Top scientists at the National Institutes of Health and the Food and Drug Administration will be working together more closely in an effort to improve the regulatory process and bring new treatments to market sooner.
With more new treatments based on emerging technologies, NIH and FDA scientists must communicate with each other earlier and more often, explained Kathleen Sebelius, secretary of the Department of Health and Human Services. From the beginning of a therapy's development, basic scientists at the NIH should share information with the FDA so that FDA regulators can develop appropriate safety and effectiveness standards early on.
At the same time, FDA scientists can help researchers identify possible safety or quality issues earlier in the process, Ms. Sebelius said during a news conference to announce the partnership.
“By communicating throughout the process, it will help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment's risks and benefits,” Ms. Sebelius said. “For Americans, this is going to mean that new treatments are available sooner.”
The initiative calls for the creation of a joint FDA-NIH Leadership Council that will include FDA commissioner Dr. Margaret A. Hamburg and NIH director Dr. Francis S. Collins, as well as six senior scientists from each of the two agencies. In addition, the NIH and the FDA have pooled their resources to offer $6.75 million in grants during the next 3 years for research on regulatory science. For example, the agencies are looking for ideas on how the FDA would evaluate the safety and effectiveness of new stem cell therapies.
Government officials will be seeking public comment on how the two agencies can improve their collaboration. The NIH and the FDA will hold a public meeting jointly this spring to gather input from industry, patient advocates, and the public.
To bring safe, effective therapies into the market sooner, the science used to develop new therapeutic compounds must be closely connected to the science that the FDA uses to review those compounds, Dr. Collins said.
But that hasn't always been the case, he added. Researchers have not always shared information with the FDA early in the process, leaving the regulators to evaluate medicines without the data they need. Meanwhile, academics sometimes have expressed concern that the FDA lacks understanding about certain aspects of novel therapies, Dr. Collins noted.
Bridging that gap will be essential, he said, as the FDA is asked to evaluate more combination therapies and medicines developed under the umbrella of personalized medicine.
“The science that undergirds this kind of regulatory effort could certainly use some additional energy,” Dr. Collins said.