Gil Roth, Pharma & Biopharma Outsourcing Association09.06.17
It was around 6 p.m. on Friday, August 18 when I got word that the White House had signed H.R. 2430, the FDA Reauthorization Act (FDARA), into law. FDARA reauthorizes several major FDA user fees for new five-year periods (FY2018-22), including the Generic Drug User Fee Amendments (GDUFA). Fittingly, the news came out via Twitter, albeit not from the President’s account.
As I scrolled through the @pboassoc timeline and read more statements about the signing, I flashed back on some of the milestones that brought us here: the afternoon in 2015 when our FDA contact e-mailed to say PBOA would be included in GDUFA II negotiations, the first negotiating session that October, the first time I blew my top (later that same month), the Saturday night in August 2016 when I “cracked the code” on a new fee model for the program, the ratification vote we held a few days later, the House and Senate subcommittee briefing visits after the election, and even back to the article I wrote for Contract Pharma back in 2013 that started this whole odyssey.
Schoolhouse Rock’s “I’m Just a Bill” cartoon prepared me for a long wait, but I will admit that I grew a little impatient during the 366-day span from industry ratification of GDUFA II to FDARA’s enactment into law. Still, it turned out to be time well spent, as our lobbying efforts on the Hill put PBOA and our constituents on the radar.
PBOA worked within the legislative process to protect GDUFA’s provisions from wayward amendments, holding numerous meetings with key congressional staff to explain GDUFA II’s new provisions, the funding model, and how the revised GDUFA program will help FDA and industry achieve the shared goal of improving review times and bringing more generic drugs to market faster. We were shepherded by our Washington, DC-based advocacy firm, whose staff learned our unique set of interests, lined up the right meetings for us, and kept us apprised of the key steps in the process of bringing FDARA to fruition.
From a CMO/CDMO perspective, our work on GDUFA II established a funding structure that reduces the user fee burden on CMOs and on manufacturing facilities overall: the CMO finished dosage form (FDF) Facility Fee will drop from $258,646 in FY17 to $70,362 in FY18 (non-CMO FDF facilities will pay $211,087), even as the overall GDUFA budget grows by 53%.
Just as important, the work we did on GDUFA established PBOA as the key resource for FDA and Congress when it comes to CMO/CDMO issues. We’ve made strong contributions to discussions on DSCSA/serialization implementation, the FDA’s Quality Metrics initiative, and the proposed OTC Monograph User Fee (OMUFA). The latter makes some of the same facility fee-derived mistakes of GDUFA I; in its initial proposal, 100% of the budget is derived from facility fees, with no carveout or exemptions for CMOs. We’ve argued to Congress that this model is regressive and may drive CMOs out of that manufacturing space, and they’ve listened, bringing us in for meetings to discuss our issues with the proposed funding model and our ideas for a fairer, more equitable structure. That sort of conversation is invaluable, and it didn’t exist for us as an industry a few short years ago.
As we move past FDARA (until the next reauthorization cycle), PBOA is in a position to advance a more proactive agenda, bringing together the voices of the CMO/CDMO sector to develop ideas that can strengthen our industry, improve quality, and bring effective medicines to patients. We’ll be discussing our future agenda during our first annual PBOA Meeting & Conference, a members-only event held October 3-4, 2017 in Rockville, MD.
PBOA isn’t PhRMA- or BIO-sized, but we do manage to punch above our weight, and that’s a testament to the critical role that our members play in the healthcare system.
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.
As I scrolled through the @pboassoc timeline and read more statements about the signing, I flashed back on some of the milestones that brought us here: the afternoon in 2015 when our FDA contact e-mailed to say PBOA would be included in GDUFA II negotiations, the first negotiating session that October, the first time I blew my top (later that same month), the Saturday night in August 2016 when I “cracked the code” on a new fee model for the program, the ratification vote we held a few days later, the House and Senate subcommittee briefing visits after the election, and even back to the article I wrote for Contract Pharma back in 2013 that started this whole odyssey.
Schoolhouse Rock’s “I’m Just a Bill” cartoon prepared me for a long wait, but I will admit that I grew a little impatient during the 366-day span from industry ratification of GDUFA II to FDARA’s enactment into law. Still, it turned out to be time well spent, as our lobbying efforts on the Hill put PBOA and our constituents on the radar.
PBOA worked within the legislative process to protect GDUFA’s provisions from wayward amendments, holding numerous meetings with key congressional staff to explain GDUFA II’s new provisions, the funding model, and how the revised GDUFA program will help FDA and industry achieve the shared goal of improving review times and bringing more generic drugs to market faster. We were shepherded by our Washington, DC-based advocacy firm, whose staff learned our unique set of interests, lined up the right meetings for us, and kept us apprised of the key steps in the process of bringing FDARA to fruition.
From a CMO/CDMO perspective, our work on GDUFA II established a funding structure that reduces the user fee burden on CMOs and on manufacturing facilities overall: the CMO finished dosage form (FDF) Facility Fee will drop from $258,646 in FY17 to $70,362 in FY18 (non-CMO FDF facilities will pay $211,087), even as the overall GDUFA budget grows by 53%.
Just as important, the work we did on GDUFA established PBOA as the key resource for FDA and Congress when it comes to CMO/CDMO issues. We’ve made strong contributions to discussions on DSCSA/serialization implementation, the FDA’s Quality Metrics initiative, and the proposed OTC Monograph User Fee (OMUFA). The latter makes some of the same facility fee-derived mistakes of GDUFA I; in its initial proposal, 100% of the budget is derived from facility fees, with no carveout or exemptions for CMOs. We’ve argued to Congress that this model is regressive and may drive CMOs out of that manufacturing space, and they’ve listened, bringing us in for meetings to discuss our issues with the proposed funding model and our ideas for a fairer, more equitable structure. That sort of conversation is invaluable, and it didn’t exist for us as an industry a few short years ago.
As we move past FDARA (until the next reauthorization cycle), PBOA is in a position to advance a more proactive agenda, bringing together the voices of the CMO/CDMO sector to develop ideas that can strengthen our industry, improve quality, and bring effective medicines to patients. We’ll be discussing our future agenda during our first annual PBOA Meeting & Conference, a members-only event held October 3-4, 2017 in Rockville, MD.
PBOA isn’t PhRMA- or BIO-sized, but we do manage to punch above our weight, and that’s a testament to the critical role that our members play in the healthcare system.
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.
