June 20, 2022

Neuvivo Adds Former FDA Chief Counsel Peter Barton Hutt as Advisor

Palo Alto, CA, June 20, 2022: Neuvivo, a private late-clinical stage company developing an effective treatment for ALS and other neurodegenerative diseases, today announced it has added Peter Barton Hutt as advisor.  Peter is senior counsel in the Washington, DC law firm of Covington & Burling LLP, specializing in Food and Drug Law.  From 1971-75 Peter was the Chief Counsel for the FDA where he led the adoption of key regulations including a process to reevaluate the safety and efficacy of all biological products licensed in the last hundred years.

He was responsible for the legislation that became the Drug Listing Act of 1972 and the Medical Device Amendments of 1976.  He created the requirement of preambles for all FDA regulations, initiated the use of guidelines for informal FDA policy, and established the use of regulatory letters/warning letters.  Notably while at the agency, he wrote the proposed procedural regulations that govern all FDA administrative actions to this day.

“I am delighted to join Neuvivo as an advisor and work with the company to deliver a new, effective treatment for people living with ALS,” said Peter Barton Hutt. “It is a terrible disease, and often affects those who are very active and in the prime of life.  There are only two approved treatments available in the US today for this heterogeneous disease and I believe that NP001 has the potential to make a real difference in the lives of ALS patients.”

Peter worked with congressional staff on the Orphan Drug Act of 1983, the Drug Price Competition and Patent Term Restoration Act of 1994, and at the request of the House and Senate staff, he drafted the legislation that became the Food and Drug Administration Modernization Act of 1997.  He has continued to work on FDA-related legislation, most recently on the 21st Century Cures Act of 2017 and PDUFA VII.  He has testified before the House and Senate more than 100 times either as counsel accompanying a witness or as a witness.

Peter has been a member of the National Academy of Medicine since its formation in 1971 and served as a consultant to President Obama’s Council of Advisors on Science and Technology.  He has been a member of the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS and five Office of Technology Assessment advisory panels.  As a member of the FDA Science Review Subcommittee, he published a major analysis that resulted in Congress doubling FDA appropriations during 2008-2013.

For the past 29 consecutive years, Peter has taught a full course on Food and Drug Law at Harvard Law School.  He is the lead co-author of the text used to teach Food and Drug Law at law schools throughout the country.

He was named by The Washingtonian magazine as one of Washington's 100 most influential people; by the National Law Journal as one the 40 best health care lawyers in the United States; and by Global Counsel as the best FDA regulatory specialist in Washington, DC.  Peter was presented the Distinguished Alumni Award by FDA and the Lifetime Achievement Award for research advocacy by the Foundation for Biomedical Research.

“Peter’s background with the FDA and his expertise in regulatory matters is unparalleled,” said Ari Azhir, PhD, Founder and CEO of Neuvivo.  “We are pleased to formally welcome him to Neuvivo.  His excellent counsel and straightforward approach are valued, and we look forward to working together to make NP001 treatment broadly available to ALS patients as soon as possible.”

About Neuvivo: Neuvivo is a private, late-clinical stage biopharmaceutical company committed to creating and delivering advanced treatments for ALS and other neurodegenerative diseases.  The company was formed by industry leaders and scientists, committed to improving the prognosis for patients diagnosed with ALS and a range of diseases for which few current treatment options exist.  For more information please visit: www.Neuvivo.com.