FDA Program Cuts Loom If ‘Cures’ Bill Isn’t Fully Funded, Ostroff Warns
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA’s acting commissioner says agency may have to ‘stop doing something else’ in order to cover the new responsibilities envisioned in the Cures legislation.
Acting FDA Commissioner Stephen Ostroff remains optimistic that the House and Senate will fill the funding gap in the 21st Century Cures legislation and not force cuts to other programs.
The bill, intended to help get innovative medical products to patients faster, has cleared the Energy & Commerce Committee and House sponsors are anxious to get it to President Obama by the end of the year.
The legislation contains a number drug-related and other mandates that FDA thinks could cost more than $900 million to implement. Energy and Commerce Committee members included some additional agency funding, but it is not enough to meet the estimate.
Ostroff told the Alliance for a Stronger FDA June 3 that any unfunded mandates in the bill may require resources to be shifted from other activities.
“If there are things that are included in 21st Century that are not funded, that would be a significant issue and a significant problem for us because there are only a couple of additional ways that we could make up for those shortfalls,” he said.
“Unfortunately, if we have to stop doing something else … I think we would lose some of the momentum and some of the progress in those areas.”
The warning is a stronger statement about FDA’s budget than Ostroff made in an earlier public appearance shortly after taking over for Margaret Hamburg.
Ostroff told the Food and Drug Law Institute in April that the agency is better resourced now than ever, but still needs to keep up with scientific advances (Also see "FDA Staying The Course Under Ostroff; Hamburg’s Concerns Will Remain Focus" - Pink Sheet, 20 Apr, 2015.).
Overall, the Cures bill largely has been praised by numerous patient groups and industry, but it also is finding critics beyond its lack of FDA funding.
Jerry Avorn and Aaron Kesselheim, both of Harvard Medical School, published an perspective piece in the New England Journal of Medicine online June 3 stating that the Cures bill “could actually bring back some of the problems we thought we had left behind in the 20th century.” They also said the bill could lead to the approval of drugs “that are less safe or effective than existing criteria would permit.”
The Senate also has its own Cures-like effort underway moving at a much slower pace, which may add more mandates to FDA’s plate (Also see "Senator Tells FDA To Create ‘Red Team’ For Regulatory Streamlining" - Pink Sheet, 28 Apr, 2015.).
Some Money Better Than None, Ostroff Says
Ostroff did not indicate FDA is thinking about potential cuts should the Cures bill pass as is.
He said there still is a long way to go before the final bill is sent to the White House, meaning there is time to work out ways to find the necessary dollars.
The Cures legislation already includes $550 million in additional money over five years through sales of oil from the U.S. Strategic Petroleum Reserve. An additional $90 million in appropriations also would be authorized (Also see "21st Century Cures Now A Partially Funded Mandate For FDA" - Pink Sheet, 21 May, 2015.).
The oil money was considered a deficit-neutrality measure (Also see "FDA Funding Gets Boost In Cures Bill, But Is Industry Pleased?" - Pink Sheet, 25 May, 2015.).
Ostroff still was pleased House members were able to add some funding to the draft.
“From my perspective, half a loaf is better than none,” he said.
After the presentation, Ostroff said that he thought Congress understood that FDA will not stop executing the new mandates once the five-year funding commitment expires, indicating a long-term funding solution also will be necessary.
Agency officials estimated provisions to enhance biomarker qualifications would cost as much as $188 million. Cures’ expansion of the Sentinel program was estimated to cost about $100 million over five years (Also see "Biomarker Qualification Costs As Much As Application Review, FDA Says" - Pink Sheet, 20 May, 2015.).
Extra Money Found In User Fee Talks?
One alternative to diverting resources would be to add the issues to user fee reauthorization talks where appropriate, Ostroff said.
Negotiations are scheduled to begin in the coming weeks, but industry may not be too excited about increasing fee payments to support congressional ambitions.
Prescription drug user fee negotiations are set to open after a July 15 public meeting (Also see "User Fee Renewal: Shape Of PDUFA VI Depends On Effectiveness Of ‘Program’" - Pink Sheet, 13 May, 2015.).
FDA and the Alliance also face an uphill battle gaining more direct funding from Congress. House Appropriations Committee members already have indicated that the upcoming agency budget likely will be flat (Also see "Next FDA Commissioner May See Funding Freeze" - Pink Sheet, 4 Mar, 2015.).