FDA News
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FOR IMMEDIATE RELEASE
P04-74
August 2, 2004
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Acting FDA Commissioner Outlines Priorities for Next Six Months
At the National Press Club “Newsmaker Luncheon” today, Dr. Lester M. Crawford, Acting FDA Commissioner outlined the agency's priorities and important anticipated major actions in the next six months. He focused on Technology Development and Innovation, Modernizing the Health Care System through GMPs, Increasing Access to Important and Life-Saving Technologies and Patient and Consumer Protection and Education.
“The next six months will be a critical period in which FDA plans to take important steps forward to strengthen public health and build on our accomplishments in the recent past,” said Dr. Crawford.
Highlighted below are major actions Dr. Crawford outlined today.
In the area of Technology Development and Innovation:
- As chair of a Health and Human Services (HHS) wide taskforce on medical technology innovation, Dr. Crawford intends to host a series of public roundtables in September to help streamline and promote faster access to new medical technologies. The task force recommendations will be sent to Secretary Thompson by the end of the year.
- FDA recently signed a contract with the Keystone Center to convene and
facilitate a national dialogue on obesity. Through this dialogue, FDA will
finalize the restaurant and consumer education recommendations from the Calories
Count Report.
- As part of FDA's Critical Path initiative, the agency is reviewing comments to the public docket regarding this initiative and gaining insight on current hurdles to therapeutic product development. FDA hopes to announce by late Fall the agency's first National Critical Path Opportunities List that will pinpoint areas of product development that could most benefit from innovative approaches and emerging technologies.
In the area of Good Manufacturing Practices (GMPs):
- FDA is working to ensure that the latest, science-based current good manufacturing practices (cGMPs) are in place to help ensure product quality across all industries FDA regulates. August will mark the two-year anniversary of the Drug cGMP initiative and this project will be completed by this fall.
- FDA's Food GMP Modernization Working Group is holding a series of public meetings this summer and fall in order to issue draft guidance to industry by year's end. FDA is also planning to finalize the first GMP guidance for dietary supplement manufacturers by this coming winter.
In the area of Increasing Patient Access to Important and Life-saving Technologies:
- FDA will continue to make the Generic Drug program a top priority in order to help make lower-cost, high-quality medications available to as many people as possible.
- FDA is moving ahead on a new proposed rule for expanding the treatment use of investigational drugs for patients facing serious and life-threatening diseases.
- FDA is expediting global access to treatments for HIV/AIDS. The agency has issued guidance and is providing technical assistance to help to ensure that the U.S. is providing safe, effective drugs to developing countries under the President's Emergency Plan for AIDS Relief. Two new fixed-dose combinations to treat HIV/AIDS have just been approved by FDA. These new products will allow a dosage regimen of one pill per day and will have great utility for patients in remote areas.
In the area of Patient and Consumer Protection and Education:
- FDA will be finalizing the agency's proposed changes to prescription drug labeling to make the label more user-friendly for both patients and health care practitioners. These revisions will help reduce medication errors.
- FDA will announce by the end of the year new steps to combat food-borne illness and bolster safeguards against mad cow disease. In the coming months, FDA will be proposing a new, landmark regulation to stop the spread of Salmonella enteritidis through shell eggs. For mad cow disease, FDA will be working to finalize rules on human food, complete regulations on medical products, and consider additional safeguards for animal feed, such as imposing a ban on the use of specified risk material in all animal feed.
- FDA published the report of its Obesity Working Group in March that recommended a number of measures to counter this growing problem. As a result, FDA is reviewing ways to enhance the food label, educate consumers, and find better treatments for obesity. In addition, the agency is working with the restaurant industry to find ways to provide better nutritional information to patrons.
- FDA will be publishing a proposed rule later this fall to provide guidance to manufacturers regarding nutrient content claims related to the carbohydrate content of foods.
- FDA also intends to move forward on the recommendation to give prominence to calories and serving size on the food label including proposing to increase the font size and provide a daily value percentage for calories.
- FDA will establish a new inter-center coordinating group to facilitate the development and implementation of new policies related to the promotion of medical products within FDA's jurisdiction.
A full copy of Dr. Crawford's speech today can be found at: http://www.fda.gov/oc/speeches/2004/newsmaker0802.html.
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