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posted by chromas on Friday June 28 2019, @10:01AM   Printer-friendly
from the welcome-back dept.

Scott Gottlieb walks through the revolving door to the Pfizer board

The revolving door turns again. After a two-year stint running the Food and Drug Administration, Scott Gottlieb has joined the board of directors at Pfizer, giving the world's largest drug maker crucial insights into the inner workings of the Trump administration as it attempts to contain national angst over the rising cost of medicines.

And in doing so, Gottlieb is also picking up where he left before joining the agency, since he had been on the board of several smaller pharmaceutical companies and was also a partner at a venture capital firm that invests in life sciences companies.

"This is classic and it's not surprising," said Sidney Wolfe, a founder of Public Citizen Health Research Group and a long-time FDA watchdog, who had expressed concern about Gottlieb's ties to industry before joining the agency. "Philosophically, he's returning to the ecosystem where he's most comfortable. And he'll get paid very well for it, too."

Also at Financial Times.

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Drug Approvals Sped Up in 2017
Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation
FDA Labels Kratom an Opioid
FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] (including Pfizer)
U.S. to Make More Drugs Easily Available, Cutting Role Docs Play


Original Submission

Related Stories

What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry 33 comments

President Trump will likely nominate Dr. Scott Gottlieb as head of the FDA. Though he is presently a resident fellow at the conservative American Enterprise Institute and a partner at a large venture capital fund, he used to be an FDA deputy commissioner known for advocating dramatic reforms in the process to approve new medical products.

According to his statements as well as comments to people familiar with his thinking on the FDA, Gottlieb intends to shoot for the rapid approval of complex generics, ushering in a wave of less expensive rivals to some of the biggest blockbusters on the market. He's also likely to spur the FDA to follow the course laid out by agency cancer czar Richard Pazdur in speeding new approvals, possibly setting up a special unit aimed at orphan drugs to hasten OKs with smaller, better designed clinical trials. Other potential reforms include the possible quick adoption of new devices that could be used to improve the kind of medtech Apple, Verily and others have been working on.

Gottlieb is viewed very favorably within the pharmaceutical industry as a regulatory reformer but not destroyer. If nominated, he will have been chosen over another high-profile name on the short list: Jim O'Neill.

The close associate of Peter Thiel, O'Neill famously suggested that drugs should be approved based on safety alone, letting consumers sort out what works. That left many fearing that Trump intended to toss out the regulatory framework for new drug approvals, raising fears that his idea of competition would allow de facto placebos to compete for market share.


Original Submission

FDA Nominee is a Proponent of "Adaptive Trials" 21 comments

Scott Gottlieb, President Trump's nominee to run the FDA, is a proponent of adaptive clinical trials, which would allow adjustments of trials as they are ongoing:

In 2006, Scott Gottlieb, then a deputy commissioner at the U.S. Food and Drug Administration (FDA), stood before an audience of clinicians and researchers to sing the praises of a new approach to drug trials. Instead of locking in a study's design from the start, researchers could build in options that would allow them to adjust along the way, based on the data they had collected. They could make the trial larger or smaller, for instance, add or remove arms, or change how incoming patients get assigned to them. Gottlieb predicted such adaptive trial designs, the topic of the conference he attended that distant summer in Washington, D.C., would "tell us more about safety and benefits of drugs, in potentially shorter time frames."

This week, as President Donald Trump's nominee to head FDA, Gottlieb sat before Republican lawmakers hungry for promises of "shorter time frames" for drug and device approvals, and again expressed his zeal—repeatedly—for adaptive trial designs. If confirmed to be FDA's head, as expected, Gottlieb suggested he'd promote wider use of the approach.

But for all their promise, many adaptive trial features still aren't commonplace. And Gottlieb will face a number of obstacles to encouraging their wider use, experts tell ScienceInsider.


Original Submission

Drug Approvals Sped Up in 2017 4 comments

New drug approvals hit 21-year high in 2017

U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union.

The EU recommended 92 new drugs including generics, up from 81, and China laid out plans to speed up approvals in what is now the world's second biggest market behind the United States.

Yet the world's biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies. Consultancy Deloitte said last month that projected returns at 12 of the world's top drugmakers were at an eight-year low of only 3.2 percent.

Many of the drugs receiving a green light in 2017 were for rare diseases and sub-types of cancer, which often target very small populations, although they can cost hundreds of thousands of dollars. Significantly, the U.S. drug tally of 46 does not include the first of a new wave of cell and gene therapies from Novartis, Gilead Sciences and Spark Therapeutics that were approved in 2017 under a separate category.

Food and Drug Administration Commissioner Scott Gottlieb has indicated that it might be time to revise the Orphan Drug Act of 1983.


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Politics: Koch-Backed Groups Urge Congress to Pass "Right to Try" Legislation 56 comments

Groups funded by Charles and David Koch have launched ad campaigns aimed at urging Congress to pass legislation that would make it easier for terminally ill patients to try experimental treatments. The bill passed the Senate unanimously, but FDA Commissioner Scott Gottlieb told the House in October (archive) that the FDA already approves 99% of requests for expanded access/compassionate use, and that the primary roadblock is not the FDA, but drug supply constraints. He said that pharmaceutical companies do not continuously manufacture a drug undergoing clinical trials, but instead produce "discontinuous batches":

Several deep-pocketed political advocacy groups founded by Charles and David Koch are ramping up their advocacy before Congress on a niche issue: access to experimental drugs.

On Monday, several Koch-backed groups, including Freedom Partners and Americans for Prosperity, launched an ad campaign urging Congress to pass so-called "right-to-try" legislation, which aims to help terminally ill patients access experimental treatments that haven't yet been approved by the Food and Drug Administration. The Senate unanimously passed a right-to-try bill from Sen. Ron Johnson (R-Wis.) last August, but it has since stalled in the House. Supporters, including lawmakers on Capitol Hill and other off-the-Hill advocates, are focusing their efforts this month on the Energy and Commerce Committee, which would likely have to clear the legislation before the full House could vote on it.

The new ad campaign — also sponsored by Generation Opportunity and The LIBRE Initiative — directly addresses Congress, saying at the end of one commercial, "Congress, give patients a chance. Pass right to try." In addition to a series of digital ads focused on D.C. and key congressional districts, the campaign will include lobbying efforts by the groups, according to a press release. In a letter sent Monday to Committee Chairman Greg Walden (R-Ore.), executives wrote, "We strongly urge your committee to act expeditiously to approve Right to Try legislation and send the bill to the House Floor for a full vote."

Johnson told STAT he's doing everything he can this month to get the legislation passed, and suggested the vice president might become even more engaged. Vice President Mike Pence has supported right-to-try efforts since he signed a similar law as governor of Indiana.

S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017

Related: What a Gottlieb-Led FDA Might Mean for the Pharmaceutical Industry
FDA Nominee is a Proponent of "Adaptive Trials"
Texas Sanctions FDA-Unapproved Stem Cell Therapies
University Could Lose Millions From "Unethical" Research Backed by Peter Thiel
"Black Hole" of Accountability for Drug Trials Flouting FDA Oversight?
Drug Approvals Sped Up in 2017


Original Submission

FDA Labels Kratom an Opioid 37 comments

FDA Commissioner Scott Gottlieb has released a new statement denouncing the drug kratom. The statement says that the FDA has learned about new deaths that "involved" kratom use, additional adverse effects associated with its use have been found, and that Public Health Assessment via Structural Evaluation (PHASE) "3-D computer technology" has been used to analyze the chemical compounds in kratom:

Using this computational model, scientists at the FDA first analyzed the chemical structures of the 25 most prevalent compounds in kratom. From this analysis, the agency concluded that all of the compounds share the most structural similarities with controlled opioid analgesics, such as morphine derivatives.

The FDA continues to discourage the use of kratom, which it is calling an opioid.

Politics: FDA Has Named Names of Pharma Companies Blocking Cheaper Generics [Updated] 50 comments

Submitted via IRC for Runaway1956

Update 5/17/2018: The FDA has now launched the website listing the names of brand name drugs and their makers who have stood in the way of generic drug companies trying to make more affordable alternatives. You can view the list here. It includes notable medications, such as Accutane (for acne), Methadone (used for opioid dependency), and Tracleer (to treat high blood pressure in the lungs). The brand name drug makers to be shamed includes big hitters such as Celgene Corp, GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, Gilead Sciences Inc, and Actelion Pharmaceuticals Ltd, now a Johnson & Johnson company. Our original story, published May 16, is unedited below.

The Food and Drug Administration plans this week to effectively begin publicly shaming brand-name drug companies that stand in the way of competitors trying to develop cheaper generic drugs.

FDA Commissioner Scott Gottlieb told reporters on Monday and Tuesday that the agency will unveil a website on Thursday, May 17 that names names of such companies. More specifically, the website will publicly reveal the identity of 50 branded drugs and their makers that have blocked generic development. The website will also be updated "on a continuous basis" to list additional names.

In fielding questions from reporters, Gottlieb denied that the effort was a form of public shaming. "I don't think this is publicly shaming," Gottlieb said, according to S&P Global Market Intelligence. "I think this is providing transparency in situations where we see certain obstacles to timely generic entry."

Source: https://arstechnica.com/science/2018/05/fda-to-start-naming-names-of-pharma-companies-blocking-cheaper-generics/


Original Submission

U.S. to Make More Drugs Easily Available, Cutting Role Docs Play 36 comments

Bloomberg:

Americans may soon be able to get cholesterol-lowering medications and other widely used prescription drugs without seeing a doctor, a first step in what could amount to sweeping changes to how patients access treatments for chronic conditions.

The Food and Drug Administration in a draft guideline on Tuesday outlined how such a status, which the agency said could help lower health-care costs, would work. Patients could answer questions on a mobile-phone app to help determine whether they should be able to access a medication without a prescription.

"Our hope is that the steps we're taking to advance this new, more modern framework will contribute to lower costs for our health care system overall and provide greater efficiency and empowerment for consumers by increasing the availability of certain products that would otherwise be available only by prescription," FDA Commissioner Scott Gottlieb said in a statement.

Order your drugs from a smartphone app.


Original Submission

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  • (Score: 5, Insightful) by bradley13 on Friday June 28 2019, @10:54AM (4 children)

    by bradley13 (3053) on Friday June 28 2019, @10:54AM (#860896) Homepage Journal

    Yep, back in the day (military procurement) I saw this all the time. General officer today, corporate executive tomorrow, government SES the day after, and the day after that back to industry. It also happens at lower levels, all the time.

    On the one hand, it's understandable: you're in an industry you understand, you're ready to move up, and this usually involves changing jobs. OTOH, you're interviewing for that next job while working on contracts with the organization you're negotiating with. The purest intentions in the world cannot prevent the appearance of impropriety. And most people do not have the purest intentions.

    The government really needs to put a simple non-compete clause into place: If you work for the government, you may not work in an industry role with any company your dealt with, or had influence over, for at least x years afterwards. And once hired, you cannot work with your ex-company, or have influence over their contracts, for the same kind of period. At the top levels, as in TFA, this amounts to an industry-wide prohibition.

    --
    Everyone is somebody else's weirdo.
    • (Score: 0) by Anonymous Coward on Friday June 28 2019, @12:58PM

      by Anonymous Coward on Friday June 28 2019, @12:58PM (#860909)

      Did he have stiff competition for the position?

    • (Score: 1, Interesting) by Anonymous Coward on Friday June 28 2019, @02:10PM (1 child)

      by Anonymous Coward on Friday June 28 2019, @02:10PM (#860924)

      This is crony corporatism, it has nothing to do with capitalism. It isn't hard to figure out. Follow this simple rule: Is the government heavily involved in the situation? Not capitalism.

      But you aren't meant to understand how the world actually works so it is easier to scam you.

      • (Score: 2) by dry on Saturday June 29 2019, @06:09AM

        by dry (223) on Saturday June 29 2019, @06:09AM (#861262) Journal

        It's people, in the form of corporations, using their capital to generate more capital, which is what capitalism is all about. Capitalism rewards efficiency, and it is more efficient to subvert the government then to make better products.
        Don't confuse a free market with capitalism as they're at odds.

    • (Score: 2) by DeathMonkey on Friday June 28 2019, @05:16PM

      by DeathMonkey (1380) on Friday June 28 2019, @05:16PM (#861003) Journal

      non-compete clause into place: If you work for the government, you may not work in an industry role with any company your dealt with, or had influence over, for at least x years afterwards.

      Especially if you work at a regulatory agency!

  • (Score: 5, Funny) by DeathMonkey on Friday June 28 2019, @05:21PM

    by DeathMonkey (1380) on Friday June 28 2019, @05:21PM (#861005) Journal

    Wow, a Trump appointee who isn't resigning in disgrace due to illegal or unethical behavior.

    I guess there's a first time for everything!

  • (Score: 3, Interesting) by edIII on Friday June 28 2019, @07:54PM (6 children)

    by edIII (791) on Friday June 28 2019, @07:54PM (#861083)

    I've been saying this for a long time. If you're going to FORCE injections on US Citizens then we have the MOTHER FUCKING RIGHT to go after those hell bound sons of bitches when something goes wrong.

    Yet we don't have the right, or the power. The only right we have is to become a statistic that some execufuck gets to weigh against profits. The FDA is bought and paid for, and Big Pharma is TOO-BIG-TO-FACE-CONSEQUENCES. There are no regulations or protections for US Citizens and we're constantly the victims of Big Pharma's avarice.

    So in the light of this rather transparent corruption, good people are supposed to just have blind trust in these people running the show? The science is absolutely solid, the products absolutely safe?

    People like this jackass need to be in prison.

    --
    Technically, lunchtime is at any moment. It's just a wave function.
    • (Score: 2) by DeathMonkey on Friday June 28 2019, @10:08PM (5 children)

      by DeathMonkey (1380) on Friday June 28 2019, @10:08PM (#861135) Journal

      If you're going to FORCE injections on US Citizens

      You are aware that we don't force injections in the US, right? (asking for clarity's sake, it's hard to tell these days)

      When people refer to immunization requirements and exemptions they're talking about school requirements. If you want to put your kid in with all the other kids then you need to follow the safety rules. If you don't want to do that feel free to homeschool.

      • (Score: 2) by DeathMonkey on Friday June 28 2019, @10:12PM

        by DeathMonkey (1380) on Friday June 28 2019, @10:12PM (#861136) Journal

        * And certain jobs that have specific disease risk factors.

      • (Score: 2) by edIII on Friday June 28 2019, @10:35PM (3 children)

        by edIII (791) on Friday June 28 2019, @10:35PM (#861143)

        My understanding is that the changing laws are requiring just that.

        --
        Technically, lunchtime is at any moment. It's just a wave function.
  • (Score: 1) by ChrisMaple on Saturday June 29 2019, @04:45AM

    by ChrisMaple (6964) on Saturday June 29 2019, @04:45AM (#861245)

    The FDA is routinely corrupt and so are the pharmaceutical manufacturers. The FDA has a long history of bad decisions, allowing bad drugs, forbidding good drugs, and arresting supplement manufacturers while violating their first amendment rights.

    The FDA should be disbanded. The only valid function of the government with regard to drugs is testing for purity and strength. Ex-FDA employees should have a lifetime prohibition of working in the industry.

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