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The Regulatory Consequences of the Mifepristone Case: Q&A with Meg Alexander, Chief Strategy Officer at Ovid Therapeutics


Alexander discusses the broader implications the case could have on FDA's ability to regulate the industry.

Meg Alexander

Meg Alexander
Chief strategy officer
Ovid Therapeutics

The Supreme Court is set to hear a case that could have a huge impact on not just the availability of Mifepristone, but also the ability of FDA to regulate drug approvals. Meg Alexander, chief strategy officer at Ovid Therapeutics, spoke with Pharmaceutical Executive about the case and broader issues impacting the life sciences industry.

Pharmaceutical Executive: Can you describe your role?
Meg Alexander: It partly involves developing our short term and long-term strategies, but also overseeing the execution of the lead clinical development program. I oversee the corporate affairs function that has the traditional suite of functions that you’d anticipate, such as corporate affairs, community engagement, investor relations, government regulations, etc.

Stakeholder capitalism can sound a bit like an academic term, but fundamentally what we’re looking at is what is important for our strategy and how companies engage in our society to be able to preserve our license to operate and to be able to be effective. That is strategic as it’s important to our business.

It’s very important for any life sciences company, large or small, to be thinking about these topics because they are the topics shaping our society. They’re impacting our employees, the broader ecosystem, and the patients that we seek to serve.

PE: Can you discuss these broader issues?
Alexander: I’ll start with the why because I think that will help create a framework for where we’re choosing to engage or not. If you’re looking at it from the outside, this might not necessarily be evident.

It’s interesting, when I came into biotech and partnered with other executives to start engaging on issues that fell under stakeholder capitalism, some were accusing us of being woke. They described it as woke leadership or woke capitalism. Fundamentally, when you look at where leaders like me, my colleagues, and executives at other pharmaceutical organizations, it has three big threats that underpin it.

The first is that we very much want to mitigate vulnerability in our ecosystem. In the case of the Mifepristone situation, this is a fundamental case of defending the efficacy of the FDA, and to ensure that it is able to make scientific, safety, and medical decisions about whether or not medicines are allowed in the marketplace to treat humans. It’s very much about protecting the foundations and bedrock that allows our ecosystem to be successful.

The second piece is a bigger motivation to protect our license to operate. We’ve seen this with things like the inflation reduction act (IRA). We, as an industry, are set out and purpose driven to help people live longer and better. However, that is not how we’re being characterized in many societies right now. In order to protect our license to operate, it’s extremely important to be trustworthy and behave in trustworthy manners. That means acting beyond our self-interest, which is fundamentally why we were created in the first place. To be able to really serve the needs that our society has. There’s a lot of data that supports that.

Finally, most of know that at the end of the day, there’s a time when there’s a right thing to do. You know it when you see it.

I see this level of engagement as central to the preservation of our industry in the United States, and I’m fortunate to work with fantastic leaders who are willing to hold hands together on the right topics and engage, I think it will make a fundamental difference to go out and pursue the business that we got into in the first place.

That’s an important rational, because you could look at these topics, some of which are domestic and others are international, and try to figure out the why. Really what I’m saying is that this isn’t woke capitalism. This is coming back to what the right thing to do for our business, to preserve it, let it flourish, and let it serve the people we set out to do in the first place.

PE: Can you discuss the Mifepristone case?
Alexander: This is a case where you don’t need a trade association to help engage and make change. This is a true case of a coalition coming together of women leaders in the biotech industry, former heads of bio, lead investors from some of the biggest funds in biotech, and me and other executive leaders. The fundamental question is what the implications will be. What’s the risk?

This can fundamentally undermine the primacy of FDA to be able to adjudicate decisions about the safety and efficacy of medical systems. That’s deeply problematic, because that kind of destabilization makes us in the industry think differently about whether we’ll pursue different indications. No one wants to make a decision that’s not in the benefit of patients and public health. That’s one important element.

Another piece is that if you start to pull the thread of what this could mean, I’m very concerned about the potential fall-out. What happens when another state district judge, or another very galvanized or zealous third-party group decides that they don’t think a certain medicine should be available? This could happen to anything from HIV medication, mental health treatments, or other women’s health treatments. Apart from the politics, the precedent that this could create is very unsettling.

It's not just the reliability of the administration of the safety of medicines in our country, but more importantly, the access to medicines that are critical to people’s health. That’s extremely disconcerting and it’s happened very quickly. That’s fundamentally why I’m motivated on this because I see the bigger ripple effect that this could have. It could be extremely destabilizing.

PE: What is the importance of our regulatory system?
Alexander: We are the world leader in bio-medical innovation. Americans have access to medicines first. We have access to some of the best medicines. Does that mean that our policy can’t improve, or we don’t have a high bar to hit in terms of medical innovation? Of course we do, but that is a privilege for us to have.

If you don’t preserve and foster it, you can wake up one day and it might not be there. There are components of the IRA that we’ve learned that lesson the hard way (in terms of some of the orphan drug clauses, which we’ve risk mitigated against). I know bigger companies have been on the record saying that they’re not pursuing certain indications because they can’t do it in a way where they’re going to be effective as a business.

That’s a terrible outcome for patients.

It’s also important to our national security. Other countries are looking at what we’ve done here. They’ve looked at the experiments and the regulatory processes that we’ve built. They’re trying to emulate and outpace us. Instead of dismantling what’s working, they’re investing in what could be working and beyond. We’re seeing that in places like China with neuroscience.

The implications for our society are significant.

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