Independence Of FDA "Outside Experts" Questioned


When the Food and Drug Administration considers approval of a new drug or medical advice, it often turns to supposedly independent advisory review panels for guidance. But experts say that beginning in the early- to mid-1980s, the panels' independence began to deteriorate and the FDA now has the panels "pretty well trained."

Congress may look into this charge as it considers FDA reforms in coming months.

Here are some examples:

  • The president of a company making a sensor pad which enhances a woman's ability to detect lumps in her breast complains that "people don't read" the information he had to submit to the panel -- but worried instead about the pad's color, noise it made and costs, all of which were irrelevant to its performance and safety.

  • The founder of an AIDS group who testified in favor of a product which provides an oral test for HIV charges that an FDA panel composed of persons who had interests in blood banks and blood testing had a conflict of interest against the new product.

  • Early last year, an EPA panel member whose firm makes a prick-the-finger product for testing diabetics' blood sugar levels was involved in rejecting a new, noninvasive device which reads blood sugar levels using infrared technology.

  • The chairman of a panel reviewing a pioneering drug for Alzheimer's disease -- which was approved only after an arduous process -- was criticized in the trade press for a seeming bias against the product and for asking the panel to vote on questions that were not on the FDA's official list.

Source: Daniel J. Murphy, "Outside Experts or FDA Shills?" Investor's Business Daily, June 9, 1997.


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