As Scott Gottlieb prepares to step down from his role as commissioner of the U.S. Food and Drug Administration (FDA), he sat down with Politico to talk about his two years at the helm of the regulatory agency and what regrets he may be leaving behind.

Gottlieb announced his resignation from the FDA earlier this month. The popular and proactive commissioner said he wanted to spend more time with his family. He said it became difficult commuting from his home in Connecticut to Washington for two straight years became hard for him. Since taking over the role of commissioner in May 2017, Gottlieb has aggressively supported the approval of new branded drugs, as well as generics. Additionally, he has taken on multiple public health problems including the opioid epidemic sweeping the country and vaping.

Gottlieb said he loved his job and it was actually a difficult decision for him to make. He said he had some post-resignation concerns over his decision but felt that being with his family more than on the weekends outweighed those concerns.

With the end of his tenure in sight, Gottlieb reflected on some of the high points of his tenure, including his work to regulate e-cigarettes and medical devices. One of the health issues that became a predominant concern during his time as commissioner is the opioid crisis. When Gottlieb was sworn in as FDA Commissioner in 2017, he pointed to the opioid abuse issue as one of the key crises facing the country. Politico reporter Dan Diamond questioned the FDA’s decision to approve a powerful new sublingual opioid medication in November. Developed by AcelRx Pharmaceuticals, Dsuvia was approved for the management of acute pain in adults that is severe enough to require an analgesic in certified medically supervised healthcare settings. In a defense of the agency’s decision following the approval, Gottlieb said the FDA should consider the approval of new opioid pain medications that can help fill targeted medical needs. In speaking with Diamond, Gottlieb pointed to the sublingual design of Dsuvia as a means to treat a patient who may not be able to be treated intravenously. He said its delivery could be life-saving in certain situations. Also, Gottlieb said the FDA had an arrangement with the U.S. Department of Defense to prioritize certain medications that have battlefield implications. He said Dsuvia was one of those medications that the Pentagon was highly interested in seeing approved.

Gottlieb noted that there had been efforts to strip the FDA of its regulatory authority when it came to products intended for the battlefield. He said the agency worked out a plan with the Pentagon to prioritize the medications that could have use in a theater of war because he felt it was still critical for the FDA to play a role in ensuring medicines approved for soldiers were safe and effective. That arrangement affected the process by which Dsuvia was developed but not in the way it was reviewed or assessed by the agency.

Gottlieb said it is reasonable that people raised concerns over the approval of opioids considering the crisis going on in the country. He said there could be policy setting that could be implemented to address future approvals of opioids and the risks associated with them. One area he said he looks forward to seeing with opioid is the use of one or two-day blister packs for opioid prescribing. He said that type of packaging and prescribing level will go a long way to reducing the number of opioids left in people’s medicine cabinets.

When Gottlieb steps down, National Cancer Institute (NCI) Director Norman “Ned” Sharpless will take over the role as acting commissioner. Gottlieb said he’s highly capable and competent. He noted that Sharpless has a good ethic to run the agency and is “deeply public health-minded.”

 

 

BioSpace source:

https://www.biospace.com/article/gottlieb-reflects-on-his-time-as-fda-commissioner-approval-of-dsuvio-during-the-opioid-crisis