3-Mar-10 10:00 AM CST
FDA, NIH Join Forces
In hopes of accelerating the approval process of new and emerging medication therapies, the FDA and the National Institutes of Health are officially teaming up for the first time to form a joint leadership council.
The Joint NIH-FDA Leadership Council will be a committee of six of the top scientists from both agencies and co-chaired by Dr. Francis Collins, head of the NIH, and Dr. Peggy Hamburg, head of the FDA. Dr. Collins and Dr. Hamburg were the ones who proposed the creation of the council. The council will work to improve the efficiency and speed of the research and regulatory process of advancing new drugs.
“The first step for many medicines on their way to our pharmacy shelves is a discovery in an NIH-funded laboratory. The last step for all of them is a careful analysis at the FDA,” said HHS Secretary Kathleen Sebelius, who announced the new partnership last week at a press conference in Bethesda, Maryland. “We’re here today because we know we can deliver these treatments faster and safer if these agencies strengthen their partnership, working not just side by side, but also hand in hand.”
The key focus of the new partnership will be to advance and develop testing technologies and other tools federal regulators use to analyze the risks and benefits of drugs being processed for approval. Better technology will help increase the speed and efficiency of the approval process and help pharmaceutical researchers and manufacturers release new drugs to the public faster. The FDA and the NIH also hope that direct collaboration will help drug developers better navigate through the regulatory process. Secretary Sebelius also hopes the partnership will help speed up the advancement of treatments in biomedicine and personalized medicine done through genetic mapping.
“Today, some of our most promising new treatments are based on emerging technologies like cell-based and targeted small molecule therapies,” Sebelius said. “From early in development, basic researchers at NIH should be sharing information about these technologies with scientists at FDA to help them develop standards for safety and effectiveness.”
In addition to the formation of the new joint council, the FDA and the NIH announced that they will collectively be making $6.75 million in grants available over the next three years for research on regulatory science. They are also planning a public meeting in the spring to encourage feedback from all parties involved in the research and development of new medicines and treatments, though an official date has yet to be announced.
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