Gottlieb Criticized on Industry Ties at Nomination Hearing
Faced with harsh criticism from Democrats about his ties to regulated industry, FDA commissioner nominee Scott Gottlieb told members of the Senate Health, Labor, Pensions & Pensions 4/5 that his work with industry and investing in medical technology projects have taught him “the need for an absolutely objective regulatory watchdog over this field. If confirmed, I’ll lead the FDA as an impartial and passionate advocate for public health.” As a cancer survivor, Gottlieb said he knows what is at stake: “People’s lives are literally on the line when it comes to the decisions FDA makes, its oversight, and its enforcement of Congress’s laws.”
Committee chairman Lamar Alexander (R-TN) said Gottlieb has “impressive qualifications from nearly every perspective” and is the right person to lead FDA and its “vital mission” for patients. As for his previous work with companies regulated by FDA, such ties are not so unusual for someone who is going to be head of FDA, he said. “In my view, it helps to have somebody who knows something about the subject,” he added. His predecessor, Robert Califf, who also supports Gottlieb’s nomination, was previously employed by over 20 drug and device companies before he became commissioner, and cleared the Senate with a 95 to 4 vote, he reminded committee members.
Asked by Alexander about how he will handle the Trump Administration’s hiring freeze that could impact the implementation of the 21st Century Cures Act, Gottlieb said he understands the importance of a strong workforce in order to maintain FDA’s regulatory gold standard. As in the past when he served as FDA deputy commissioner, he said he will continue to be very vocal about the importance of FDA’s staff and resources in order to fulfill its public health mission.
Committee ranking member Patty Murray (D-WA) expressed her disappointment with the limited time members were given to review committee paperwork regarding Gottlieb’s “unprecedented financial entanglements with regulated industry” and over 800 published articles. Murray told Gottlieb that she has growing concerns about whether he can withstand political pressure “pushing you to ignore science” and uphold the gold standard and “lead FDA in an unbiased way given his unprecedented industry ties.” Specifically, in her opening testimony she said she was bothered by his previous role at the agency and his defense of the Bush Administration’s delay in granting over-the-counter sales of the Plan B emergency contraceptive (see earlier story), which she characterized as “allowing politics to interfere with science.”
Murray acknowledged Gottlieb’s intention to divest and recuse himself from matters that present a conflict, but she said she was still concerned about his previous roles of investing in and advising companies under FDA jurisdiction and then using his article writing and “public platform to promote policies that could benefit these companies.” She said she was bothered by his position on off-label communication, as shown in 2006 when he wrote that FDA restrictions could slow important advances in 21st century medicines. “I would argue that we have seen incredible advances in medicine, while also ensuring only truthful and non-misleading information is given to doctors and patients.” She said she also has concerns about his position describing FDA “regulatory overreach,” including opposition to regulating medical apps and risk evaluation and mitigation strategies known as REMS that are meant to protect patients. In response, Gottlieb said he recognizes the importance of maintaining his impartiality as FDA commissioner, if confirmed, and he will work with the government’s ethics personnel to comply with the laws.
Noting that president Trump has called FDA slow and burdensome, Murray asked Gottlieb if he will commit to making decisions on safety and efficacy based on standards in the current law and on the science and not bow to political pressure from the administration. “I am going to be guided by the science and the expertise of the career staff, and I am going to be guided by impartiality and what is good for patients as a physician,” he said. Prodded further to commit to standing up to the administration if it puts political pressure on him, Gottleib said has never been shy about “offering my unvarnished advice... I am going to continue to offer people my clear thoughts on issues I am asked to opine on, including my bosses.”
Asked by Sen. Richard Burr (R-NC) whether it is necessary to conduct double blind studies where doctors don’t know if the patient gets a placebo or active drug, Gottlieb said he believes there are opportunities to modernize clinical trials in ways that are not going to sacrifice the gold standard of safety and effectiveness. He said Congress has directed the agency under the Cures Act to look at alternative clinical trial designs as part of the review process. “I believe getting efficient implementation of Cures and following Congressional intent in that regard is going to be an essential part of what I hope to do if I am confirmed into this role.”
Responding to a Burr question about employee recruiting and retention, Gottlieb said employee expertise and institutional knowledge is one of the critical issues facing the agency because of the complexity of the science coming before the agency. This will require more specialized talent, he said, adding that he is also was worried about FDA’s aging workforce and the impact of upcoming retirements.
In closing the hearing, Alexander noted that most of criticism of Gottlieb has been associated with the ties he has had with industry. He repeated his support and welcomed Gottleib’s broad experience as an asset for the agency if confirmed because he will recognize when a company may be “gaming the system.” Alexander said it will be at least two weeks before the committee will vote, to allow members to thoroughly consider Gottlieb and his record.