Remembering Peter Barton Hutt, an icon of FDA law

Hutt shaped FDA’s approach to the law in the 1970s, helped craft food and drug law for decades, and made the law come alive for thousands of students

Peter Barton Hutt, an FDA law icon, died this week at 91. Hutt accomplished a great deal, but was far more important for who he was than what he did. He was an ebullient, generous, compassionate man in a city and profession where those qualities are in short supply. He loved life, food and drug law, and people.

As the agency’s Chief Counsel in 1971-75, Hutt brought the agency’s operations into the modern era, first interpreting the law to allow it to issue legally binding regulations, and then using that authority to underpin regulations that continue to define food and drug law.

Many of the features of FDA law that are taken for granted today can be traced back to Hutt. The adequate and well-controlled investigation standard, which survived because Hutt won four Supreme Court cases upholding it in 1973. The off-label doctrine that allows a physician to lawfully prescribe an FDA-approved drug for an unapproved use. Nutrition labeling on foods.

After leaving FDA, Hutt played a role in shaping every major revision of the Food, Drug and Cosmetic Act, including negotiating the 1984 Hatch-Waxman Act for the Pharmaceutical Manufacturers Association (now PhRMA). In 2022, Hutt told BioCentury that negotiating with then-Rep. Henry Waxman “was one of the most distasteful things I have ever had to do in my life.” In the end, he believed that the deal favored generics companies. “When it was through, I recommended that the industry refuse to go through with what Waxman demanded, but [pharmaceutical companies] felt they had to” go along with it.

Hutt was the intellectual engine for the FDA Modernization Act of 1997, worked with congressional staff on the Orphan Drug Act of 1983 and advised Congress on the 21st Century Cures Act.

In 1999, following FDA losses in a series of First Amendment cases, Hutt told BioCentury: “FDA does two things — it regulates substances and words.” He predicted that the cases would upend FDA, noting that FDA has “said for nearly a century that the First Amendment doesn’t apply to it.” He was right.

Hutt’s writing and teaching were as influential as his legal work. He was the lead co-author of Food and Drug Law, the standard casebook used by every food and drug lawyer. Through decades of teaching at Harvard Law School and his writing, he touched the careers of thousands of attorneys.

Time was as kind to Peter as he was to his students, colleagues, and friends. He married in 2009 at 74, reading at the wedding ceremony from a book his 104-year-old mother had written at 95. As the sun was setting at a rooftop reception a decade later, he excused himself, telling a BioCentury editor that he needed to answer a few more emails.