Gottlieb: FDA Doesn’t Have To Choose Between Speed And Safety
Dr. Scott Gottlieb, President Donald Trump's pick to head the Food and Drug Administration, answered questions about drug safety, the opioid epidemic, his potential conflicts of interests and more at his Senate Health, Education, Labor and Pensions Committee confirmation hearing.
The New York Times:
F.D.A. Nominee Deflects Criticism About Ties To Drugmakers At Hearing
Dr. Scott Gottlieb, President Trump’s nominee to lead the Food and Drug Administration, told Congress on Wednesday that he could speed the approval of new drugs without compromising safety or increasing risks, deflecting questions about his past writings, drug-company investments and Mr. Trump’s controversial positions. “We should reject a false dichotomy that it all boils down to a choice between speed and safety,” Dr. Gottlieb said at his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee. (Pear, 4/5)
Stat:
Scott Gottlieb Says FDA Must Strike Right Balance On Risk, Regulation
The 44-year-old doctor, investor, and conservative policy wonk, nominated to run the Food and Drug Administration, appeared before a Senate panel for a confirmation hearing, telling lawmakers that he would be an “impartial and passionate advocate for public health.” “We need to make sure we’re getting the most bang for our regulatory buck,” Gottlieb said in his opening statement. “That means being cognizant of risks and being sure that we’re not adding to consumer costs without improving consumer safety.” (Kaplan, 4/5)
The Wall Street Journal:
FDA Nominee Scott Gottlieb Commits To ‘Gold Standard’
Dr. Gottlieb, who was nominated in March, said he sees the need for new laws and FDA regulatory action to get complex-formulation drugs—like those used topically or with inhalers—more quickly approved as lower-cost generics. While he also said there are ways to speed up some clinical trials, “I think there are ways to modernize clinical studies without sacrificing the gold standard.” (Burton, 4/5)
The Washington Post:
FDA Nominee Says Nation’s Opioid Crisis Is As Serious As Ebola, Zika Threats
During his confirmation hearing before the Health, Education, Labor and Pensions Committee, Gottlieb described the FDA as “complicit, even if unwittingly,” in helping to fuel the opioid epidemic. Officials, he said, “didn't fully recognize the scope of the emerging problem” several years ago and needed a new strategy to combat the issues involved. (McGinley, 4/5)
The Associated Press:
Trump's FDA Pick Says Tackling Opioid Crisis A Top Priority
Gottlieb said opioid addiction is "the biggest crisis facing the agency" and as serious a public health challenge — for the entire government, not just FDA — as infectious diseases like Ebola or Zika. He said tackling the crisis would be his first priority and will "require dramatic action," including finding ways to spur development of non-addictive alternative painkillers as well as addiction treatments. (Neergaard, 4/5)
Morning Consult:
Gottlieb Calls Opioid Epidemic ‘Biggest Crisis’ Facing FDA
“The opioid epidemic in this country is having staggering human consequences,” Gottlieb said. “I think this is the biggest crisis facing the agency and is going to require dramatic action on the part of whoever steps into the agency.” The issue was a focal point during the hearing, with several lawmakers raising concerns about the role of the FDA, which regulates opioid medication, in responding to the crisis. (McIntire, 4/5)
The Hill:
Senators Battle Over FDA Nominee's Financial Ties
President Trump’s nominee to lead the Food and Drug Administration faced repeated questions Wednesday over possible conflicts of interest related to his financial ties to an industry he would be tasked with regulating. Democrats on the Senate Health, Education, Labor and Pensions Committee peppered Scott Gottlieb with questions about whether he would be unable to separate himself from the interests of more than two-dozen drug and medical device companies he’s either invested in or consulted for. (Wheeler, 4/5)
The CT Mirror:
FDA Nominee Gottlieb Says He’d Challenge Trump On Vaccines
Gottlieb also said he would not be influenced by any sector of the health care industry, despite his job at New Enterprise Associates, a large venture capital firm that is heavily invested in medical technology and healthcare companies. “I want to earn and keep the public’s trust,” Gottlieb told the Senate Health, Education, Labor and Pensions committee. (Radelat, 4/5)
Modern Healthcare:
Gottlieb Favors Regulations That Empower Doctors While Keeping FDA Standards
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. (Dickson, 4/5)
Bloomberg:
Opioid Epidemic Is FDA's Top Priority, Says Pick To Head Agency
Gottlieb is likely to be confirmed by the full Senate when he eventually gets a vote. His comments to the committee Wednesday seemed to assuage concerns by some senators on the drug crisis as well as other issues, including potential conflicts of interest that come from his work as a consultant and investor. (Edney, 4/5)
Politico Pro:
Gottlieb Wants To Prevent Drug Makers From Gaming FDA
FDA commissioner nominee Scott Gottlieb said he wants to craft policies to prevent drug companies from abusing the FDA approval process to prevent competition, leading to higher drug prices. "We should try to design policies that prevent those abuses because we don't want to be playing whack-a-mole with companies and going after them one-by-one," Gottlieb told Sen. Tammy Baldwin during a Senate HELP Committee hearing on his nomination. (Karlin-Smith, 4/5)
The Wall Street Journal:
FDA Nominee Not All Good News For Drug Makers
An industry-friendly commissioner seems to be coming to the Food and Drug Administration. While he is favored by many executives, not all drug makers will be happy once he gets on the job. Such is the takeaway from Scott Gottlieb’s confirmation hearing to take the helm of the agency Wednesday. (Grant, 4/5)
