Regulatory Focus™ > News Articles > 2019 > 7 > FDA’s Woodcock Weighs in on Role of NIH in Drug Development

Regulatory NewsRegulatory News
Posted 24 July 2019 | By Zachary Brennan 

FDA’s Woodcock Weighs in on Role of NIH in Drug Development

2962 US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Director Janet Woodcock said Wednesday that while the National Institutes of Health (NIH) has been instrumental to drug discovery and development, she does not think NIH or academics should be in the business of developing new pharmaceuticals.

The comments came as part of the first day of a two-day meeting at the National Academies of Sciences, Engineering and Medicine in Washington, DC, on the role of NIH in drug development innovation and the impact on patient access.

While noting that NIH research “has served biomedicine very well,” Woodcock also explained how NIH’s work is heavily geared toward the early stages of development, with a relatively small amount of expertise on bringing drugs to market.

“The NIH enterprise is necessary and generates a huge knowledge machine to move the field ahead and generate scientists that work at FDA, industry and academia,” she added, noting that science is a team-based endeavor and not about a single investigator.

She also criticized the pharmaceutical industry for building walls around information that could help the biomedical ecosystem and patients.

“The translational realm is left to the pharmaceutical industry, which doesn’t share information,” she said. “I really think you need a lot of inter-disciplinary activity and NIH has been successful with public-private partnerships with common objectives and everything is made public.”

But on the topic of how much NIH contributes to drug development overall, which is a question that’s been brewing for years, she said she thought the arguments were “ill-placed.”

“We need to think about human health,” Woodcock said, adding that the “idea should be how to make this process effective and how to make it work for patients.”

She also called for the drug development process to be re-engineered, using the examples of the airline and construction industries. “Usually they can build an airplane and it can fly the first time,” she said, noting that it’s the same for bridges and skyscrapers working when they are first built. “We have to engineer this so it’s not trial and error every time.”

In addition to Woodcock’s comments, other discussions Wednesday dealt with patent and technology transfer policies and strategies to facilitate the translation of federally funded biomedical research into drug development and commercialization. Thursday’s sessions will deal with drug pricing and strategies and policies to ensure affordable access to medicines.

The Role of NIH in Drug Development Innovation and its Impact on Patient Access: A Workshop


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy
No data found