So I had an epiphany last night—I was thinking about why more FDA lawyers do not get involved in helping Congress or FDA with developing legislation, regulations, and guidances to help FDA do its business. Sure, FDA lawyers will draft comments for a client or propose legislative provisions or language that benefits a client, sometimes gratuitously beforehand to generate interest, but how often are those comments actually the comments of the attorneys themselves?

In the context of the bar association section that I Chair, the Food, Drug and Cosmetic Law Section of the New York State Bar Association (NYSBA), we just submitted what I believe to be our first comments our section submitted to FDA on any topic. We did this as a joint comment with NYSBA’s Health Law Section, specifically the Committee on Medical Research and Biotechnology. Our comment was on FDA’s new framework for laboratory developed tests (LDTs), in part because New York had been regulating LDTs for decades already. But why did it take so long for our section to submit comments to FDA on any topic?

Our Section has been in existence since 1945—one of NYSBA’s oldest sections (NYSBA dates back to 1876), which is just after the Public Health Service Act (1944), and is before the Kefauver-Harris Amendments of 1962 that added efficacy to FDA’s regulatory authorities, before the regulation of animal drugs (1968), before medical devices (1976), before the Hatch-Waxman Amendments (1984) that gave us generic drugs and patent term restoration, before the newer regulation of tobacco (2009) or biosimilars (2010), and before many of the Acts that make FDA what it is today. Yet while my predecessors helped encourage the formation of a Food and Drug Committee within the Administrative Law Section of the American Bar Association, no other state bar seemed to follow suit. Again, I ask, why is this so?

I submit the reason is that as FDA attorneys, we are so focused on advocating and representing our clients’ interests that we forget or are fearful to provide our own viewpoints on regulatory or legislative initiatives that concern FDA’s regulatory oversight, even under the auspices of a bar association. True, many FDA attorneys will become further educated or speak at continuing legal education (CLE) or other conference-type events, but these events are educational and are generally not designed to have a direct impact on FDA rulemaking.

As the new Chair of NYSBA’s Food, Drug and Cosmetic Section, I attended a training for Section leaders, where it was emphasized that one of the hallmarks of a bar association is the ability for lawyers to make a difference by getting involved in the legislative process, to use our collective legal knowledge in our respective fields to help improve the laws of our country. Lawyers in fields such as antitrust, trusts and estates, intellectual property and other disciplines do this all the time through their respective state bar associations—why not FDA law? Unlike conference- or publication-oriented organizations, where the organizations themselves cannot make recommendations to FDA or the state or federal legislature, sections of bar associations can make such recommendations to current or proposed legislation, regulations, or guidances. Here is where the rubber meets the road and lawyers can make a difference devoid of a client or industry organization’s position based on their experiences interpreting and working within those legal constructs. In fact, many legal bar organizations, such as NYSBA, permit lawyers that are admitted in any jurisdiction to join and participate in the bar’s activities.

So, to my epiphany, I ask my fellow FDA lawyers to seek opportunities within their bar associations or similar venues that help to improve the laws in which FDA operates, both formally and through regulation and guidances. Do not sit back and wait for a client to provide you with the opportunity to speak your mind. Help FDA do its job better by actively commenting on proposed legislative initiatives, regulations, or guidances, and, of course, continue to advocate effectively for your clients.