Thursday, December 03, 2009

Ending Secret Letters on Drug Delays May Speed U.S. Reviews

Secret communications between drugmakers and U.S. regulators about product delays may become public record, a move one health official says would prevent his staff from wasting time on incomplete applications.

It’s “a real failure” on industry’s part that 70 percent of medicines submitted to the Food and Drug Administration lack information needed for approval, John Jenkins, head of the agency’s Office of New Drugs, told industry representatives today at a conference in Washington. The FDA’s transparency task force is considering publishing the so-called complete response letters sent to companies outlining the outstanding issues.

Drugmakers pay to the FDA in exchange for the agency’s pledge to approve complete applications within 10 months, and extending reviews “puts an incredible burden on the system,” Jenkins said. While delays are now usually blamed on staffing or budget shortfalls at the FDA, companies may act differently if investors knew they hurry submissions, he said.

“I’ve argued for years and years that we’ve held up our end of the bargain,” Jenkins said at sponsored by London- based, publisher of the Pink Sheet for the pharmaceutical industry. “If the complete response letters were released publicly, would you wait to submit your application when you were more ready so you would get a first-cycle approval?

“Think of all the work we can do on other projects if my staff wasn’t spending all their time on resubmissions,” he added.

Six-Month Effort
The task force led by, the FDA’s principal deputy commissioner, was formed in June in response to the Obama administration’s call for greater transparency among federal agencies. The group of FDA officials planned to submit a report to Commissioner after a six-month review that included two public meetings.
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