Dr. Scott Gottlieb Wednesday said he believes the federal government can speed up the approval of new drugs and devices while maintaining standards and leaving decisionmaking in the hands of clinicians.
President Donald Trump's pick for top federal drug and device regulator said faster product approval benefits both patients and physicians. But some of Gottlieb's responses during his confirmation hearing before the Senate Committee on Health, Education, Labor and Pensions alarmed those who say his deep ties to the pharmaceutical industry will cause a conflict of interest.
Gottlieb, a practicing internist in Stamford, Conn., and health industry consultant has for years criticized the FDA regulatory process as too burdensome.
Sen. Elizabeth Warren (D-Mass.) brought up a 2012 Gottlieb penned for the conservative journal National Affairs where he noted a trend in which the FDA has rejected drugs over fears of off-label use.
For instance, a painkiller Arcoxia was rejected in April 2007 because of the concern that it could increase the risk of heart attack and stroke with prolonged use. But the drug was meant for short-term pain relief.
Gottlieb argued in the piece that the FDA did not trust doctors to make those decisions. Warren thought it appeared Gottlieb was against strong consumer protections.
Gottlieb said what he meant to stress was clinician empowerment.
“My concern that the agency was losing confidence in physicians and felt it need to step into, through regulation, into the practice of medicine to try to supplant their judgment for the judgment of doctors,” Gottlieb said.
Adding to concerns over patient protections, Sen. Richard Burr, (R-N.C) asked Gottlieb whether he thought the clinical trial process was burdensome to physicians.
“In 2017, should there still be double blind studies where the doctor doesn't even know if the patient is getting a placebo or not?,” Burr said.
Gottlieb responded the FDA should consider multiple new clinical trial standards to bring innovative products to the market without sacrificing safety and efficacy standards.
“I cannot think of any alternative study design that is superior to a randomized trial in terms of minimizing the chance of selection bias,” said Kay Dickersin, director of the Center for Clinical Trials and Evidence Synthesis at Johns Hopkins Bloomberg School of Public Health.
Dr. Richard Friedman, a clinical trial expert and professor of clinical psychiatry at Weill Cornell Medical College said it was “alarming” to hear Gottlieb's position, adding that “it would put the public at serious potential risk, elevating the financial interests of the drug companies over public health.”
In a conflict of interest notice released by the Trump administration, Gottlieb noted that he had advisory or financial connections to about 30 drug, diagnostic and device companies, including GlaxoSmithKline.
Senate Democrats raised serious concerns about those ties and the fact that Gottlieb has invested in have more than 60 drugs that could come before the FDA for approval in the future. He has also worked for companies that have interest in over 120 drugs that are currently being tested.
Trump has chosen “profoundly conflicted appointees”, according to Norman Eisen, former special counsel to President Barack Obama.
HHS Secretary Tom Price also was criticized during his confirmation process for introducing legislation that would benefit companies he held stocks in when he was a congressman.
Republicans, such as HELP committee chair Sen. Lamar Alexander, noted that Dr. Robert Califf, the final FDA Commissioner under Obama also was friendly with the industry.
Alexander (R-Tenn.) said he believed that history benefits FDA commissioners.
“I'm glad to know that you got a background and experience in the issues before you,” Alexander said to Gottlieb at the hearing.
Gottlieb, 44, was a deputy commissioner of the FDA under President George W. Bush.
He said his first priority will be tackling the opioid epidemic which he said was a serious public health issue on par with infectious diseases like Ebola or Zika. He said solutions will "require dramatic action," including finding ways to spur development of non-addictive alternative painkillers as well as addiction treatments.
A committee vote on Gottlieb's nomination is expected after the Easter recess Alexander said.
The Associated Press contributed to this report.
