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April 6, 2017

5 key issues Trump's FDA pick discussed during his confirmation hearing

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    Scott Gottlieb during his Senate confirmation hearing Wednesday touted his plans to rein in increasing drug prices, defended his ties to the industry, and sought to put an end to ongoing debate about vaccines and their link to autism.

    Gottlieb, a physician, has spent much of his career working the pharmaceutical and health care industries, which some experts say presents the possibility for several conflicts of interest. In financial disclosure documents released last week, Gottlieb said he would recuse himself for one year from agency decisions regarding more than 20 companies he has been tied to financially.

    The Senate Health, Education, Labor, and Pensions (HELP) Committee will vote on whether to move Gottlieb's nomination to the Senate floor after the Senate returns in late April from a two-week recess.

    Gottlieb in his opening statement said, if confirmed, he would "lead the FDA as an impartial and passionate advocate for public health." He added, "I'll be guided by the scientific rigor that the public deserves."

    During the hearing he touched on five key issues.

    Curbing the opioid misuse epidemic

    Gottlieb told lawmakers on the Senate HELP panel that addressing the nation's opioid misuse epidemic would be his top priority. "I think this is a public health emergency on the order of Ebola and Zika" that will "require dramatic action," Gottlieb said. 

    He said that FDA was "complicit, even if unwittingly," in helping to fuel the opioid epidemic and that new strategies must be developed to increase access to non-addictive alternative painkillers and new treatments for opioid use disorders.

    Empowering providers while maintaining safety and efficiency

    During the hearing, Gottlieb also faced questions about a 2012 article he wrote in National Affairs in which he argued that FDA's inclination to reject drugs for off-label purposes suggested the agency did not trust providers to make those clinical decisions. Gottlieb said his article was meant to stress clinician empowerment. "My concern (was) 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," he said.

    Sen. Richard Burr, (R-N.C) also questioned the current "gold standard" of double-blinded studies for clinical trials and asked whether he believes the process is burdensome to physicians. Burr asked, "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?"

    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 think there are ways to modernize clinical studies without sacrificing the gold standard of safety and effectiveness," he said, adding, "Perhaps there are ways to think of clinical trial constructs that don't require the tight randomization that current clinical trials do."

    Further, Gottlieb noted that in the past he has suggested combining phase II and phase III clinical trials "into one big adaptive design."

    Reducing drug prices

    Gottlieb during the hearing also said FDA should take regulatory action to more quickly improve lower-cost generics for complex formulation drugs, such as those used topically or with inhalers.

    When asked by Sen. Rand Paul (R-Ky.) about ways the agency could increase competition among generic products, Gottlieb identified two problems. First, it can take up to four years to get a product approved, which he called "a solvable problem and something [he'd] like to work on." The second problem, which he said is "more complex, is that the agency doesn't have good standards for substantial equivalence" of complex formulation drugs.

    Sen. Bernie Sanders (I-Vt.) also raised concern about what the agency could do to bring down the high cost of drugs, noting that President Trump campaigned on importing lower-cost drugs from Canada and allowing Medicare to negotiate drug prices—and Gottlieb in a Forbes opinion piece had pushed back on Trump's arguments on drug importation.

    Trump, pharma execs discuss possible industry changes

    Gottlieb said, "I can't speak to why the president nominated me for this role, but I have a lot of ideas ... for how I think we can get more product competition onto the market" to bring down drug prices.

    Acknowledging the safety of vaccines

    During the hearing, Gottlieb received questions on issues of vaccine safety. He said science has proven that vaccines do not cause autism, and that policy should move forward based on that data.

    "This is one of the most exhaustively studied questions in scientific history," Gottlieb said. "I think we need to come to the point where we can accept 'No' for an answer, and come to the conclusion that there is no causal link between vaccinations and autism."

    Addressing financial ties to the industry

    Senate Democrats during the hearing raised concerns about Gottlieb's ties to the drug industry.

    According to Modern Healthcare, Gottlieb has invested in more than 60 drugs that could come before the FDA for approval in the future and has worked for companies that have interest in more than 120 drugs currently being tested.

    When pressed on those connections—including his involvement in New Enterprise Associates, which invests in startup companies in the biopharmaceutical, health care services, and medical device industries—Gottlieb said he is proud of his work. But he added, "I recognize the importance of bringing impartiality to this position. ... I am going to be cognizant of trying to make sure to preserve the integrity of my role and do nothing in exercising my obligations ... that will besmirch the agency. I get it; I know why people care. The FDA's decisions are literally matters of life and death."

    Committee chair Sen. Lamar Alexander (R-Tenn.) said he is "glad" that Gottlieb has "background and experience in the issues" that would be before him, if confirmed. He also noted that Gottlieb had already met with the Office of Government Ethics "which carefully reviewed [his] financial information and found that, with several recusals which [Gottlieb has] committed to do, [he is] 'in compliance with applicable laws and regulations governing conflicts of interest'" (Frieden, MedPage Today, 4/5; Dickson, Modern Healthcare, 4/5; Burton, Wall Street Journal, 4/5; McGinley, "To Your Health," Washington Post, 4/5; Neergaard, AP/Sacramento Bee, 4/5).

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