- Stephen Hahn is confirmed by the Senate to head the FDA after a majority vote approval of 72 to 18
- The agency faces numerous challenges that the new commissioner will need to address, among them the CBD craze, youth vaping epidemic and importation of cheaper drugs
- His confirmation was received well by many Americans, with congratulatory messages from many top agencies, organizations and renowned associations.
The US Food and Drug Administration has a new boss after almost 8 months following the resignation of Scott Gottlieb earlier on in April 2019. The US Senate confirmed Dr. Stephen Hahn, a renowned radiation oncology expert and the chief medical executive of The University of Texas MD Anderson Cancer Center.
With a majority vote of 72 to 18 from the senate, Hahn,59, takes control of FDA amidst the current hurdles the administration faces. The ‘teenage vaping epidemic’ and the regulation of consumable and other products that contain CBD are chief among the issues he should expect to tackle head on.
The addition of Cannabidiol or CBD to consumable products is a crucial issue that the new commissioner needs to address. The pressure has been mounting ever since the congress passed the 2018 farm bill that legalized hemp, that facilitated for the wide availability of CBD that now manufacturers are infusing them everywhere. In states like Colorado, consumable CBD finds itself everywhere from CBD infused water to doughnut CBD, and the craze is getting out of hand. Authorities in Colorado as it is in other states are also calling out on the FDA for a more detailed federal regulation on this matter.
The authority recently served 15 companies with warning letters for illegally selling products that had CBD infused in them that were not approved for human use. As per the moment, the agency has only approved one product, Epidiolex, an epilepsy treatment medication, to have human consumable CBD. The agency also stated that it has a mission of exploring potential pathways for various types of CBD products to be lawfully marketed.
“The issue of CBD, is an active ingredient in the drug that was approved for very serious childhood disorder. I think that tells us that there is a pathway for medical products. And there are also some indications that cancer where CBD might be of benefit. But there are some open and unanswered questions that have to be filled by research. What’s the appropriate dose and for what indication?What are the implications of long term use? ,”Hahn replied.
ICYMI: yesterday, I asked the Admin’s FDA nominee about making it easier for researchers to study marijuana & see what other treatments could be derived from it—following the success of CBD as an ingredient in medicine to treat seizures in children with a severe form of epilepsy. pic.twitter.com/yvrRJfMlaI
— Senator Jacky Rosen (@SenJackyRosen) November 21, 2019
The new commissioner has largely been warmly received by most Americans with the Natural Products Association (NPA) President and CEO, Dr. Daniel Fabricant, Ph.D., offering his congratulatory message in a press statement.
“We look forward to working with Dr. Hahn and his staff to address much-needed regulation for cannabidiol (CBD) products and enforcement for adulterated dietary supplements,” he stated,
“Inaction to date in the CBD marketplace has created a scenario that may lead to CBD products being pulled from retail shelves and limiting access to CBD. With thousands of CBD products available in the marketplace and tens of thousands of Americans relying on CBD products, it’s time for FDA to set a safe level for daily CBD use. We hope they will look closely and follow the NPA-sponsored and House-passed legislative approach to CBD regulation pending in the Agriculture Appropriations conference committee, as it is the best pathway to protecting consumers and ensuring science-based rules for this promising ingredient.”
The American Association for Cancer Research (AACR) also offered a applauded Hahn in a similar press release stating,
“I wish to extend our heartfelt congratulations to Dr. Hahn. The AACR is looking forward to working closely with him and his extraordinary team at the FDA to help facilitate and expedite the development and approval of safe and effective treatments for cancer patients.”
Among the many issues that Hahn will be tackling, is the importation of prescription drugs from Canada as a means of reducing the financial strain on drugs. Though, for a long time the FDA has always had a firm stand against importation, some of officials at the Department of Health and Human Services seem not to concur and will be urging Hahn to be more accommodative. Former FDA boss, Scott Gottlieb has also been championing for this and recently shared his opinion on the new importation plan that was unveiled by Trump’s administration in a tweet.
On close review of the “importation” plan unveiled today, the proposed rule places stringent conditions on the importation of drugs. While it may sharply limit who can actually import Canadian drugs under this framework, it maintains critical FDA safeguards to protect consumers.
— Scott Gottlieb, MD (@ScottGottliebMD) December 18, 2019
The Teen Vaping Epidemic was also another bone of contention for the senators. Hahn expressed his stand on vaping in general stating that the current federal regulations were not under his purview but rather under the White House since by the time he would be in office, it would be beyond his powers to act on them. He though, acknowledged that it is a crisis in the country that needs aggressive tactics to stop it. His stand was not well received by anti-vaping enthusiasts that believe the new position should give him a more steadfast approach towards banning vaping in totality. In an op-ed to the CNBC, Vin Gupta, assistant professor of pulmonary and critical care medicine at the University of Washington, lashed at the senate terming his appointment as ‘a profound disregard for the literal health of our nation’.
Hahn now takes full stear of the FDA as the two interim directors leave office. Ned Sharpless took office since Gottlieb resignation in office and for headed the agency for the last 210 days as law stipulates. Dr. Brett Giroir, the assistant secretary for health at the US Department of Health and Human Services, took office from November 6th, and has led the authority until Hahn’s confirmation.