The Washington Post is reporting that FDA Commissioner Scott Gottlieb, M.D. is resigning. Gottlieb had only been at this post since May 2017 but has been pushing a number of initiatives across the industries in which the FDA regulates. Within the food industry, he has been supportive of taking additional policy steps to improve food safety oversight, and last year he revealed concern over some food recall practices.
“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” said HHS Secretary Alex Azar in a statement. “He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. …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.”
According to the Post article, Gottlieb wants to spend more time with his family, as he has been commuting between Washington and his home in Connecticut on a weekly basis. The article also reports that President Trump did not want Gottlieb to leave his post.
FDA has issued a final guidance that reviews the situations in which a company should warn the public about a voluntary food recall. This includes the appropriate timeframe for issuing the warning and what information a company should include in the warning. The guidance, “Public Warning and Notification of Recalls”, also discusses when the FDA may decide to take action to issue a public warning, should one that a company issues is not sufficient.
In an agency statement, FDA Commissioner Scott Gottlieb, MD., also addresses the buzz around folks feeling that there have been more recalls. “In actuality, for fiscal year 2018, there were a total of 7,420 recalls with 831 that were classified as the highest risk. That figure represents a five-year low in recalls. However, the reason why recall notices might seem to have increased is that our publicizing of these events has become more prominent,” said Gottlieb. “We’re routinely providing more information on recalls and other safety issues that have happened.” He added that the ability to detect, track and trace product issues has improved with the help of technology, including whole genome sequencing.
“Our labs are currently testing cutting-edge technology that can screen for multiple allergens simultaneously and even technology that shrinks the genetic testing of pathogens from machines that were once the size of an entire room to a device that’s smaller than many smart phones. We’ll also be working to improve product traceability by tapping into modern approaches, such as blockchain technology, to further advance our mission of protecting public health.” – Scott Gottlieb, M.D., FDA
In addition, the agency is looking at how new technologies can be used notify consumers about whether a product they purchased has been recalled.
FDA Commissioner Scott Gottlieb, M.D., announced the next steps in their approach to implement the Produce Safety Rule that was established by FSMA. During the September 12th speech at the National Association of State Departments of Agriculture, Dr. Gottlieb outlined new measures the FDA will be taking, including compliance dates for agricultural water standards, recognized water-testing methods, and inspections related to non-water requirements of the produce rule.
According to the press release, Dr. Gottlieb also announced steps the FDA will take to “address concerns related to the complexity and feasibility of implementing standards for agricultural water.” One proposed rule concerning agricultural water compliance dates, if finalized, would extend compliance dates by up to four years for produce other than sprouts.
The press release states the reasoning behind this change is allowing the FDA to revisit those standards, ensuring they are implementable for farmers across the country. Sprouts are an exception here because of their high risk for contamination and will remain subject to original compliance dates.
The announcement also covered key changes to produce farm inspections, water testing methods and training opportunities for producers and regulators. For more information, see the press release here and the full text of Dr. Gottlieb’s speech here.
Yesterday Scott Gottlieb, M.D., President Trump’s nominee who has been criticized for his ties to the pharmaceutical industry, was confirmed by the Senate to lead FDA as its next commissioner. The vote was 57 to 42.
Gottlieb has extensive experience in healthcare and has been outspoke about the long approval process, along with the Medicare coverage process. However, he has not been vocal about food safety issues, so his impact on the food industry remains to be seen.
He previously served as deputy commissioner for medical and scientific affairs during the George W. Bush administration and was most recently a fellow at the American Enterprise Institute, a venture fund that invests in life sciences, medical technology and healthcare services.