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Gottlieb approved as FDA commissioner

Joe Mont | May 10, 2017

The Senate has confirmed President Donald J. Trump’s pick to head the Food and Drug Administration, Dr. Scott Gottlieb, by a 57-42 vote.

Gottlieb, confirmed on May 9, will oversee a staff of 15,000 at the agency, which is responsible for evaluating and approving pharmaceuticals and medical devises.

The new commissioner has held previous positions at the FDA. In 2005, Gottlieb was appointed the FDA’s Deputy Commissioner for Medical and Scientific Affairs. He also has served as a senior advisor to the FDA Commissioner, and as the agency’s Director of Medical Policy Development.

Gottlieb earned a B.A. in economics, from Wesleyan University and an M.D. from the Mount Sinai School of Medicine. His residency in internal medicine was at Mount Sinai Medical Center

In a statement, Senate health committee Chairman Lamar Alexander (R-Tenn.) suggested that Gottlieb’s leadership at the FDA “will help American families.”

“The FDA has always been important—but there has never been a more important time for the agency,” Alexander said. “Under Dr. Gottlieb’s leadership, the FDA can capitalize on the significant funding Congress has given to medical research and make sure that patients benefit from last year’s 21st Century Cures Act.”

That legislation authorized $6.3 billion in funding for the National Institutes of Health and other agencies. Among the its actions and goals:

  • Removing barriers to increased research collaboration.
  • Incorporating the patient perspective into the drug development and regulatory review process.
  • Measuring success and identifying diseases earlier through personalized medicine.
  • Modernizing clinical trials and allowing researchers to screen patients in advance to determine if their genetic predisposition makes them better candidates for targeted therapies.
  • Removing regulatory uncertainty for the development of new medical apps.
  • Providing new incentives for the development of drugs for rare diseases.

The bill included the Helping Families In Mental Health Crisis Act, a mental health reform bill.

“The FDA plays a central role in the approval of new drug treatments and therapies,” U.S. Senate Majority Leader Mitch McConnell (R-Ky.) said. “An important part of the 21st Century Cures Act provided an accelerated pathway for the FDA to approve regenerative medicines. I look forward to having a commissioner like Dr. Gottlieb who is committed to the development of groundbreaking medicines and treatments to combat serious illnesses… As a practicing physician with a wealth of policy experience, he has the necessary qualifications to lead the FDA at this critical time.”

“Additionally, the FDA will continue to be a crucial partner as states continue their fight against the opioid epidemic,” he added. “The FDA plays an important regulatory and oversight role in combatting this crisis.”

McConnell said he has encouraged the agency to incentivize the approval of “safer, more abuse deterrent formulations of drugs.”

“Dr. Gottlieb has the necessary experience to serve in this key role,” he concluded. “Not only has he worked in hospitals, interacting directly with those affected by disease and treatment, but he has also developed and analyzed medical policies in both the public and private sectors. He formed his perspectives on the dynamic public health sector by overseeing medical research and innovation projects.”

A less favorable view of the nominee was Sen. Edward Markey (D-Mass.).

“We are suffering a deadly opioid epidemic because the FDA approved dangerous and addictive painkillers, Big Pharma zealously pushed them, and doctors prescribed them with abandon,” he said. “With close and questionable ties to dozens of big pharmaceuticals companies, I have little faith that Dr. Gottlieb will do what is necessary as the leader of the FDA to end this vicious cycle of opioid addiction.”

 

 

 

“The Drug Enforcement Administration is our prescription drug cop-on-the-beat, but Dr. Scott Gottlieb wants to transfer that role to ineffective bureaucrats at the Department of Health and Human Services,” he added. “At the same time, he has also publicly stated his opposition to the FDA’s risk plans that are used to address the safety of opioid painkillers. These vital tools should be made stronger, but he argues that they shouldn’t exist at all.”

Gottlieb’s Big Pharma formula, according to Markey: “Take away DEA oversight over prescription opioids and at the same time, limit the FDA’s ability to utilize its full oversight authority over these addictive products.”

Earlier this month, Markey sent a letter to Gottlieb requesting details about the nature of the work and financial relationship he had with fentanyl manufacturer Cephalon, a pharmaceutical company under federal investigation for allegedly pushing doctors to prescribe the addictive painkiller for headaches and back pain when it was meant for late-stage cancer patients. A Washington Post story reported that Gottlieb advocated on behalf of Cephalon while he was previously employed at the FDA, in an attempt to increase the amount of fentanyl the manufacturer could produce. The DEA denied the request, finding that Cephalon and the FDA had no basis for this increased allotment.