Gottlieb Becomes FDA Commissioner With Immediate Issues Pending
This article was originally published in The Rose Sheet
Executive Summary
Confirmation comes with fewest votes of any recent commissioner as FDA faces pressing budget, user-fee and other issues. The Personal Care Products Council welcomed Gottlieb to the post and took the occasion to plug cosmetics industry virtues at a time when legislation is under consideration to update regulations.
Scott Gottlieb will begin his tenure as FDA Commissioner with several issues demanding his immediate attention after a sometimes contentious confirmation process.
The Senate voted 57-42 to confirm Gottlieb May 9 in a largely partisan vote. He is the first commissioner the Senate has not confirmed through either a voice vote or unanimous consent, or with fewer than 78 votes in a roll call (see chart below).
The final vote came after Senators voted mostly along partisan lines to end debate on his nomination.
Gottlieb is replacing Acting Commissioner Stephen Ostroff, who has been running the agency since Robert Califf resigned in January. (Also see "Califf Sets Exit At FDA, Ostroff Could Return To Acting Commissioner Post" - HBW Insight, 10 Jan, 2017.)
Scott Gottlieb
Several Republicans praised Gottlieb's qualifications to run the agency, including Senate Majority Leader Mitch McConnell, R-Ky., who said that he looks forward to having a commissioner like Gottlieb who is committed to developing groundbreaking treatments for serious illnesses.
Sen. Lamar Alexander, R-Tenn., chairman of the Senate Health, Education, Labor and Pensions Committee, reiterated that Gottlieb's professional experience is an asset and that he knows first-hand how drugs affect families.
Opposition focused on Gottlieb's preferences for handling the opioid epidemic and potential conflicts of interest, a theme throughout the confirmation process.
Sen. Edward Markey, D-Mass., said the FDA commissioner should understand that "universal health care does not mean that every American should have access to a bottle of prescription opioids."
Sen. Sherrod Brown, D-Ohio, also said that FDA needs a commissioner that will fight the epidemic, not one who will "roll over for his big pharma friends."
Gottlieb has called the opioid epidemic a public health emergency that should demand a response akin to that of the Ebola and Zika outbreaks.
HELP Committee Ranking Member Patty Murray, D-Wash., also said she still has questions about Gottlieb's stances on FDA policy and remains concerned whether Gottlieb could ensure independent and science-based agency decisions.
Source: Senate voting records
Gottlieb's career working at a venture capital firm and investment bank has raised questions about conflicts of interest. (Also see "Gottlieb Recognizes OTC Monograph Woes During Confirmation Hearing" - HBW Insight, 6 Apr, 2017.)
The Personal Care Products Council issued a statement May 9 congratulating the new commissioner, who is "well-qualified for the position" with a strong reputation for protecting public health, the trade group says.
PCPC also took the occasion to plug cosmetics industry virtues at a time when legislation is under consideration to update regulations, emphasizing the sector's safety record and continuing focus.
"Consumer and product safety are top priorities for the cosmetics and personal care products industry, with careful and thorough scientific research and development serving as the foundation for everything we do," the group states.
Highlighting the industry's near-$3bn annual investment in scientific research and development, which yields around 2,000 new products each year, PCPC adds, "We look forward to working with [Gottlieb] to ensure that well-crafted, science-based regulations enhance our industry’s ability to innovate and further strengthen consumer confidence in the products they trust and enjoy every day."
Budget, User Fees Already Moving Forward
FDA's budget likely will be one of the pressing issues that Gottlieb will have to deal with upon taking office at the agency's White Oak headquarters.
While a fiscal year 2017 spending plan is in place, the agency will have to negotiate a budget for FY 2018 in a potentially difficult congressional environment.
FDA received an increase in non-user fee funding in the FY 2017 omnibus appropriations legislation signed in late April. Much of the increase was outside the drug centers, mainly because of an expected reduction in user fee revenue. (Also see "FDA Gains Budget Increase In FY 2017 … And Not Through Fees" - HBW Insight, 2 May, 2017.)
But in FY 2018, the White House has called for substantial cuts in budget authority for the agency that would be made up by user-fee revenue increases, although that seems unlikely. (Also see "Trump's Budget Blueprint: Cosmetics Opportunity Or Unhelpful Distraction?" - HBW Insight, 22 Mar, 2017.)
The formal White House budget request, expected in the coming weeks, will include more detail, but Gottlieb likely will be called upon to advocate for agency resources.
Also making its way through Congress is reauthorization legislation for FDA's prescription drug, generic drug, medical device and biosimilar user-fee programs. The HELP Committee is scheduled to mark-up its version of the bill on May 11.
Gottlieb will be among those providing technical assistance to members of Congress as they complete the legislation and may have to give opinions on the feasibility of implementing add-ons that undoubtedly will be attached to the bill.
So far there are only a few of those, but traditionally the user fee bill – considered must-pass – attracts numerous FDA policy and related riders. The cosmetics industry started the year on a mission to yoke cosmetics regulatory reform provisions to user-fee legislation, but has since indicated that it likely isn't in the cards. (Also see "Cosmetics Provisions Unlikely To Catch Ride On FDA User-Fee Bill" - HBW Insight, 27 Apr, 2017.)
FDA also continues to work on various guidances for industry, but has released only a few since the Trump Administration took office. Gottlieb, upon his entrance, will have to set his policy direction and review and approve those that are pending. (Also see "Ostroff: Administration Coming Up To Speed On Planned FDA Guidances" - Pink Sheet, 4 May, 2017.)
A Short Wait Despite Low Senate Vote Total
Gottieb's low Senate vote total could mean he has less Capitol Hill support, and therefore less margin for error.
His predecessor, Califf, received 89 votes in the Senate, which he suggested gave him the leverage to potentially keep the job after the presidential election, if he had wanted to stay. (Also see "Califf Maintains Desire To Stay At FDA, But Would Either Presidential Candidate Keep Him?" - Pink Sheet, 5 Nov, 2016.)
But Gottlieb also enjoyed the shortest time waiting to take office in more than a decade. He waited less than two months from nomination to confirmation, unlike Califf, who waited more than five months, and Margaret Hamburg, who waited slightly longer than two months (see charts below).
It marks the shortest spell for FDA between commissioner resignation and replacement confirmation since 1990, signaling the Senate's recognition that despite the concerns raised, the agency operates better with a confirmed leader.
The time between Califf and Gottlieb will be about 3.6 months, compared to the time between Hamburg and Califf, which was nearly 11 months, and the time between Andrew von Eschenbach and Hamburg, which was about 3.9 months.
Gottlieb's confirmation process has largely followed the swift pathway sometimes seen for commissioner nominations that are made shortly after a new president takes office. (Also see "FDA's Next Commissioner: Will Trump Follow Hamburg Or McClellan 'Schedule'?" - Pink Sheet, 30 Jan, 2017.)
Source: FDA information and Pink Sheet archives