Don't "Blow Up" FDA

Biopharmaceutical companies no longer consider FDA an obstacle to innovation and in need of major reform, according to leading observers of the drug regulatory process. “We now have clear expectations about review times,” said Jim Greenwood, president of the Biotechnology Innovation Organization (BIO), at a forum sponsored by the Bipartisan Policy Center. So we “don’t need someone saying this place is a disaster and let’s blow it up.”

What is important, said former FDA commissioner Andrew von Eschenbach, is to provide FDA with the scientific knowledge and expertise it needs to be able to do its job appropriately, and not to undermine the scientific basis of drug regulation. At the same time, he observed, FDA needs a process to look at the need for systemic reform that will ensure that new products are “appropriately regulated.”

The main issue for companies developing new drugs is not too-slow application reviews, Greenwood added , but that it “takes too much time to get to FDA.” Research sponsors need new biomarkers, patient-centered tools, and access to Big Data to accelerate research and to improve clinical trial operations.

Greenwood and von Eschenbach joined with Ellen Sigal, chair of Friends of Cancer Research, and Mary Woolley, president of Research!America, in urging Congressional enactment of the 21^st Century Cures legislation during the lame duck session of Congress coming up. The bill would provide more funds for biomedical research and improvements in FDA policies, Sigal noted, and also would address the agency’s difficulties in attracting and retaining “the best people.” Passing the bill now, said von Eschenbach, would set a foundation for how the new administration addresses policy issues, such as proposals for FDA to become an independent agency and to create new long-term funding strategies for the National Institutes of Health.

NIH director Francis Collins also backed action on the “Cures” bill, which would give NIH added resources and flexibility to take certain actions more quickly, he said at the forum. Collins addressed how the nation’s tremendous investment in biomedical research is now paying off, citing major advances in brain research and in developing new treatments for diabetes, cancer, pain, and infectious diseases.

Also important for innovation is to avoid pharmaceutical price controls, Greenwood said. Although the prospect of a war on pharma has diminished, he predicted that drug pricing issues “won’t go away.” He urged more collaboration among payers, patients and industry to establish a policy framework that is best for all pa ties and doesn’t curb innovation.

Von Eschenbach expects more focus by the new administration on how to “spend better” to support biomedical research. New officials will be looking closely at how the federal research infrastructure is managed and the need for greater coordination among multiple agencies involved in research.