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A similar situation is brewing with baby formula following the reports of product made in China that was contaminated with melamine and linked to a thousands becoming ill and a handful of deaths. Further, there is a growing sense that Center for Food Safety and Applied Nutrition should be moved to the U.S. Department of Agriculture. Perhaps, but for this to proceed, serious thinking needs to go into two issues: The Dietary Supplement and Health Education Act and the regulation of dietary supplements as foods, and the issue of nutraceuticals and qualified health claims. Both are clearly FDA issues and should remain so.
Risk Communications
Rather than assuming the mantle of responsibility and proactively stepping forward with more regular and transparent risk communications programs, the FDA was driven by the winds of crisis. Today, the agency has implemented certain programs (some required by Food and Drug Administration Amendments Act) that provide risk information—but without any context, rhyme or reason. The result is confusion among patients and physicians and a field day for the media. The unintended consequences have swamped the public health benefit. Senior agency leadership knows it—but what are they doing to address it? The answer is not clear. A good beginning would be for the FDA’s Risk Communications Advisory to look into the matter. This problem needs to be fixed as noone (not industry, not doctors, not patients,) is happy with the current state of affairs.
Rather than assuming the mantle of responsibility and proactively stepping forward with more regular and transparent risk communications programs, the FDA was driven by the winds of crisis. Today, the agency has implemented certain programs (some required by Food and Drug Administration Amendments Act) that provide risk information—but without any context, rhyme or reason. The result is confusion among patients and physicians and a field day for the media. The unintended consequences have swamped the public health benefit. Senior agency leadership knows it—but what are they doing to address it? The answer is not clear. A good beginning would be for the FDA’s Risk Communications Advisory to look into the matter. This problem needs to be fixed as noone (not industry, not doctors, not patients,) is happy with the current state of affairs.
The Drug Label and the “Safe Use” of Drugs
The drug label is the single most important piece of communications material the agency issues—and it isn’t working as well as it should. The New Physician Labeling Rule (January 2006) has had minimal impact for three main reasons: It has not been widely adopted for products licensed prior to the rule (not a requirement, but an option); there has been little agency outreach to physicians and; there has been no broader agency program on the issue of “safe use.” This last point will change in January when the FDA (via the Center for Drug Evaluation and Research) launches a more comprehensive “safe use” initiative. The agency must consider not just safety, efficacy and quality—but safe use as well. Not just drug safety, but patient safety. This makes perfect sense and gives the FDA the opportunity to speak not only to physicians, but to consumers as well. The program should be expanded to also include medical devices. It is a timely, important, and urgent opportunity and must be done with determination, creativity, and relentless passion. It must be the FDA on the offense for the public health. And the offense must never stop.
The drug label is the single most important piece of communications material the agency issues—and it isn’t working as well as it should. The New Physician Labeling Rule (January 2006) has had minimal impact for three main reasons: It has not been widely adopted for products licensed prior to the rule (not a requirement, but an option); there has been little agency outreach to physicians and; there has been no broader agency program on the issue of “safe use.” This last point will change in January when the FDA (via the Center for Drug Evaluation and Research) launches a more comprehensive “safe use” initiative. The agency must consider not just safety, efficacy and quality—but safe use as well. Not just drug safety, but patient safety. This makes perfect sense and gives the FDA the opportunity to speak not only to physicians, but to consumers as well. The program should be expanded to also include medical devices. It is a timely, important, and urgent opportunity and must be done with determination, creativity, and relentless passion. It must be the FDA on the offense for the public health. And the offense must never stop.
There are many more issues (a more thoughtful position on expanded access, United States-European Union regulatory harmonization, and more). I look forward to working with the transition team to ensure that the new commissioner can hit the ground running—in the right direction—with some early and important wins that will set the tone for a newly confident FDA.
(Note: All information provided the various transition teams are available at www.change.gov.)
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.
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December 17, 2008
http://www.burrillreport.com/article-my_two_cents_for_mr_obama.html
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