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Commentary

F.D.A. Moves Toward More Openness With the Public
Gardner Harris, The New York Times, 2-20-05

The FDA advisory committee meeting on COX-2 inhibitors and other older painkillers was not, perhaps, as explosive as some had expected. Harris praises the agency for adopting a culture of openness, and allowing disagreements within the agency—particularly between staffers who guide the drug approval process and those who monitor patient safety, to be aired in public.

“These changes were not voluntary. The F.D.A. has been forced by a series of embarrassing scandals over the past year to transform its “Daddy knows best” culture. An unrelenting investigation by Senator Charles E. Grassley, Republican of Iowa, has made creating a new agency culture a matter of political survival. The new secretary of health and human services, Michael O. Leavitt, has championed the changes, promising to bring “transparency” to the agency, a vow echoed by Dr. Lester M. Crawford, the agency’s longtime acting chief who was nominated this week as permanent commissioner.”

Transparency is important for other reasons as well—namely a patient’s right to control their own health care decisions. As patients learn more about prescription drugs, they will increasingly understand that no drug is completely safe, and that they need to become more active participants in their own health care.

As they become more comfortable with that control, they will be less prone to panic whenever a rare drug interaction or adverse effect surfaces. More transparency at FDA is more than welcome in an age of consumer driven health care, and FDA regulation should adapt accordingly to ensure that more power and control—along with better information—is passed along to patients and their doctors.



Project FDA.
  
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