Drug Approvals, Off-Label Promotion Among Concerns About Trump’s FDA Nominee

President Donald Trump’s pick to head the FDA is spurring concerns about drug approvals and off-label promotion.

Trump March 10 nominated Scott Gottlieb to be the commissioner of the Food and Drug Administration. The nomination was widely praised by drug and device industry groups, but a consumer group and other stakeholders told Bloomberg BNA they are concerned that Gottlieb, who is a resident fellow at the American Enterprise Institute and previously worked at the agency as a deputy commissioner, has advocated for quicker drug approvals with less evidence and wants to loosen restrictions on off-label promotion of drugs and medical devices. Critics of the nomination also are concerned that Gottlieb is too closely tied to industry.

The next step in the confirmation process is for the Senate Health, Education, Labor and Pensions Committee to hold a hearing on Gottlieb. A date for the hearing hasn’t been set yet.

Gottlieb has advocated for faster drug approvals and “having the FDA tolerate more uncertainty about whether drugs are safe and effective for their proposed uses,” Michael Carome, director of Public Citizen’s Health Research Group, told me. “Tolerating more uncertainty means basically approving everything faster with less evidence” and “that’s a major concern.”

Also, Gottlieb “has advocated for loosening restrictions on communications from drug and medical device manufacturers on off-label uses of their products,” Carome said. Gottlieb favors allowing more communication on off-label uses and “we think the agency already allows too much” communication.

There is also a concern that Gottlieb is too closely tied to the drug industry.

“Like many of President Trump’s other nominees, Scott Gottlieb has extensive financial ties to the industries he’d be in charge of regulating and has shown more interest in reducing regulations rather than enforcing them,” Diana Zuckerman, president of the National Center for Health Research, told me.

Read my full article here.

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