Peter Barton Hutt, former Chief Counsel at the FDA and pioneer of medical device regulatory policy, joins as Plan A™ concludes successful U.S. clinical trials.
Los Angeles, CA – August 27, 2025 – NEXT Life Sciences, the modern reproductive healthcare company pioneering Plan A™, a first-of-its-kind, long-lasting, and on-demand-reversible male contraceptive, announced today the addition of renowned FDA regulatory expert Peter Barton Hutt to its advisory board. Known as the “Father of Modern Drug Law,” Hutt served as Chief Counsel during the most influential years at the U.S. Food & Drug Administration where he helped shape many of the policies that still govern medical devices today. Hutt’s appointment strengthens an advisory board already composed of groundbreaking experts in male contraception.
During his time at the FDA, Hutt is credited for creating the foundational structures of our modern healthcare, such as the medical device legislative policy, the Over-the-Counter (OTC) drug review, and the food nutrition label. He helped establish the use of FDA Guidance to create informal FDA policy and key safety requirements for medical devices, such as Plan A. Hutt remains the only lawyer elected from private practice to the National Academy of Medicine and is a partner at the legendary legal firm Covington & Burling LLP. He is now bringing this experience to Plan A™ as NEXT Life Science continues along its clinical pathway, following two 100% successful trials in Canada and Australia earlier this year, and heading toward potential FDA approval.
“I am indebted to have had the distinct pleasure and privilege of Peter’s guidance throughout my career bringing lifesaving products to market. We are elated to have him join our advisory board,” said Darlene Walley, PhD, chief executive officer of NEXT Life Sciences. “As we continue to work to revolutionize male contraceptives, Peter’s experience is helping to establish a course of action for Plan ATM coming to market as soon as 2027.”
Plan A™ uses a proprietary hydrogel called Vasalgel®, which is designed to filter out sperm from the vas deferens while still allowing fluids to pass. Plan A™ is intended to last for more than 10 years and can be delivered quickly in a medical office and reversed on demand, equally as easily, with a simple solution to dissolve the hydrogel.
“I have learned throughout my career that you bet on people and Darlene is one of those,” Hutt said. “I’ve worked with Darlene every place that she’s ever gone and know that’s always a brilliant decision. Her dedication and intelligence are unmatched.”
Hutt added, “Many groups have tried for literally decades to create viable male birth control options and yet have not succeeded for various reasons. Plan A’s progress, including recent very promising clinical trials and patent approval, is quite encouraging. A male contraceptive will make a sizable impact on humankind.”
Currently, half of all pregnancies worldwide are unplanned, and over 17 million American men are actively seeking new contraceptive options that better align with their relationships, values, and lifestyles.
In addition to his legal work, Hutt is also a long-time lecturer on food and drug law at Harvard Law School and has written numerous scholarly articles as well as contributing to draft legislation.
To learn more or inquire about investment opportunities, contact info@planaformen.com.
About NEXT Life Sciences
NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product, Plan A™, a non-hormonal, long-lasting, and reversible male contraceptive. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status.
For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/.
Disclaimer
All forward-looking statements are not guarantees of future performance, and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.
