FDA Talking To Industry About Releasing “Complete Response” Letters
This article was originally published in The Pink Sheet Daily
Executive Summary
Commissioner Hamburg says conversations are underway with industry to allow the agency to release its reasons for not approving a product, in part so others will not waste funds repeating known failures. FDA is also working to remove user fee revenue from sequestration.
FDA Commissioner Margaret Hamburg is working with industry to find a way for it to make “complete response” letters public.
Aside from shining a light on application problems and failures, which have been tightly held sponsor secrets, the move also could be couched as a money-saving feature for government and industry at a time when dollars are scarce.
The issue emerged Feb. 6 during a congressional briefing on the research and drug development enterprise, sponsored by Faster Cures and the Friends of Cancer Research.
The discussion quickly moved to the across-the-board budget cuts known as sequestration and how FDA, the National Institutes of Health and other federal agencies should avoid the now estimated 5% to 6% reduction.
Hamburg, NIH Director Francis Collins and others spent more than an hour talking about the importance of their agencies to the bioscience industry and how continued funding is important to the U.S. economy.
During the discussion, Hamburg responded to a question about non-revenue-related authority that could help by mentioning that FDA, industry and others should be able to learn from each other’s experiences, including the reasons FDA does not approve a product.
“You might give up a little bit of your own proprietary information but you’ll benefit from the ability to share information from others as well,” she said. “It’s a fairly small step, but I think it could open up a lot of opportunity and prevent work that will fail.”
FDA is talking about the idea internally, as well as with partners on an informal basis, Hamburg said after the hearing. She said the sponsor would have to sign off before a “complete response” letter is released.
FDA now is forbidden from releasing the information.
Recently, the agency released a statement and question-and-answer document explaining issues related to its rejection of Hemispherx Biopharma Inc.’s Ampligen (rintatolimod) (Also see "Hemispherx Vows To Fight FDA’s Second Rejection Of Ampligen" - Pink Sheet, 5 Feb, 2013.).
The idea is part of a broader agency transparency initiative. FDA officials already have indicated a willingness to release more information about their internal workings with sponsors.
Office of New Drugs Director John Jenkins has said he would like to release minutes of sponsor formal meetings or teleconferences so there is more than one interpretation of the discussions available to the public. FDA now is not allowed to respond when sponsors release information about the meetings (Also see "“Emerging Sponsors” Pose Regulatory, Public Relations Challenges For Drug Review Process, FDA’s Jenkins Says" - Pink Sheet, 8 Dec, 2011.).
FDA Wants To Avoid Losing User Fees To Sequester
FDA also is pushing to avoid subjecting user fees to the sequester.
The pending cuts are expected to hurt the agency’s ability to implement new and expand existing programs, such as those for generic drugs and biosimilars, and slow hiring of scientific and other personnel.
An Office of Management and Budget estimate released in September indicated user fee revenue, which includes charges for new drug applications and other submissions, would be eligible for the cut along with the agency funding from the Treasury.
OMB said there was no legal basis for exempting user fees from sequestration (Also see "FDA’s 8.2% Solution: Sequestration Would Cut $319 Million" - Pink Sheet, 14 Sep, 2012.).
The cuts were scheduled to go into effect in January, but Congress approved a delay until March 1, which also reduced the amount that would be cut.
A Congressional Budget Office budget outlook released Feb. 5 indicates non-defense discretionary spending would be cut 5.3% if the sequester is implemented.
Hamburg said during the Feb. 6 briefing that Congress should give more consideration to the effect that sequestration, as well as including user fee dollars, would have on FDA.
“Industry was willing to put up money to support performance in critical areas,” she said. “Those user fee dollars are actually at risk … which I think many people don’t understand and it’s something to think seriously about.”
The briefing was the second consecutive day Hamburg publically advocated against the sequestration cuts.
On Feb. 5, Hamburg said the cuts could force FDA to conduct about 2,100 fewer inspections of domestic and foreign food facilities. Her remarks came shortly after President Obama asked Congress to pass a short-term sequester delay (Also see "Hamburg Details Some Sequestration Impact On FDA" - Pink Sheet, 5 Feb, 2013.).