FDA drug review proposal draws critics at BIO Convention

As more than 15,000 life sciences professional converged on Boston Monday for the Biotechnology Organization’s annual convention, a Food and Drug Administration plan to make regulatory decisions on new drugs more transparent drew criticism from some industry members.

“For my money, this is kindergarten,” groused Vladimir Shnaydman, president of Orbee Consulting, an Ashland firm that advises life sciences companies. “They move too slowly, and this is very disappointing.”

The goal of the FDA’s proposed “benefit-risk framework,” which has been in the works since 2009, is to improve the consistency of the agency’s review criteria for new drug candidates and make them easier to communicate, said Patrick J. Frey, director of planning and analysis at the FDA’s Center for Drug Evaluation and Research.

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Under the proposed criteria, FDA reviewers would describe a medical condition and its clinical manifestations, list other therapies used to treat it, assess effectiveness and safety, and compare them with the experimental drug.

Frey said the FDA currently has no formal benefit-risk format.

“Oftentimes, the table can be littered with benefit-risk considerations,” he said. “But when you boil them down, this is what really matters.”

Shnaydman and others called on the FDA to make more quantitative decisions on drug candidates, arguing that data-driven decisions are common in other industries.

But while FDA regulators are willing to quantify the “magnitude of risks and benefits,” Frey said, “ultimately, it’s a qualitative assessment.”

Brian G. Atwood, managing director of Versant Ventures in Menlo Park, Calif., said the FDA criteria should be simple enough to communicate to members of Congress and the media who, he said, can derail new drugs by focusing on safety problems.

“Bomb throwers and the media really hurt the industry,” Atwood said. “You need to find some way to immunize the industry.”