other unfinished business has piled up.

For months, the agency has been finalizing a drug safety plan to identify people most at risk for serious side effects while keeping a drug on the market. In a National Press Club speech in August, Crawford set a six-month deadline for such goals as providing instructions to the food industry for labels on low-carbohydrate products and strengthening restrictions on animal feed to protect against mad cow disease.

Those efforts, some former agency officials and consumer advocates say, have fallen victim as FDA resources were diverted to more pressing issues.

‘‘Whenever you have a series of crises, as they’ve had this year in the drug safety area, they tend to overwhelm and attract the attention of all the senior management,” said William W. Vodra, a former FDA attorney now with the Washington, D.C., office of Arnold and Porter. ‘‘So keeping on with longer-term initiatives is a real challenge.”

The agency acknowledged its unfinished business includes significant initiatives that it expects to complete shortly.

The ‘‘FDA is diligently working on each of these important issues,” said Kathleen K. Quinn, FDA’s media relations director.

Quinn declined to comment further and said Crawford was not available for an interview.

Crawford canceled testimony yesterday before members of Congress who will write the section of a bill that provides funds for the agency’s 2006 budget.

US Representative Maurice Hinchey said he would have pressed Crawford on what Hinchey says is poor leadership and allegations that Crawford silenced critics within the FDA who pointed to unsafe drugs while permitting inappropriately close ties to the drug industry.

‘‘The consequences of that are being borne by the American people, including serious illness and death,” Hinchey said.

The New York Democrat has drafted legislation that would funnel drug industry funding for the FDA through the US Treasury to create distance between the industry and its regulator.

Currently, companies pay fees directly to the FDA for drug approval expenses.

In addition, Hinchey said he would create a completely independent center to police drug safety with the power to pull unsafe drugs from the market. And he’ll seek higher overall drug safety funding so early warnings aren’t missed.

‘‘What we’ve seen is often within these clinical trials, red flags are raised. Frequently, many of them. But even though somebody in the FDA sees the red flag, they don’t look behind it to see what the problem is,” he said.

Various members of Congress already are considering changes, including restrictions on drug advertising, requiring larger safety drug studies, and giving the FDA authority to immediately change labels for unsafe products.

Unilateral authority would shift power to the FDA as it revises labels for such painkillers as Bextra, Celebrex, and Vioxx, linked to heart attacks and strokes.

Right now, such changes occur after lengthy negotiations with manufacturers, which critics say weakens warnings.

The FDA, however, could sidestep such problems if it knew earlier which patients were likely to suffer serious side effects. A trio of draft plans to reduce such drug risks have languished since last summer as the FDA grappled with pressing safety issues linked to antidepressants used by kids and painkillers popular with millions of Americans.

‘‘If we can identify the patients who are most at risk of gastrointestinal problems and least at risk for cardiovascular problems, they’re the ideal ones for” painkillers like Celebrex, Vodra said. ‘‘That’s what this whole risk-management initiative is about.”

He said FDA senior management has been so consumed with immediate crises that such long-term solutions have been delayed.

‘‘It’s hard to think about draining a swamp when you’re up to your butt in alligators,” he said.

One potential solution is knowing precisely why some drugs are more dangerous.

Moving in that direction, the FDA signed an agreement with Applied Biosystems, the company said yesterday, for molecular sleuthing on five diabetes drugs, including Rezulin, to reveal the reason for liver toxicity that forced that drug from the market.

With food, as with prescription drugs, safety experts say the FDA has made scant progress on significant initiatives.

Last August, Crawford said the FDA was considering barring from all animal feed risky material, like cow’s blood, thought to harbor the agent that causes mad cow disease.

The FDA’s move would provide ‘‘an added assurance of safety for our food supply and other products we all use that are manufactured with bovine-derived materials,” Crawford told a National Press Club audience.

Seven months later, FDA’s improved protections for animal feed have neither been proposed nor implemented.

‘‘The failure of FDA to move forward on the animal feed improvement might have been a waiting game,” said Caroline Smith DeWaal, food safety director at the Washington, D.C.-based Center for Science in the Public Interest. ‘‘It’s clear the industry pressure on this issue has really paid off.”

The National Cattlemen’s Beef Association has few concerns about the delay, said Gary Weber, executive director of regulatory affairs for the trade group.

He added that the industry has not pressured the FDA to delay.

Food safety experts pointed to a number of recent FDA actions that bolster food safety and security, including registering American food processors, requiring prior notice of foods to be imported, detaining suspect food until inspectors clear it, reducing hazards posed by fresh juice, and, for the first time, spelling out activities on farms to ensure fresh fruit and vegetables are safe.

But other initiatives await action. In his August speech, Crawford said that consumers are confused by the term ‘‘low carb.”

As the low-carb craze ebbs, however, the FDA has still not given industry guidance that Crawford said would ‘‘demystify” carbohydrate claims on food labels.

‘‘We are still waiting for that,” said Robert Earl, senior director of nutrition policy at the Food Products Association, which represents the $500 billion food-processing industry.