The Senate on Tuesday voted 57-42 to confirm President Trump's nominee for FDA commissioner, Scott Gottlieb.
Gottlieb, a physician, has spent much of his career working in the pharmaceutical and health care industries, which some experts and Democratic lawmakers say presents the possibility for several conflicts of interest, while others say his background better equips him for the job. In financial disclosure documents released in March, Gottlieb said he would recuse himself for one year from FDA decisions regarding more than 20 companies he has been tied to financially.
As FDA commissioner, Gottlieb will be responsible for implementing Trump's plan to scale back regulations at the agency, which oversees safety and product approvals for everything from prescription drugs and medical devices to tobacco, food, and cosmetics. He also will play a key role in implementing the 21st Century Cures Act, which among other things requires FDA to accelerate and modernize its approval processes, STAT News reports.
During his confirmation hearings, Gottlieb said, if confirmed, he would "lead the FDA as an impartial and passionate advocate for public health." He added, "I'll be guided by the scientific rigor that the public deserves."
Gottlieb also told senators that addressing the nation's opioid misuse epidemic would be his top priority. He said FDA was "complicit, even if unwittingly," in helping to fuel the epidemic and that new strategies must be developed to increase access to non-addictive alternative painkillers and new treatments for opioid use disorders.
In regard to rising prescription drug prices, Gottlieb said FDA should take regulatory action to more quickly improve lower-cost generics for complex formulation drugs, such as those used topically or with inhalers.
Gottlieb also weighed in on vaccine safety, saying science has proven that vaccines do not cause autism, and that policy should move forward based on that data. "This is one of the most exhaustively studied questions in scientific history," Gottlieb said, adding, "I think we need to come to the point where we can accept 'No' for an answer, and come to the conclusion that there is no causal link between vaccinations and autism" (Frieden, MedPage Today, 5/9; Kaplan, STAT News, 5/9; Dickson, Modern Healthcare, 5/9).
Learn the 8 steps for deploying clinical pharmacists in ambulatory care
As the number of medications rises, so does the opportunity for medication errors, such as incorrect dosages, drug interactions, and serious side effects. By some estimates, the U.S. spends as much money correcting these medications problems as we do on the drugs themselves.
Check out our infographic to learn eight steps for how to deploy clinical pharmacists in outpatient clinics.