FDA Initiative Aims to Speed Development of New Medicines

NIH and the FDA have announced a partnership to speed theFDA development of new medicines and make them available to patients as quickly as possible. By increasing communication between the two and funding new research on the science behind product evaluations, officials from both agencies believe the initiative can shorten the time between discoveries in the laboratory and their translation into safe and effective therapies for patients.

“We want to accelerate and illuminate the pathway from microscope to market,” said Health and Human Services (HHS) Secretary Kathleen Sebelius at a briefing on February 24. She noted that many promising new treatments for cancer and other diseases are based on emerging technologies, and in some cases the FDA has little experience evaluating these treatments.

The initiative aims to address this issue in part by enhancing communication between scientists at the FDA and NIH. A Joint Leadership Council could, among other responsibilities, ensure that regulatory considerations are a component of planning for biomedical research and that the regulatory review process includes the latest science.

As Secretary Sebelius noted, NIH researchers who have expertise on a particular technology could help FDA scientists develop standards for evaluating therapies based on that technology. Similarly, FDA scientists could alert researchers about which safety issues would be important to win approval for therapies involving certain technologies.

In addition, $6.75 million will be spent over 3 years to support research on regulatory science. The grants will fund projects on new methods, models, or technologies that will inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical products.

“This is an unprecedented effort to put together the leadership of NIH and FDA in a way that will catalyze the development of new therapeutics in ways that will benefit the public as quickly as possible,” said NIH Director Dr. Francis Collins.

In recent decades, biomedical research and discovery have evolved greatly, and regulatory science must also evolve, noted FDA Commissioner Dr. Margaret Hamburg. “This has created an imbalance that cannot persist,” she added.

Leaders of the initiative will seek comments from the public, the advocacy community, and scientists on the best ways to advance the goals of the initiative. A meeting could take place this spring.

First Meeting of FDA Tobacco Products Advisory Committee Announced

The first meeting of the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) will be held on March 30–31 in Washington, DC, the agency announced last week. The committee’s formation was mandated under the Family Smoking Prevention and Tobacco Control Act, which President Obama signed into law last June.

Also announced were the nine voting members of the advisory committee. The committee will include three nonvoting members who represent different components of the tobacco industry, but those members have yet to be selected, the FDA noted in a statement. Dr. Jonathan Samet of the University of Southern California’s Norris Comprehensive Cancer Center will chair the committee.

“FDA will be faced with many challenging tobacco-related public health, science, and regulatory issues as we move forward with implementation of the Tobacco Control Act,” said Dr. Lawrence R. Deyton, director of the FDA’s Center for Tobacco Products, in a statement. “The breadth of knowledge amassed by this highly-qualified group will supplement and enhance the agency’s understanding of tobacco control, prevention, and health promotion issues.”

The advisory committee’s first meeting will focus on menthol, a common additive in cigarettes. Although the Family Smoking Prevention and Tobacco Control Act banned the addition of candy-like flavorings and certain other additives to cigarettes, menthol was not part of that prohibition. The law did, however, direct the TPSAC to deliver a report to the HHS secretary on the public health impact of menthol cigarettes, and, based on the report’s findings, the FDA has the authority to take further regulatory action with regard to menthol.

Presentations at the March meeting will cover a broad array of research on menthol cigarettes, such as the demographics of menthol cigarette users, the influence of these demographics on smoking initiation, and menthol’s effect on how cigarettes are smoked.


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