FDA commissioner Scott Gottlieb is to resign in one month to spend more time with his family, he has announced.
Gottlieb
The news was confirmed by health and human services secretary, Alex Azar who praised Gottlieb’s leadership, stating that it led to ‘historic results from the FDA’.
For instance, in 2018 the FDA approved a record number of new drugs; the result of a push by Gottlieb at the start of his tenure to get more therapies approved to market faster.
Perhaps more importantly to patients was a push to get more generic drugs onto market. In February this year, Gottlieb announced that generic drugs accounted for 90% of US prescriptions in 2018. This was done to both increase market competition among pharma companies and improve patient access with more affordable drugs.
In his resignation letter, Gottlieb regarded tackling the opioid crisis as one of the FDA’s major priorities and achievements.
While the opioid crisis is still a major issue for the US, the FDA’s efforts involved working with the healthtech sector to advance new devices to help identify patients who might be risk of developing an addiction and that manage pain.
Indeed, Gottlieb’s relationship with the digital health sector could partly be responsible for the rise in medtech devices from the likes of major technology companies. Through the Digital Health Innovation Action Plan, the FDA sought to assess the regulatory framework around digital health products and offer guidance to developers. Alongside this, the FDA worked with tech companies including Apple, Fitbit and Johnson & Johnson to streamline the approval process for digital health products by assessing the developer, rather than the product.
Confirming Gottlieb’s resignation, health secretary Alex Azar said: “ All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family.
Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more. The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
Scott Whitaker, president and CEO of the Advanced Medical Technology Association (Advamed) thanked Gottlieb for his work at the FDA: “During his tenure as FDA commissioner, Dr. Gottlieb has been a tireless advocate for improved patient care and for promoting innovative solutions to our most pressing health challenges, including greater use of medtech to combat the opioid crises. We wish him well in his future endeavours,” Whitaker said.
Gottlieb didn’t give a specific reason for resigning other than wanting to spend more time with his family, though there have been reports that he was frustrated by the government shutdown that occurred in December.
While many have praised Gottlieb for his time at the FDA, consumer advocacy group Public Citizen has a differing opinion.
“Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner. Not surprisingly, his tenure as commissioner was marked by regulatory decision making regarding medications and medical devices that tilted further in favour of industry's financial interests rather than the interests of public health.
This includes the recent, reckless decision to approve the super-potent opioid, Dsuvia, and the withdrawal of a proposed rule that would have allowed generic drug companies to promptly update their labels with new warnings.
It's imperative, but sadly unlikely, that the next nominee for FDA commissioner be someone who is independent from industry ties and will make protection of public health the agency's top priority,” the group said in a statement.