The Pharma & Biopharma Outsourcing Association (PBOA) was established in 2014 to advocate for CMOs and CDMOs before FDA, Congress, and the overall pharma sector. In recent years, the stakes have become too high for us to rely on piecemeal efforts and the goodwill of other industry players; without a collective voice, CMO/CDMOs run the risk of becoming collateral damage as new regulations and laws are passed.

This was certainly the case with the Generic Drug User Fee Amendments (GDUFA) of 2012, which created a set of Facility Fees that cost CMO/CDMOs tens of millions of dollars annually. Intended to improve the FDA’s review times for Abbreviated New Drug Applications (ANDAs) and allow for more generic drug competition, GDUFA had the unintended consequence of driving some CDMOs out of the generic space and keeping others from entering it.

The PBOA’s key accomplishment was getting a seat at the table for the negotiations for GDUFA’s five-year reauthorization. I can’t discuss the negotiations or their progress, but it’s been an eye-opening experience for me and our negotiating team.

One area that I can talk about is PBOA’s response to the FDA’s Request for Quality Metrics draft guidance. This draft guidance was years in the making, and involves the use of manufacturing and product data to enable FDA, in its words, “to help develop compliance and inspection policies and practices, such as risk-based inspection scheduling of drug manufacturers; to improve the Agency’s ability to predict, and therefore, possibly mitigate, future drug shortages; and to encourage the pharmaceutical industry to implement state-of-the-art, innovative quality management systems for pharmaceutical manufacturing.”

Groups like PDA, ISPE and Xavier Health worked with industry and FDA to develop pilot programs, but CDMOs had little involvement with these efforts. Once the draft guidance was issued in July 2015, however, PBOA  worked overtime to represent the CDMO perspective.

In a key passage, the draft guidance is unclear about the role of CDMOs within the Quality Metrics initiative. Would CDMO sites be regarded as Reporting Establishments — the facilities that would report quality data directly to FDA — or as Covered Establishments — passing their data on to their clients, who would then report to FDA? If CDMOs were counted as Reporting Establishments, the guidance would then make them responsible for collecting data from their clients’ other suppliers — contract labs, API suppliers, packagers — or risk being labeled out of compliance. In addition, CDMOs would be responsible for conveying product information without letting their clients see/interpret the data.

I asked senior vice presidents of Quality at two PBOA member companies, with 20 and 30 years of experience respectively, how they read the guidance vis-à-vis the role of CDMOs. They had diametrically opposed interpretations of that language.

The FDA scheduled a public meeting on the draft guidance for mid-August 2015, so I canvassed our membership and assembled a list of their concerns, including: Would reporting be product- or site-specific? Did FDA plan to push reporting timelines into a single calendar period, or keep existing APR/PQR timelines? Would FDA keep its “scorecard” of facility quality confidential and protected from Freedom of Information Act requests? And did the agency understand that Quality Metrics might create an incentive for CDMOs to avoid complex products or other projects that could cause “bad numbers”?

At the public meeting’s Open Comments portion, I asked the FDA’s panel exactly where CDMOs fit within the draft guidance. They assured me that, despite the ambiguous language, CDMOs weren’t intended to be caught up in a net; their clients would be the Reporting Establishments responsible for collecting Quality data and sending it to 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 (available at www.regulations.gov/#!documentDetail;D=FDA-2015-D-2537-0078).

We signed on, and our Quality Technical Group worked extensively with the consortium to provide the CDMO perspective. Our learnings from that process helped inform our own docket submission (available at http://www.regulations.gov/#!documentDetail;D=FDA-2015-D-2537-0076), while also bringing PBOA into the orbit of other key industry stakeholders.
The CMO/CDMO industry still has a way to go, but our involvement in areas such as GDUFA and Quality Metrics shows that PBOA is on the right track.

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.