Department of Health and Human Services

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Late yesterday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with deceptive ads[,]” as well as initiating rulemaking to “close the ‘adequate provision’ loophole[.]” Concurrently, the White House issued its own memorandum, commanding the Secretary of Health and Human Services to take actions “to the extent permitted by applicable law.”Continue Reading FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

Since the publication of our article on what to expect for stem cell regulation under the new administration, we’ve been closely monitoring the administration’s enhanced focus on the same. As discussed in greater length in that article, key players in the new administration, such as Health and Human Services (“HHS”) Secretary, Robert F. Kennedy, Jr. (“Secretary Kennedy”) – who spoke publicly about this initiative even before his appointment and, soon after he was appointed, assembled a roundtable of government and industry personnel to discuss ways to reduce the regulatory burden for stem cell therapies soon after he took office[1] – have been vocal about the need to lower barriers to market entry for stem cell manufacturers.Continue Reading What’s Going on with Human Cell and Tissue Products?