In his first “all hands” speech at the US Food and Drug Administration’s (FDA) White Oak campus on Tuesday, Acting Commissioner Ned Sharpless explained how he will pick up where Scott Gottlieb left off, and how next week, FDA will launch a new and improved FDA.gov website.
“The work done over the past year to get us here will provide a more accessible, user-friendly site for the public to learn about recalls, get product safety alerts, and other important information about the work we do to protect the public. This will be important,” Sharpless, the former director of the National Cancer Institute (NCI), said.
While praising FDA’s “strong institutional culture,” he also noted FDA’s challenges with respect to regulating new and rapidly changing products, including electronic nicotine devices, gene therapies and CBD oil.
As far as his plans moving forward, he said he’s “not planning any radical changes from what the FDA has been trying to accomplish.”
With a reliance on science and the agency’s mission of protecting public health, he said he’s looking to continue to increase competition and reign in prescription drug costs through advances in generic drug
programs, develop new solutions for the opioid crisis, expedite the development of cell and gene therapies
and continue cracking down on dangerous stem cell clinics
He also said he’ll continue efforts related to FDA’s Medical Device Safety Action Plan, released last April
, and the digital health pre-certification pilot
“As NCI Director, I was a champion of the use of real-world evidence as a means to speed clinical trials, and therefore, I am excited by plans for the National Evaluation System for Health Technology (NEST), to advance the use of real-world evidence to support regulatory decision-making around novel devices,” he added.
Ingredient Advisory List
Sharpless also called to modernize and reform FDA’s oversight of the $40 billion dietary supplement market.
Just prior to his speech, FDA launched a new website
to alert the public when the agency becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements.
“As the dietary supplement marketplace has grown, the introduction of new ingredients often raises complex questions involving science, policy, and the law. In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful. This List is intended to get information to both consumers and industry more quickly. It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination,” said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas.
Also on Tuesday, FDA warned
eight companies for marketing dietary supplements containing DMHA
, and warned three companies for marketing dietary supplements containing phenibut
On 16 May, FDA is holding a public meeting
on innovation in dietary supplements.