FDA proposes controversial release of complete response letters

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After a long-simmering controversy over regulatory transparency, an FDA task force has proposed releasing its complete response letters to drug developers as part of a wide-ranging plan to let the sun shine in on safety issues, plant inspections and the agency's specific reasons for rejecting a new drug application.

BIO has yet to respond to the set of 21 proposals assembled by an FDA task force headed by FDA Principal Deputy Commissioner Joshua Sharfstein. Despite some deep-seated reluctance on the part of developers, the movement toward opening up has been gaining steam for years as controversies erupted over the dangers presented by marketed drugs like Vioxx.

Currently, developers have complete discretion to release all or none of the FDA's concerns outlined in its complete response letters, documents that can delay and even kill a new therapeutic. And on more than one occasion developers have been harshly criticized for spinning the contents in their favor. The head of the agency's new drugs office, John Jenkins, said a few months ago that seven out of 10 NDAs lack critical information. Publishing the letters could go a long way to avoiding future pratfalls by developers, Jenkins said. The FDA task force also called for the agency to open up any time a drug application is placed on hold, terminated or withdrawn.

"We should have done this a long time ago," Scott Gottlieb, a fellow at the American Enterprise Institute and FDA deputy commissioner for medical and scientific affairs during the Bush administration. "The public deserves to see the agency's explanations for its decisions."

"Investors are frustrated because very often you have companies that like to spin what is in those complete response letters, and there's no way to know what's really in them," Capitol Street analyst Ipsita Smolinski told Reuters. This way, "there's no question. Everybody has access to the same information."

- here's the story from Bloomberg

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