The U.S. Food and Drug Administration has taken a big step forward in ensuring not only the safety of millions of consumers, but also in monitoring the activities of companies manufacturing potentially harmful drugs.
The FDA last week created the Drug Safety Oversight Board in response to revelations that using common prescription drugs, including Vioxx and several over-the-counter products, offered potential health threats. Vioxx, which received its FDA approval in 1999, was pulled off the market last fall. Doctors also have been warned that prescription medications Celebrex and Bextra should only be prescribed in limited situations.
That the agency acted so quickly comes as a relief, but giving the board comprised primarily of FDA and other government scientists as well as outside experts direct access to acting Commissioner Lester M. Crawford reveals this isn’t the standard bureaucratic response to resolve a very serious problem. A direct pipeline should give the board a sharp set of fangs in dealing with mounting concerns regarding the safety of both over-the-counter and prescription medications.
The panel’s creation also signals a new era for the FDA, whose oversight of the pharmaceutical industry can best be described as passive. In announcing the panel’s creation last week, Health and Human Services Secretary Mike Leavitt said his goal is to instill the FDA with a culture of openness, independence and maintain a commitment to monitor drugs after they have been approved.
The agency’s grit will be tested almost immediately, as it faces questions on what to do with arthritis drugs Celebrex and Bextra, which provided drug maker Pfizer Corp. with some $5 billion in worldwide revenue in 2004.
Drug manufacturers may face even more stringent supervision in the near future. There is talk of legislation to create an independent drug-safety office and launch a public registry for clinical trials normally run by the drug companies.
With consumer confidence understandably shaken and the FDA’s credibility on the line in the wake of the Vioxx debacle, such sweeping changes for the agency come none too soon. The Drug Safety Oversight Board’s debut is a good first step in providing the agency with the proper tools to monitor the public’s health and well-being.
, Rick Bell
