I mentioned the proposed Over The Counter Monograph reform act, and its associated user fee, OMUFA, at the close of my previous column in this magazine.¹ At the time, I was concerned about the proposed user fee, which relied 100% on facility fees. I’m glad to say that the Pharma & Biopharma Outsourcing Association (PBOA) was able to work with Congress, FDA and industry stakeholders to work out a fairer facility fee model, including a reduction for CMO facilities.

As I also mentioned in that column, coming up with an agreement between industry and FDA isn’t the end of the process for user fees. Congress has to enact them into law, so it’s important that industry visit pertinent House and Senate offices to explain what’s in the user fee package and why it’s there.

Last month, I visited several Congressional offices to talk about PBOA’s support for OMUFA and its goals, and our satisfaction with the new fee model. I usually start off Congressional staff visits by providing background about the role of the CMO/CDMO sector in healthcare, the economic impact our domestic members have, and a brief history of the PBOA.

This all tends to be eye-opening to my hosts, because our sector has been such a well-kept secret all these years. The questions they ask me show that they see us as a new resource and perspective on a wide range of issues. (Lest I get hauled into the wrong hearing, I always make sure to tell them, “We have nothing to do with setting drug prices!”)

In two meetings that day, the conversation shifted from OMUFA to another area: the opioid epidemic. I wasn’t expecting to talk about that subject, but I was ready to explain how some of our member companies are working on abuse-deterrent formulation technology. It turned out they were concerned about a more basic aspect of the problem: the packaging.
One staffer wanted to learn more about whether the Drug Supply Chain Security Act (DSCSA), and its promise of serialization/track & trace capabilities for drug products, could help combat diversion of and trafficking in opioids.

I spent some time explaining how PBOA’s Serialization Working Group has been engaged with FDA and other industry stakeholders—their clients, as well as wholesalers, distributors, dispensers and pharmacies—on DSCSA implementation. Also, since the final stage of track & trace—“interoperable, electronic tracing of product at the package level”—won’t go into effect until 2023, I noted that Congress will need to find other ways of tackling opioid diversion in the interim.

Another healthcare staffer wanted to hear from me about the FDA commissioner’s recent comments that the agency may require immediate release formulations of opioids to be packaged in unit-dose blister packs. Would that be feasible?

Blister packaging? But I came here to talk about OMUFA, and maybe how CDMOs enable startups to advance their molecules.

I found myself having to reach back to years of contract packaging articles I wrote for this very magazine, trying to recall the first time I’d typed the words, “While more prevalent in Europe, blister packaging will become more widely accepted in the U.S. within a few years, experts contend.” Since I’d yet to receive a single prescription in anything but a pill bottle in the last five years, I felt confident telling her that blister packaging still had a way to go as far as wide acceptance in the U.S.

I added that CMOs (and CPOs) can’t make the investment in blister lines without commitment from clients, and that there may be more complicating factors in adoption to blisters: the increase in cost for the blister, package and carton; the space they would take up at a pharmacy (as opposed to bottles of pills); the DSCSA, as any new blister packaging capacity would have to include serialization capability, and that such equipment is already in high demand.

Part of my job is figuring out how CMO/CDMOs can help solve problems. I was disappointed to be a wet blanket at both of those meetings, but I’m looking forward to bringing our members together with policy-makers to find new solutions. 

References

1. Roth, G. (2017, September). FDARA and Beyond. Contract Pharma.

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Gil Roth
President, Pharma & Biopharma Outsourcing Association

Gil Roth is the President of the Pharma & Biopharma Outsourcing Association (www.pharma-bio.org). He can be reached at gil.roth@pharma-bio.org.