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New FDA Head Selected by President

Scott Gottlieb, M.D. Food Safety News

Mesh Medical Device News Desk, March 14, 2017 ~ According to the New York Times, Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards.

Dr. Scott Gottlieb, M.D., 44, has ties to pharmaceutical and biotech companies and is a partner at a large venture capital fund, which funds medical startups.

 

WHO IS SCOTT GOTTLIEB? 

Gottlieb is a fellow at the American Enterprise Institute, a conservative think tank based in Washington, D.C., where he researched the FDA and medical reform. The group believes in limited government and personal responsibility.

He is a clinical assistant professor at New York University school of Medicine. Gottlieb was the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007.

Echoing Mr. Trump’s push to bring major changes to the way the FDA does business, including accelerating the process of approving new prescription drugs, Dr. Gottlieb has written about the FDA’s “cumbersome drug approval process.”

“Dr. Gottlieb is someone who has an unprecedented web of financial ties and conflicts of interest to the pharmaceutical industry,” Dr. Michael Carome, director of the Public Citizen’s Health Research Group, told Vocativ

At the FDA, Carome says Gottlieb often had to recuse himself from decisions. That no doubt would increase if he headed the FDA.

Writing for the American Enterprise Institute, Gottlieb has argued that speeding the drug approval process would slow the rising drug costs by promoting competition between manufacturers.

Dorothy Hamill in Vioxx ad

 

BACKGROUND

Mesh News Desk (MND) readers already know that 95% of medical devices get to market within about 90 days, so a fast-track clearance process is already in place for most medical device manufacturers.

Congress toughened the way drugs are approved after the Thalidomide crisis in the 1960. The drug was taken by women for nausea during pregnancy but led to severe birth defects. After that debacle the FDA tightened the safety of food and drugs, not medical devices.

Drugs that passed the FDA pre-market approval and clinical trials include the painkiller, Vioxx, which was the subject of intense litigation and a $4.8 billion settlement after at least 2,800 people lost their lives.

Mr. Trump also had Jim O’Neill on his short list to head the agency. O’Neill, a libertarian, used to work at Health and Human Services and has argued that drugs should be introduced into the market without clinical trials and let consumers test them.    He is connected to a firm that is working on anti-aging research.

There is currently a presidential freeze on hiring at the FDA. Drug industry leaders tell the New York Times, if drug companies want faster and new kinds of clinical trials approved, they need to fill the estimated 1,000 staff vacancies so decisions can be made more quickly.  ###

 

 

9 Comments

  1. D says:

    What does this mean in regard to mesh? How will they do medical devices?

    • Jane Akre says:

      It means we are entering a government where less regulation is best. Who wants that? Business who are regulated of course! When it comes to medical devices they are already treated with such a long leash that less regulation is almost unimaginable. Just put it on the market with no clearance at all and see what happens? In essence, the population becomes test rats….. already happened with mesh, I know.

  2. daniee says:

    I believe in regulations, specially when you have in your hands the health and lives of millions of people.

    If the FDA is not going to implement the regulations they are aim for, then what is the purpose of having them on the first place.

    • Jane Akre says:

      Good question

      • Diva64 says:

        I thought the purpose of Goverment is for the people….. Fast tracking medical devices and prescription medications is not For THE People, it is for businesses greed.
        The protection of patients and health care medical devices should be a top priority. Why do we have a military to protect the people if your risking lives and limbs on other soil to Protect The People, The elected officials can’t talk out of one their mouths and opposite orifices at the same time and fast tracking medical devices and pharmaceutical is talking out of both.
        Personally I think we have to protect people on our own soil to even think we can protect the People in the US on any other soil. Greed is what got the US in the situation it is in to begin with. Does anyone working for our newly elected President want their family members treated with fast tracked medical devices and pharmecticala being tested on their family members with all the recalls and medical defective devices already out . All the bad drugs already out. Why would they fast track anything medically. Only for $$$ before medical quality care.

  3. dear Jane i had a tvt bladder mesh put in . in 2004 i have saw nothing but hell out it seance it drawled my bladder up like a prune they wont me on Botox shots i haven’t had a sex life in years it destroyed my marriage i keep a bad infection i cant get read of. the bad order that comes from me nothing helps now my lawyer tells mt mine inset the kind they recalled because i dident have it took out . i never nowed i could get took out i dint no how to go about doing it but i intend to get it done some ways even thow they clam i dont have a cass what should i do i just dont no do you thank i should get something

  4. Disgusted says:

    What a scary state of affairs. On one hand the right is correct when it states that red tape slows them down. I was in the military for 7 1/2 years and saw government bureaucracy at its best. On the other hand, less regulation makes for more problems because human nature is selfish and greedy. Always looking for short cuts. It is hoped that people will do their best for patients. We have not seen it. The problem lies in the moral fabric of our country. Honesty and integrity are not valued as they should be. In my opinion many laws were broken when transvaginal mesh was brought to market. No current law is being enforced and criminal sanctions have not been sought out. It baffles the mind that severe complications were known ahead of time and ignored. Idiots all. This is why I think more laws will not help. They are already ignoring regulations. I think there should be more oversite. I think mass torts should be criminalized. This would definitely make them think twice before continuing business as usual. Not as easy as putting money aside for fallout. I know they argue “creativity” would be jeopardized. Because the manufacturer would be afraid of repercussions and new products that “help” people wouldn’t come on the market. There should be tension here. These should not be easy decisions. The nuclear power industry has a good model. They have an internal force that polices each plant and keeps them on their toes. Then they have the NRC (Nuclear Regulatory Commission) which puts plants on notice and even shuts them down if they are in unsafe condition. This has kept nuclear power safe since 3 mile island. Of course, the corporations do not want this, less profitable overall. Business as usual will lead to more heartache guaranteed.

    • Jane Akre says:

      Innovation is the code word for expansion, fast tracked medical devices…. This is not what Americans want! Interesting how civilization we think of a primitive..ed, think about the “common good” what works for everyone… and for the next generations. Leave things better than you found them. One would home humans would be evolving but we actually may be devolving….scary indeed.

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