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Thread: President Trump nominates Dr. Scott Gottlieb for FDA Commissioner

  1. #1
    Join Date
    May 2007
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    Default President Trump nominates Dr. Scott Gottlieb for FDA Commissioner

    Hooray!! President Trump has nominated Dr. Scott Gottlieb for FDA Commissioner. Let's hope he will be confirmed by Congress. Below is a piece from 2012 that Dr. Gottlieb co-authored. Thanks to member SammyJo for providing the link to it.

    Coleen Klasmeier, Scott Gottlieb
    August 8, 2012 | The Wall Street Journal

    The FDA wants to regulate your cells

    We're on the verge of being able to repair damaged parts with our own tissue. But the research is being stymied in the U.S.

    A recent decision by a federal trial court gave the Food and Drug Administration the latitude that the agency has long sought to regulate our cells as drugs. It could put the brakes on one of the most promising areas of medical research.

    At issue are cells taken from our own bodies and then re-implanted with the purpose of treating medical problems. The most inspiring work involves adult stem cells, although the court’s ruling in principle extends FDA oversight into things as common as in-vitro fertilization—basically turning reproductive cells into “drugs” under the law.

    The adult stem cells can differentiate into many kinds of finished tissues. This enables doctors to use these cells to renew damaged body parts. This science of regenerative medicine has promise across many fields of medicine, from cardiology to brain diseases to orthopedics.

    Obtained from bone marrow in accessible sites like the hip, the adult cells are isolated, grown in a lab, and returned to their donors as part of individualized treatments devised by doctors. Because the cells aren’t products developed on a large scale and sold on the market, they were never subject to FDA’s usual oversight.

    But two weeks ago the United States District Court for the District of Columbia ruled in United States v. Regenerative Sciences LLC that adult stem cells are drugs, even when taken from a person and then re-inserted into the same patient.

    The case involved a group of Colorado physicians who developed a process using adult stem cells to help patients with orthopedic injuries heal faster. The district court accepted uncritically the government’s sweeping position that a cell returned to the same patient in these office-based procedures could be a drug.

    The FDA has repeatedly sought to blur the line between manufacturing medical products and practicing medicine whenever new techniques emerge. But the standard for regulation isn’t whether the agency feels a technique is novel but whether it meets the definition of being a medical product.

    Federal regulators have stretched that definition to the point where a reasonable limit no longer exists. The law provided a clear impediment to unrestrained exercise of FDA authority. Something needed to be an “article”—not a medical procedure—in order to become a drug. The constraint that a drug needed to be a “thing” has been read out of the law by FDA, and the district court appears to have accepted that position.

    If the FDA’s victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency’s reach.

    If human cells processed by the Colorado doctors are “drugs” under federal law, even when these cells are returned to the same patient who donated them, there may be little to prevent the FDA from imposing its drug-approval requirements on any cell-based procedure.

    Doctors will now try to convert procedures into products that can fit FDA’s regulatory rubric. The science will be contorted to fit the regulation, rather than the other way around. Not every cell procedure will lend itself to this sort of revision.

    “Doctors will now try to convert procedures into products that can fit FDA’s regulatory rubric. The science will be contorted to fit the regulation, rather than the other way around. Not every cell procedure will lend itself to this sort of revision.” — Scott Gottlieb, Coleen Klasmeier
    How, for instance, would you run a large-scale, randomized trial and ensure consistency from one use of a drug to another, where the “drug” is really a medical procedure that must vary from one patient to the next because it involves their own unique cells? The FDA requirements, designed for products manufactured and sold on a mass scale, can’t be readily satisfied when it comes to treatments that are personalized to individual patients.

    When the FDA seeks to hold physician procedures to the same rules as pharmaceutical manufacturers, invariably the doctors have no choice but to bow to regulatory pressure, stalling progress. Regenerative Sciences, the defendant in the case, has moved some of its labs to the Cayman Islands. Most of the science of using adult stem cells for regenerative medicine is unfolding in Britain, Singapore and Israel precisely because of the FDA’s bent to hold with misgiving anything novel in medicine.

    The FDA is perennially complaining to Congress that it lacks the resources to do its day job of regulating products that fall squarely in its purview. Yet in chorus, the agency is always seeking novel authority to insert itself into new areas of science where its mandate is shaky.

    This may all be mildly amusing when it comes to the FDA’s efforts to require pre-marketing approval of things like iPhone medical apps—a fight FDA recently won with Congress. But it can be deadly when it comes to the agency’s impulse to regulate, and thus forestall, cell therapies used to help repair damaged body parts.

    Dr. Gottlieb is a resident fellow at the American Enterprise Institute and former Food and Drug Administration deputy commissioner. Ms. Klasmeier is head of the FDA practice at Sidley Austin LLP and previously worked as an attorney at the agency. Both authors work with companies developing cell-based therapies.
    First treatment in 2007. Pioneering ever since.


  2. #2
    Join Date
    May 2007
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    Default Trump has made his FDA pick — here's what that could mean for the agency

    Trump has made his FDA pick — here's what that could mean for the agency

    Lydia Ramsey

    Dr. Scott Gottlieb is Trump's nominee for commissioner of the Food and Drug Administration.

    A White House official confirmed the appointment to Reuters.

    Gottlieb is a resident fellow at the American Enterprise Institute and venture partner at New Enterprise Associates. He previously served as former deputy commissioner of the FDA during George W. Bush's presidency.

    Trump has said that he wants to deregulate the drug industry, which the FDA regulates, and has called the drug-approval process "slow and burdensome."

    "We're going to be cutting regulations at a level that nobody's ever seen before," Trump said in a meeting with drug company executives on January 31. He estimated up to 80% of regulations would be slashed.

    Over the years, Gottlieb has been vocal about his thoughts on the FDA. Here's what his nomination could mean for the future of the agency.

    He says he wants to change up the approval process for "complex generics," devices like the EpiPen or inhalers that competitors have a hard time getting approved. "When it comes to evaluating copies of these complex drugs, the fact is FDA doesn't have very good tools and policies," Gottlieb wrote in a 2014 opinion piece.

    Gottlieb told Stat News that two of his highest priorities would be to ensure the safety of blood supplies and come down on unsafe foods.

    He's also been critical of the pace at which the FDA approves drugs, compared to other countries. In a 2010 opinion piece in The Wall Street Journal, Gottlieb accused the FDA of evading the law.

    Gottlieb emerged early on as a favorite among members of the drug industry. Salim Syed, a biotech analyst at Mizuho, asked pharma executives who they would like to see as the next FDA commissioner. The overwhelming majority (72%) said Gottlieb.

    "I believe Scott Gottlieb is the least likely to rail for the obliteration of the current efficacy, safety, risk-benefit model that is a foundation for advancement of new treatments in the United States," one executive told Syed in the survey.

    What the FDA does
    The FDA is responsible for regulating food and drugs. It's also responsible for regulating medical devices, blood donations, veterinary products, cosmetics, and tobacco. Trump's comments have left the drug industry concerned about what deregulation could mean for the drug-approval process.

    It was officially founded in 1906, when the Food and Drugs Act was signed into law, prohibiting misbranded food, drinks, and drugs from interstate commerce. This cracked down on misleading claims that treatments could "cure" patients.

    Here are some examples of the FDA at work:

    It, of course, approves new drugs. In 2016, 22 new drugs made the cut, compared to 45 the year before.

    In September 2016, the FDA banned antibacterial soap based on evidence that showed that the soaps weren't any better, cleaner, or safer than regular soap.

    The agency cracked down in April 2016 when diet supplements showed up containing a dangerous stimulant.

    The FDA keeps track of any side effects that come up after a drug gets approved, and can make changes accordingly. In July, the agency changed the label on a commonly used class of antibiotics to reflect more potentially permanent side effects.

    It makes sure ads for drugs aren't misleading.
    First treatment in 2007. Pioneering ever since.


  3. #3


    Encouraging that he wrote that price on cells but he is the most pro-regulation of those who were mentioned as candidates.

  4. #4
    Join Date
    May 2007
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    I agree, but he has also been very vocal about streamlining the process for approval. I think he will be confirmed. Far better than what is going on now. Let's hope for the best!

    Trump chooses Gottlieb to run FDA; Pharma breathes sigh of relief

    By Toni Clarke | WASHINGTON

    U.S. President Donald Trump has chosen Dr. Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday.

    If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

    Gottlieb is well known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by drug companies and pharmaceutical investors. He sits on the boards of several small drug and biotech companies and is an adviser to GlaxoSmithKline Plc (GSK.L).

    "Thank God it's Gottlieb," Brian Skorney, an investment analyst at Robert W. Baird, wrote in a research note. "We view this as a favorable development for the sector."

    Gottlieb was chosen over Jim O'Neill, a libertarian investor close to Silicon Valley billionaire Peter Thiel, a PayPal co-founder who now advises Trump on technology and science matters. O'Neill's stated view that drugs should be approved before being proven effective generated widespread alarm.

    Gottlieb, 44, is a resident fellow at the conservative American Enterprise Institute think tank and a partner at a large venture capital fund. He is a former FDA deputy commissioner who has advocated a loosening of requirements needed for approval of new medical products.

    "Scott knows how the agency works and he will move it forwards, though maybe not always in ways the agency is comfortable with," said John Taylor, a lawyer and president of compliance and regulatory affairs with the consulting firm Greenleaf Health and a former acting FDA deputy commissioner.

    In addition to his public health and health policy roles, Gottlieb has for the past decade been a partner at New Enterprise Associates, a large venture fund with investments in the life sciences, medical technology and healthcare services.

    Critics of the nomination say Gottlieb's financial background present an array of potential conflicts of interest.

    Dr. Michael Carome, director of Public Citizen's Health Research Group, said Gottlieb "has spent most of his career dedicated to promoting the financial interests of the pharmaceutical industry." If confirmed, he added, "he will have to be recused from key decisions time and time again."


    Stephen Ubl, a spokesman for the Pharmaceutical Research and Manufacturers of America, said it "looks forward to working with Dr. Gottlieb in his new role and engaging with him and the Agency as they seek to modernize the drug discovery and review process."

    Gottlieb, who declined to comment on the nomination, is unlikely to up-end the FDA in the way O'Neill might have, but he is nonetheless expected to bring significant change, including moving the agency to increase flexibility in the clinical trial development process.

    In this he will be supported by the recently passed 21st Century Cures Act which instructs the FDA among other things to consider the use of "real world evidence" to support new drug applications. This could include anecdotal data, observational studies and patient reports

    "People don't want to take chances with safety, but there's increasingly some clamor to be more flexible on the efficacy side," said Kathleen Sanzo, who leads the FDA practice at the law firm Morgan, Lewis & Bockius. "You need to have some signal of efficacy. The question is, how much?"

    The FDA has attempted to push back against moves to sideline randomized clinical trials, long considered the gold standard. In January it issued a report documenting 22 cases in which drugs that appeared to show promise in early trials turned out to be either ineffective or unsafe or both in larger trials.

    One of Gottlieb's priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.

    "He's a thoughtful and nuanced kind of guy, and not solely an industry shill," said Jim Shehan, head of Lowenstein Sandler's FDA regulatory practice.

    A survey conducted by Mizuho Securities USA Inc of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.

    "Gottlieb is someone who the industry and investors view as an incremental positive," said RBC Capital Markets analyst Michael Yee. "The industry and investors need rational scientific logic and an understanding of risks and benefits."

    Patient advocates welcomed the news.

    Gottlieb "has firsthand experience at the FDA and as a physician that has treated patients understands the breadth of work that needs to be achieved on their behalf," said Ellen Sigal, founder of Friends of Cancer Research.

    (Reporting by Toni Clarke; Additional reporting by Deena Beasley; Editing by Alistair Bell and Lisa Shumaker)
    First treatment in 2007. Pioneering ever since.


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