60th Anniversary Q&A with Minnie Baylor-Henry
IA: We are celebrating 60 years of DIA, and you’re one of the luminaries and a former DIA President. Let’s begin at the beginning: Please introduce yourself, your career, and your current work.
After graduating, I worked in retail pharmacy, hospital pharmacy, and nursing home pharmacy. However, probably the thing that’s most unique about my career and the thing that I’m most proud of is that I owned a small apothecary shop in a medical building. The goal of owning a pharmacy began when I was maybe 13 or 14 years old. I saw my uncle working in his own pharmacy in Detroit and said to myself: I’m going to have one of those, one day. I also went to law school at night while working as a pharmacist in the day, which in hindsight sounds like a crazy ambition. But I decided I was going to do it and be a good pharmacist and a good law school night student at the same time.
I went to Catholic University’s Columbus School of Law. After four years at Catholic as a night law school student, I went to the Food and Drug Administration. The goal was to combine my background in pharmacy with my new legal training. I had heard from a friend that then-Commissioner David Kessler wanted to hire people into FDA with both law degrees and science degrees, which is also his background. I initially worked as a Reviewer in the Division of Drug Marketing, Advertising, and Communications (DDMAC). After a few years, I transferred to the FDA Office of Regulatory Affairs as FDA’s National Health Fraud Coordinator, which gave me an opportunity to work on health fraud issues not just within FDA but also with the State Attorneys General as well as the Federal Trade Commission. It was an interesting cross-governmental experience, and it allowed me to use more of my legal training, which was excellent experience for me.
DIA: Did FDA recruit you or did you target FDA specifically because you heard that Commissioner Kessler was interested in people with a legal background and a scientific background?
M B-H: Someone reached out to me and said I should consider the FDA. It was networking, I suppose: A fair number of FDA people had attended law school at night at Catholic University, so it was an easy transition. I became a Branch Chief in DDMAC for a couple of years and served as the Director of that group for nearly four years before I left to join Johnson & Johnson.
DIA: Why was J&J attracted to you as an FDA regulator joining their ranks?
M B-H: I was active and visible in being able to talk to companies about what was important in terms of adherence to the law, and I think J&J understood the importance of that. In the consumer sector of J&J, I was able to obtain a very different experience. As a pharmacist, I knew OTC products since I recommended OTC products to many consumers. But it was different to work on some of J&J’s OTC products. In the consumer sector, I had responsibility for regulatory as well as medical.
After staying in the consumer sector for nearly four years, I went to work for Deloitte & Touche. My primary reason was that I could work out of their Boston office because my husband had taken a job in Boston by that time. It was an attempt to work in the same city as my spouse! I was naive to the fact that you travel a lot as a consultant, and so I was traveling four days a week. However, the work was extremely interesting and varied.
Coincidentally, without any solicitation on my part, I was asked to come back to J&J. Once again, an opportunity to learn something new as Global VP, Regulatory Affairs, for the device sector. This was a global role and an opportunity to understand the global business of medical devices, with opportunities to interface with health authorities in other countries and to represent J&J to health authorities around the globe.
Somehow, there’s a misperception that medical devices are loosely regulated. It was an opportunity for J&J to position itself as embracing the importance of safe devices on the market and a really nice way to end my industry career. In 2015, I retired from J&J and started my own consulting practice, which is what I’ve been doing since then.
DIA: What initially attracted you to DIA, and what encouraged you to remain involved with DIA for so many years?
M B-H: I started at FDA in 1991 and shortly thereafter got involved with DIA, largely as a speaker because DIA had many programs during that time and FDA speakers were frequently requested.
At FDA, not everyone wanted to be a speaker. I liked doing it and I particularly liked speaking at DIA. As my career continued to advance at FDA, DIA became even more interested in senior-level people to speak. That’s how I got started. Shortly thereafter, you are invited to become a session chair for a particular program or to join the planning committee. However, it all started with speaking at and the planning of different programs.
DIA: Why were you interested in speaking for DIA as opposed to other organizations that might invite you?
M B-H: FDA was cautious about having its representatives speak. DIA programs were always collegial. I also liked that there was usually an international audience at DIA, which meant that there was opportunity to get to know people in similar roles from around the world, resulting in learning about global issues and global regulations and perspectives.
DIA: Was DIA’s professed culture of neutrality elemental in your decision (and comfort) in speaking at DIA?
M B-H: We’ve grappled with the neutrality issue for a very long time. The neutrality issue was certainly more important to speakers and health authorities outside the US than it was in the US, but FDA was not oblivious to it and did not want to be perceived as being so close to industry that they could not be impartial. The insistence on neutrality that some of the other speakers would ask about was certainly a higher priority than it was at FDA. My talks didn’t have to clear a neutrality hurdle. They had to clear the hurdle of truthful and not misleading, but we didn’t have to look at the composition of the audience or sponsorships, which I know was the case with some speakers from other countries.
DIA: What encouraged you to remain involved in DIA for these 25-plus years?
M B-H: Once you start getting involved, you get more engaged, and suddenly DIA begins to feel like family. It’s the kind of organization that you want to be part of and then you ask: What else can I do to help? What else can I do to make sure that “my” organization is successful? That’s how you begin to feel about DIA: It’s my organization.
To this day, when I give advice to individuals starting off in their career, I say you must get involved. If this is your career, and this is what you want to do, then you need to get involved, and you need to get involved with associations like DIA that will help shape your career. I haven’t retracted that advice yet. I continue to this day to believe that’s hugely important.
Networking and all those things are important. But there is something about DIA that goes beyond the networking piece: It is the learning elements. You come away from a DIA meeting knowing that you learned something new. Sure, you network, you get to meet friends from other countries or companies, but you also learn something about your field of interest. DIA has always had very thoughtful programs.
The other thing that I really appreciated about DIA was that it was multidisciplinary. There are organizations that focus on specific issues. But if you’re trying to understand the bigger picture, then DIA will have that for you, particularly at the Global Annual Meeting and the Annual Meetings in Europe, China, and Japan. You are going to understand from a big-picture perspective what’s going on in a particular area, not just the regulatory issues but also the clinical issues, the pharmacovigilance issues, and so forth. I always appreciated that about DIA because you have an opportunity to interface with many colleagues who are involved in every aspect of the development of a product.
DIA: What other key elements differentiate DIA?
M B-H: In addition to the multidisciplinary aspects of DIA, there was the ever-expanding global nature of DIA: truly global, not US and Europe only. There was a period when DIA continued to grow as a global organization encompassing Japan, China, Latin America, etc. The depth and breadth of the programming and the excitement around DIA programs in other countries was incredible. A country focus would perhaps start as a section of a program: A group of regulators from Japan, for example, would attend the global annual meeting, and that would grow from a single track at a single program into an Annual Meeting in Japan. This happened in country after country. There is a true appreciation and respect for being a truly global organization and not a US organization that happens to have one program once a year about all of Asia. DIA is truly a global organization.
DIA: Would you talk about your role and history as a leader within DIA?
M B-H: After being a speaker and serving on committees and as a session leader, I was invited to join the Board, and I was thrilled. I held lots of different Board positions: I was the Treasurer and at one time the Secretary. I have served as the Vice Chair of the Board and then the Chair of the Board, followed by Immediate Past Chair. I’ve probably held every position you can hold as a Board member. These leadership roles were opportunities to become part of DIA at an executive level at an exciting time for DIA. It was during that period we recruited our Global Chief Executive, Barbara Lopez-Kunz. I was proud to chair the Search Committee that resulted in Barbara joining DIA. I’m particularly proud of that because she was the right leader at the right time for DIA.
DIA: In your quarter-century-plus time in DIA, you’ve been involved in essentially half of DIA’s life. Have you seen a lot of change?
M B-H: That’s an interesting way of putting it, but I probably have been involved with 30 of the 60 years of DIA and maybe longer. We just talked about this true globalization of DIA that evolved over the years. The other thing that’s so interesting about DIA is this neutrality: While DIA grappled with what that means, as the years have gone on, there’s always been a way of finding that right middle ground. DIA has the respect of regulators around the world because DIA is viewed as a neutral forum, and that was always important to our colleagues around the world.
I also think DIA from a board perspective did a fine job of making sure the board represented the world. There were such rich discussions at the board level, whether it was a regulator from Germany, a regulator from Mexico, or a regulator from the US. The regulators respected those of us who worked in industry because we were all there to make DIA a better organization.
I am also a Fellow of DIA. It was also nice to see that health authorities and regulators could have a separate group and could exchange ideas in what is now known as the DIA Council of Regulators. They didn’t have to leave DIA to find a different forum for regulators to share ideas. It was a great idea.
DIA: Has DIA struggled with the right balance between convening important conversations and not taking sides in those conversations?
M B-H: It’s hard to say that DIA is anything but neutral just by putting the facts on the table. We talked about this endlessly. How broadly will DIA reach? Should it reach devices? Should it reach combination products? How all-encompassing should DIA be, and can DIA do a good job if it’s too broad? On the other hand, if DIA doesn’t encompass a broad portfolio of products and topics, then are we missing an opportunity to engage in the future and to be mindful of where is our industry moving? DIA has done a good job of staying ahead of the curve without biting off too much. Where do you draw the line? DIA has found that right balance between staying true to its mission and its scope without being too self-limiting.
DIA: How do you feel about the possibility that DIA begins to involve a constituency that has not typically been part of DIA: The payer constituency—“the final mile” to patients having access to the medicines and products they need?
M B-H: I’m okay with that. If you’re going to truly look at this as encompassing the big picture of how a product gets to marketplace, we can’t ignore the fact that there are payer issues. That’s an important conversation, and it will be interesting to see how deep DIA can go with that without compromising its neutrality. You don’t want to become a forum solely for insurance companies or pharmacy benefit managers. On the other hand, if you’re not engaged in the conversation about reimbursement and the rising costs of pharmaceuticals, you’re missing some of the hurdles to getting a product to patients. The fact that FDA is not involved in the cost of medicines per se is not a reason for DIA to ignore that issue because that’s important for many in the audience. I’m okay with the reimbursement issue because I think it must be spoken out loud.
DIA: We looked into the origins of DIA and observed that it was driven mostly by white American men, as founders and others. You’ve been a leader and you’ve seen things up close. Is there a particular aspect of DIA’s history that you believe deserves special recognition or celebration in this anniversary year?
M B-H: You only have to look at the “class pictures” from the annual meetings and other major meetings over the years. The answer is so obvious that it smacks you in the face. I certainly felt like DIA was my home as a black woman and never felt that I was being judged because I’m a woman or a person of color. I had a seat, and eventually a leadership seat, at that table. Like many organizations, DIA recognized the need to evolve.
DIA can be proud of the fact that if you looked around the board table, certainly during my years on the Board, there would be representation from Japan, China, Germany, Mexico, the US, females and males, and black and white. It did your heart good to see that level of representation with an organization. I would even venture to say that DIA probably had better representation than most organizations. That was not accidental but was by design. We recognized that we needed individuals at the table who were making a difference in pharmaceuticals and more recently medical devices and biologics globally. It’s part of the DNA of DIA.
I once again credit Barbara with making sure that the representation and the reputation of DIA was that of an organization that’s inclusive and welcoming. For example, Barbara was the one who insisted that Howard University students have a DIA chapter. I remember so clearly the first DIA meeting with Howard students. They were thrilled to be at DIA and were handing out their business cards and introducing themselves and I thought: “Look at this—this is the DIA of today.” If you look back 60 years, 50 years, 40 years, you would not have seen that same level of representation. But DIA has certainly had a big tent in the last 20 to 30 years, and it represents all of us who are trying to make a difference in our ecosystem. It’s the evolution of where things are for DIA.
Listen to Minnie’s closing message to DIA members for the next sixty years from her Q&A with Global Forum Editor-in-Chief Alberto Grignolo below.