Who Are the Winners and Losers With FDA's Priority Review Voucher Program?

Pharmaceutical Executive: Who are the winners and losers with FDA's Priority Review Voucher Program?
Ryan Conrad: Ultimately, the winners should be the patients who need these drugs. That’s assuming that the program works as it’s intended to. Getting drugs approved faster is always a good thing, assuming that it’s safe and effective. Broadly, that’s who the winners are.

A lot of the drugs given the vouchers were already-approved drugs for new indications. Expanding indications is helpful on the payer side as it allows them to cover the drugs for a wider range of treatments.

The losers would be if something goes wrong and drug gets approved that wouldn’t have been otherwise, but that’s pretty unlikely. The workload is an issue. FDA lost some folks this year. While it wasn’t reviewers, workload is always an issue and if these reviews are taking up a lot of time and effort from other reviews, that’s not a good thing. Ultimately, I don’t think there will be a lot of losers.

PE: What does the list of approved drugs reveal about FDA's Priority Review Voucher program?
Conrad: The five voucher statement from FDA’s initial announcement is interesting. They said no more than five and now they’re up to almost 15 drugs being included in the program. It’s an interesting bargaining chip. Most of the drugs included are already approved and looking for supplemental approvals.

Big companies have the network and portfolios, so they can offer drugs to TrumpRx that can be offered at a discount. Smaller companies with more innovative drugs lack the portfolio to offer price reductions on.

What is FDA looking for? Do they want innovative drugs from small companies? If so, the companies can’t offer much. If they want new indications for existing drugs from the big players, those companies can. It’s an interesting trade off, and the FDA did a bit of both.

The first batch was for drugs with smaller patient populations, and the second batch is for bigger drugs. They did it all, which is an interesting way to do it.

PE: How will FDA's Priority Review Program impact domestic manufacturing?
Conrad: A company is not going to de novo set up a new US-based manufacturing site just for this voucher. They cost billions of dollars and take years and years of planning. I assume that any announcements were already in the works prior to the vouchers even existing.

It gets back to big companies that were already planning to move manufacturing to the US have another bargaining chip they can use. Small companies manufacture wherever they can.

In general, domestic manufacturing seems like a reasonable priority given the complexities of supply chains. It’s a problem, and to get manufacturing to the US seems like a good thing.