Tennessean Editorials, Opinions Discuss FDA Investigation Drug List

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Public Health;  Pharma Industry / Biotech Industry
Article Date: 13 Oct 2008 - 11:00 PDT

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The Tennessean on Thursday published an editorial and two opinion pieces about an FDA decision to publish online a quarterly list of drugs being investigated for potential safety risks. Summaries appear below.

Editorial
Concerns that "some patients will overreact" and stop taking a medication if they see it on the FDA list "may have some foundation," but "FDA will never be in position where people are fully satisfied with every aspect of drugs in use," a Tennessean editorial states. According to the editorial, "In time, the FDA watch list should become as comfortable and useful to patients as the labels on food," which consumers have found "advantageous." The Tennessean continues, "If any medication is potentially harmful, everyone should know. But health officials should never be afraid of sharing the best available information." The editorial concludes, "The new drug listings are responsible and fair. Ultimately, the step should prove to bolster, not undermine, patient confidence" (Tennessean, 10/10).

Opinion Pieces

• Lawrence Brown, Tennessean: While the list will give "patients more power over their health care," it does not go "far enough," Lawrence Brown, a pharmacist, writes in a Tennessean opinion piece. According to Brown, "A system should be put in place that increases the likelihood health-care providers and patients will know about the list, because it can't do any good if nobody knows about it." Brown says that FDA should contact professional health associations "and encourage them to promote the site to their members," include the quarterly information in continuing education programs, encourage physicians and pharmacists to post the information where patients can see it, and create a master list that includes an alphabetical listing of the medications being investigated (Brown, Tennessean, 10/10).
  
  
• Dan Roden, Tennessean: The FDA list appears "to be in the public interest," but the move "raises important issues about how doctors and patients should evaluate new information about the risks and benefits of drugs," Roden, a physician, writes in a Tennessean opinion piece. Roden says that a "potential benefit" of publicizing adverse-event reports is that "[s]uggesting tenuous relationships between drugs and unusual side effects may prompt other physicians or consumers to recognize that they, too, may have seen (or been) similar cases." In addition, he writes that he sees "an opportunity for coupling this kind of reporting to increase public awareness of the risks vs. benefits of treatment with any drug" (Roden, Tennessean, 10/10).

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