The Generic Drug User Fee Amendments were a key focus for PBOA in 2022. What has your progress looked like?

A core focus of ours in 2022 was helping shepherd the GDUFA 5-year reauthorization along. It was a little bumpy for a variety of reasons not tied to our negotiations, so the user fees — Generic, Prescription, Biosimilars and Medical Device — got approved later than they usually do in the fiscal year. Because of that delay, some FDA-related riders intended for the UFA legislation “fell out”, but some were included in the year-end Appropriations Omnibus bill. One of these was a pilot program for FDA to review advanced manufacturing platforms and technologies, in a way that’s not tied to specific drug applications, making them “application-agnostic”. We believe that will help free up resources on the FDA side over time as CDMOs’ platforms are better understood by the agency, helping those technologies proliferate.

What have been your Supply Chain Task Force’s main achievements?

That PBOA subgroup has connected with several agencies to discuss supply chain issues. We help when the HHS and other groups want to discuss how to ensure that supply chains are ready for the next pandemic. A key area is educating stakeholders about what “manufacturing” means, whether you’re talking about dosage forms or APIs, large molecules or small, excipients, or otherwise. For some areas, there is plenty of capacity in the US, and we help explain why investments and incentives need to be targeted, it is about getting sources of discrete doses and finding that balance. When it comes to “onshoring”, we help explain that “everyone has a shore”, and that a robust supply chain is better than a geographically constrained one.

To what extent do you expect a reshoring of the supply chain, and how does one close the manufacturing loop in the US?

It would take decades and add a huge cost to drugs to “reshore” the supply chain. In 2020, the previous administration put out an Essential Medicines List, the idea being to make sure these medicines have a secure supply chain. The new administration looks more towards “friend-shoring”, while still pushing for more domestic manufacturing. But friends are not immune to natural disasters. Italy is not an enemy of the US, but early in the pandemic, several API suppliers were not able to ship. As far as onshoring goes, we have explained that within the dosage form space, there is plenty of manufacturing capacity and room for expansion in the US.

How is the current geopolitical uncertainty impacting the life sciences industry?

The Ukraine crisis highlighted how Europe needs to look at its energy supply and how it will make sure they have secure supply chains. Part of that has involved the US more closely. With China, it is cloudy: we see changes in the country’s internal COVID positioning, and how they changed from a lockdown to a wide-open policy. Geopolitics will have a more significant impact going forward.

What are some of the key drivers of the CDMO market?

The growth in biologics, vaccines and cell and gene space are huge drivers. Also, more companies became more conformable with some type of outsourcing. J&J manufactured its bulk COVID vaccine but outsourced drug products to several of our members. They were comfortable with not owning that huge project, and never said, “We’ll work with these CDMOs until we can build our fill-finish capacity.” Smaller biotechs were getting more funding, which feeds into the CDMO sector, although that has dipped in the current interest landscape. The healthier the bio-startup world is, the healthier the CDMO market will be.

What will be PBOA’s main priorities heading into 2023?

Keeping an eye on where the onshoring conversations go. With the new Congress in place, there may be tensions in terms of pandemic preparedness and how much the government is willing to spend to sustain manufacturing capacity. On the regulatory front, the FDA continues working on its Quality Management Maturity Initiative, and there are challenges regarding the data they want to collect and how they plan to use it.