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.
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.
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.
CMOs and CDMOs may be less directly impacted by these enhancements than the ANDA filers are, but PBOA was glad to be part of the conversation throughout the process and to develop a better understanding of the bottlenecks in ANDA reviews, the dynamics between the generics industry and the FDA, and the ways in which facility inspections are changing under FDA's inspectorate overhaul and risk-based model.
As the new kids at the table, PBOA was treated respectfully by the other participants, and I believe that this experience, over and above the immediate changes to the GDUFA program, will help our sector work more closely with industry and FDA.
I assured the panel that PBOA and its Quality Technical Group would submit a comprehensive letter detailing our other concerns to the agency's docket.
When the meeting adjourned, I was approached by another trade association and asked if PBOA would like to join a cross-industry collaboration with such groups as APIC, BIO, BPTF, CHPA, GPhA, ISPE and PhRMA to formulate a docket letter that conveyed broader industry's concerns with the agency's approach to Quality Metrics.
In addition to advocating and representing its industry before regulatory, governmental, and legislative bodies, PBOA hopes to educate pharma and biopharma companies, the general public and other stakeholders on the value that CMOs/CDMOs bring to the development and manufacture of therapeutics.
Those founding members each nominated a member to our board of trustees, and the board has done a great job of getting the PBOA off the ground.
The PBOA will work collaboratively to advocate and represent its industry before regulatory, governmental, and legislative bodies; educate pharma and biopharma companies, the general public and other stakeholders on the value that CMOs/CDMOs bring to the development and manufacture of therapeutics; and advance common industry goals and interests through industry research, analysis and knowledge sharing.
The PBOA will ensure that their voice is heard, that they have a seat at the table, and that the industry can move forward and mature.
For now, I'll be working to build the PBOA
, recruiting members, developing a legislative/regulatory agenda and giving the CMO/CDMO sector a voice with FDA and Congress.