News & Press Releases

Acting U.S. Food and Drug Administration Commissioner Ned Sharpless told agency staff in an email on July 23 that his top priorities are to develop frameworks for regulating new technologies; invest in the agency's workforce; help to lower drug prices by encouraging drug competition; and improve postmarket surveillance of regulated products. In an article published by Inside Health Policy, ML Strategies Senior Director Aaron Josephson commented extensively on Sharpless’ priority list.

A July 8 article published by The Boston Globe reported that the New England Aquarium is aiming to become a bold advocate on environmental matters, in conjunction with its plans for significant expansion.

Mintz Member and Chair of the Energy & Sustainability practice Tom Burton, Chair-Elect of the New England Aquarium Board of Trustees, recently led the search committee for the aquarium’s chief executive, Vikki Spruill, a longtime advocate for marine conservation. “Board members believe the nonprofit needs to forcefully advocate for conservation measures, and educate the public about what they can do,” Mr. Burton said.

The article also noted that ML Strategies is registered to represent the aquarium with respect to waterfront development on and around Central Wharf.

On June 12, MedCityNews published an article authored by Senior Director of ML Strategies Aaron Josephson addressing challenges faced by the U.S. Food and Drug Administration (FDA)’s Pre-Certification (“Pre-Cert”) program. The Pre-Cert program would revolutionize regulation and oversight of certain medical devices.




In the article, Mr. Josephson remarks that, “establishing a new regulatory paradigm for complex medical technologies is no easy task.” The pilot program has already raised a number of concerns among smaller companies, including the high cost and value related to the number of products developed. Despite the preliminary issues and uncertainty from Congress, Mr. Josephson maintains that, “the FDA should be applauded for taking proactive steps to create a regulatory climate that balances innovation and safety.”

Nancy Sterling, Senior Vice President, Strategic Communications at ML Strategies, shares her insights around crisis communication in this Q&A with PRSA Boston Buzz.

ML Strategies Senior Director Aaron Josephson is featured in this article, which discusses a memo by the White House Office of Management and Budget that requires federal agencies submit non-binding guidance to the Office of Information and Regulatory Affairs -- and potentially to Congress – that could throw a wrench in FDA’s usual guidance-making process, which could negatively affect both the agency and industry.