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President Trump has selected Scott Gottlieb to head the Food and Drug Administration (FDA) and is more than likely to be confirmed by the Senate. Gottlieb has served in some roles within the Pharmaceutical industry including consultant, investor, board member, previous positions with the FDA and is a practicing physician with a history of editor roles for medical journals. Med City News has the full breakdown of Gottlieb’s background:

  • Has previously/currently invested in over 188 health care companies
  • Has served/currently serves on eight boards of directors that include cancer treatment development and glycemic management tools for diabetic patients
  • Consulted/consulting with eight pharmaceutical companies. The list of businesses includes GlaxoSmithKline (GSK), Daiichi, Valeant, Pfizer, and more
  • Previously was the FDA’s deputy commissioner for medical and scientific affairs under former President George W. Bush
  • Gottlieb was a staff writer for the British Medical Journal for seven years and went on to become an editor in the Pulse section of the Journal of the American Medical Association (JAMA)
  • Gottlieb has testified before Congress as an Expert Witness 18 times. His testimony related to drug prices, changing the drug approvals process, and matters related to vaccines

Pharmaceutical companies and current FDA deputies are onboard with Gottlieb’s appointment, as he is a noncontroversial and safe person for the position. From FierceBiotech, Nick Paul Taylor wrote that Gottlieb wants to drive down the cost of drugs by shifting the role of gatekeeper from the FDA to that of treating physicians. The FDA has taken a fast and flexible approach to cancer drug evidence, and Gottlieb would like the other divisions to follow suit. Gottlieb has championed the viewpoint of requiring more transparency from the FDA regarding its decision-making process.

Gottlieb has drawn criticism from advocacy groups worry about his deep ties to pharma, and they also worry that deregulation of the FDA’s approvals process would be detrimental to public health. Former FDA head, Robert Califf, received the same criticism for his ties to the industry. The now former FDA head opined in a recent article that a quicker approvals process does not require a cheaper drug make. Development costs would decrease, but it could be at the expense of efficacy. A shortened clinical trial phase could increase risks of patients receiving unsafe drugs. Califf supported the stance of using “real world” evidence, meaning, evidence and benefits collected from patient use.

Ultimately, as Califf said, the FDA is understaffed and overworked. New drugs and treatments approvals require the right personnel, and before the hiring freeze introduced by current President Trump, hundreds of openings remain vacant.

Much like clinical trial data, the effects of Gottlieb’s proposed deregulation of generic drugs has to go into effect before it can be measured. One of the core stances taken by Trump during his election campaign related to drug costs and the introduction of more competition to current manufacturers to foster a “bidding war” approach. As Vox wrote, Trump would like to usher in a “golden age” of drug development through simplification and reduction of FDA regulations and guidance.

Though the clinical trials and approvals process may change, complying with current Good Manufacturing Practices (cGMPs) has remained throughout the pendulum shift in politics. InstantGMP™ PRO is affordable, paperless, interactive, FDA compliant batch management software that can help your organization reach its next level of quality, operations, and much more. Check out our 30-second introduction video and sign up for a live demonstration to see InstantGMP™ PRO in action.

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