The Administration’s Biggest Impacts on Pharma

Dr. William Soliman, CEO of The Accreditation Council for Medical Affairs (ACMA), spoke with Pharmaceutical Executive about how current events are impacting the pharma industry and what major issues could have a serious effect on medical affairs in the near future.

PE: In regard to the administration and the regulatory environment, what's having the biggest impact on Pharma?
Dr. William Soliman: I work with about 900 pharma companies and from what I’m hearing from them, the thing that’s having the biggest impact is the tariffs. Companies are worried about how those tariffs might impact manufacturing and pricing in the long term. That's one big area. The second big area is some of the stuff that Secretary Kennedy is trying to do at the Department of Health and Human Services (HHS). The main concern is the focus on vaccines and how they’re trying to look at what's appropriate in terms of giving patients vaccines.

For a long time, we've had a cadre, or a mix of different vaccines, we give everybody. Recently in the news, HHS issued a release that said Secretary Kennedy got rid of 17 different people on the vaccine committee and replaced them with a bunch of other people. The concern is, are those people biased, maybe, in a way that's anti-vaccine? What is that going to mean for Pharma?

And then the last area, I would say, is related to accelerated drug approvals. Last week, FDA commissioner Dr. Martin A. Makary announced priority vouchers to accelerate the approvals of different drugs in different areas including rare disease and oncology. For pharmaceutical companies, that's really important because that's going to shorten the window of time that they have to launch a drug.

Remember, prior to this, if a company was going to hire medical science liaisons, they would bring them in a year to 18 months before the drug was launched. Now, that time frame is shortened to one to two months. If you're a pharma company, you've got to be that much better when it comes to drug launches.

Those three things come to mind for me in terms of what I'm hearing from pharma manufacturers and what's top of mind to them.

PE: What is the current state of medical affairs and how can the industry adapt to the situation?
Soliman: Just today, I was talking to a woman who was the chief compliance officer over at AIG, which was the company that had a big hand, unfortunately, in the 2008 global financial crisis. We were talking about some of the work that we're doing in the financial sector in terms of compliance. Why I bring that up is that medical affairs has become really prime time when it comes to being the main function that educates doctors. It's medical science liaisons. If you look, the majority of the time that doctors have with the industry is with medical science liaisons, who get almost an hour with a doctor.

What’s impacting medical affairs today is the update to drug approvals: there’s more visibility, more scrutiny, and more complexity. The number one issue is the lack of good corporate governance.

If you don't have good governance within medical affairs for your field based medical team, that can put your organization at risk. The MSLs and medical affairs organizations are out there generating and communicating data, then responding to requests that come in for off label information from healthcare providers and making sure that there is a uniform standard across the organizations.

During my conversation with the former AIG chief compliance officer, she said companies and industries often don't take action until problem happens. AIG wasn’t thinking about compliance until the government came in to see what they were doing. We weren't thinking in pharma about the opioid crisis until it broke out. And now, what do we do in terms of how we educate doctors? So sometimes we wait too long until the problem breaks out.