FDA Gladiator: Larry R. Pilot (1940-2025)
[Obituary by Jim Dickinson, his friend] Back in the so-called Good Old Days before user fees leveled the playing field, FDA bureaucrats ruled the regulatory roost, secure in their Chevron USA v NRDC power to assert their will until one quiet-spoken lawyer defeated them in a little-noticed string of court cases. Pharmacist-attorney Larry Robert Pilot, who died this month aged 84, learned the agency’s inner workings as its first director of medical device compliance, a post he held for 10 years in the Bureau of Medical Devices (now the Center for Devices and Radiological Health). After leaving the agency, Pilot successfully turned this knowledge against FDA in such landmark cases as BioClinical (1988), Laerdal (1995) and Utah Medical (2004), at that time the only cases against a medical device company that FDA lost, showing that the agency isn’t the sole arbiter of how its quality regulations must be complied with.
Pilot graduated as a pharmacist from Detroit’s Wayne State University in 1962 and later as a JD lawyer from Catholic University in Washington while working as an intern at the American Pharmaceutical Association under the renowned William S. Apple. A staunch Republican, he then joined the staff of the Pharmaceutical Manufacturers Association (PMA, now PhRMA) headed by Apple’s close friend, C. Joseph Stetler. From this perch he moved to FDA in 1972 and helped establish its first Office of Medical Devices under David Link in the Bureau of Drugs. Those efforts helped secure passage of the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act. Link and Pilot then established the separate Bureau of Medical Devices at FDA to implement the new law, accomplishments memorialized in an internal 62-page FDA interview in December, 2004.
During this time, he met and on April 6, 1968 married the love of his life, Lynne Widlitz, also a lawyer, with whom he raised three children (Rob Pilot, Tracy Pilot Perkins and Brad Pilot). In the highly competitive, sometimes fractious Washington world of ex-FDA lawyers, Pilot avoided the legal limelight, working far from the headlines in smaller law firms. In this, he frequently tussled with but respected the widely revered longtime, Chevron-reliant FDA deputy chief counsel for litigation Eric M. Blumberg.
Although he usually shunned the limelight (unlike Blumberg), in 2006 Pilot showed he could put it to good effect when he addressed the annual Medical Device Quality Congress in San Diego. There, he gave 10 reasons why in his opinion FDA had lost Blumberg’s case against Utah Medical two years earlier. Federal judge Bruce S. Jenkins, a Democrat, had ruled that FDA was not the sole arbiter of how companies should follow its quality system and good manufacturing practice regulations, writing that, in his words, “many roads lead to Rome.”
As if to foretell last year’s Supreme Court decision overturning the Chevron deference doctrine that had propelled Blumberg to sue Utah Medical, Pilot’s 10 reasons in San Diego were that his former agency had: (1) Poorly trained investigators and associated personnel, (2) poor supervisory review, (3) a multi-level unwillingness to listen to, dialog with and understand the company, (4) a stubborn resistance to differences of opinion, (5) an internal inability to challenge lower-level decisions and recommendations, (6) no risk analysis, (7) an attitude of “We are always right” combined with a “gotcha” mentality and an ends-justifies-the-means philosophy, (8) an unwillingness to learn from mistakes, (9) a refusal to apply the same corrective and preventative actions to its own mistakes as it requires for industry, and (10) an absence of oversight from HHS, the Inspector General and Congress.
Many of these criticisms of the bureaucratic FDA culture remain valid today, although user fees have made a deep impression to reduce the agency’s “gotcha” mentality and the “We are always right” combativeness that Pilot fought against as an industry lawyer. From that perspective, his efforts and time have tamed the FDA tiger.
In his private life, Pilot maintained a long and close relationship with fellow Wayne State pharmacy alumnus Donald A. Dee, who remembers “Larry never did really ‘retire.’ He and Lynne purchased a home in Lexington Golf and Country Club in Fort. Myers FL, where they enjoyed several winter months each year. But he continued to work in representing clients in their legal needs throughout these winter ‘vacations.’
“Many times over the years, Larry and I would get together in Fort Myers for a Friday breakfast at a modest diner called Marti’s, which was located between our homes about eight miles apart. We bicycled to Marti’s with great regularity at 7:30AM and we would wrap up at 8:30AM, just as if he were billing a client. But he wasn’t. It was just his habit. … But Covid-19 put an end to our breakfasts at Marti’s, as it permanently changed and upended travel and restaurant availability. As a result, Larry and Lynne were unable to come to enjoy their Fort Myers home because of Covid and then Hurricane Ian (9/28/22), which flooded many homes in the area, including those of the Pilots and the Dees. …
“Among his other activities: Larry owned a vineyard and farm in Italy, a restaurant, real estate investments, an estate executor/trustee and more. A man of many interests and talents, indeed.
“Recently, Larry’s health deteriorated considerably and it has now been several years since we last visited in person. Nonetheless, we kept in touch regularly via phone and email, although recent communications with him grew increasingly difficult, as he struggled to find the words he wanted to use.
“Larry’s was a life well lived.”