Published April 25, 2011 in Washington Drug Letter
JERSEY CITY, N.J. — Due to increasing pressures from Congress, the NIH is moving away from funding basic medical research and shifting toward translational work, a field once reserved for the pharmaceutical industry.
The results will show in a few years with even fewer products in the development pipeline for drug companies, former Merck CEO J. Roy Vagelos said at PhRMA’s 2011 Annual Meeting, held here April 14.
“The end result of this is we’ll have less new knowledge at a time when science is booming,” Vagelos said.
The change has come from Congress, which is dissatisfied with the number of drugs the NIH has been developing, he added.
And statistics show the FDA has been approving fewer drugs. The FDA approved just 21 new molecular entities last year, the lowest level since 2007 when 18 were approved.
To get additional funding from Congress, the NIH has shifted its funding focus. Vagelos said academia and scientists funded through NIH grants aren’t as good at translational work and applied research as pharmaceutical companies, which have developed the skills necessary to transform products from drug candidates to market.
“We’re on a pathway to destruction as far as I see,” Vagelos said, alluding to the possibility NIH may be misspending money.
Former Eli Lilly CEO Sidney Taurel also suggested that industry, not NIH-funded academic scientists, should work on translational medical research.
Earlier at the PhRMA meeting, different industry leaders criticized the FDA for lagging in regulatory science, claiming the slow efforts are limiting new drug development.
In 2006, the NIH implemented clinical and translational science awards, which sought to fund up to $500 million annually to academic health centers for translational medicine (WDL, Oct. 9, 2006).
The plan was started by former NIH Director Elias Zerhouni. Other PhRMA panel members said additional emphasis on translational research has only gotten worse under current Director Francis Collins.
Last February, the NIH and FDA created the Joint NIH-FDA Leadership Council, an effort to ensure regulatory considerations are integrated into research planning and science is rolled into the regulatory review process. Collins, FDA Commissioner Margaret Hamburg and CDER Director Janet Woodcock, among others, sit on the 14-member council.
FDA Chief Scientist Jesse Goodman, speaking at an FDA Science Board meeting in November, said the panel has established working groups within the two agencies to prioritize potential high-impact areas.
“There was a lot of interest in how we could work together around the repurposing of products that are not being used or that have dropped through the commercial development system,” Goodman said. “And FDA and NIH have both been very interested in this and are already working together.” — David Pittman