The discussion centers on the affordability requirement tied to obtaining a Commissioner’s National Priority Voucher (CNPV)—a pilot program launched by the FDA to offer a faster review for drugs that tackle nationa health priorities. While affordability has drawn significant attention, Ed Schoonveld, value and access advisor for Schoonveld Advisory and author of The Price of Global Health, clarifies that it is just one of five possible eligibility criteria, which also include breakthrough innovation, addressing key public health challenges, and strengthening supply chain security. Manufacturers do not necessarily need to reduce drug prices to qualify, based on how the requirement is currently written.
He emphasizes that affordability should not be narrowly interpreted as lowering list prices. For therapies that treat high-burden diseases such as cardiovascular conditions, diabetes, or Alzheimer’s, manufacturers may demonstrate affordability through reductions in total healthcare expenditures. High-value therapies can offset costly downstream care, meaning affordability can be achieved by improving outcomes rather than discounting the treatment itself. A strategy of launching products with dramatically lower prices simply to meet voucher qualifications seems counterintuitive, especially when value has yet to be fully assessed.
Schoonveld raises concerns that the FDA appears to be moving into evaluations traditionally handled by health economists and payers, such as determining fair pricing or cost-effectiveness. In the US, authority over drug pricing has historically remained outside the FDA, recognizing that pricing decisions require different expertise and policy frameworks than scientific review.
Ultimately, he argues that the FDA should remain focused on its core responsibilities: ensuring the safety and efficacy of medical products. Affordability is an important societal issue, he acknowledges, but evaluating and regulating drug costs should remain the domain of payers and other agencies better equipped to manage economic policy.
He also shares CNPVs value given their non-transferability, offers a preview of his latest Pharma Commerce column; and much more.
A transcript of his conversation with PC can be found below.
PC: One requirement for receiving a CNPV is committing to improve affordability. Given the Trump administration’s push for MFN pricing, how should manufacturers think about balancing price-setting strategy with these expectations?
Schoonveld: First of all, when you look at the requirements for the voucher program, the affordability is just one of the requirements. It could be one or more of the five requirements that have to be met, so it doesn’t have to address affordability, at least not how it’s written up in the requirements. Kind of a breakthrough treatment, a public health issue addressing, supply chain security, and then affordability, so it doesn’t have to do that.
Also, when you’re looking at how affordability is described, it’s described as it could be a drug cost lowering, but it’s also talking about offsetting medical treatments’ total healthcare costs, so there are certainly opportunities for high-cost treatments or high-cost diseases like cardiovascular disease, diabetes, Alzheimer’s disease. There are plenty of opportunities to find other offsets without just making it the price cut. For a company to develop a drug and to then create a quick launch because of a price cut doesn’t intuitively make a lot of sense.
I mean, how are you going to judge even a price cut? I was going to price it a $5 million dollars, and now I’m going to price it only at $30,00—I mean, that’s very hard to judge, so I’m not sure how they will go about that. What’s concerning me a little bit is that it seems the FDA—either at their own initiative, but maybe because of the Trump administration—is encroaching in the price-setting cost evaluation domain. In Europe, we’ve seen the EMA (European regulatory agency) do that many times, but their individual countries don’t decree that the European organization is going to do that. While this one may not be that damaging, it could also be seen as a step for the FDA towards getting into that field.
I personally feel that the FDA should focus on the science and the safety, and leave the affordability, I mean, it is an important issue, but should lead that to agencies that are more competent to particularly address that, including obviously the payers themselves.
