Introduction
The Coalition of PET Drug Manufacturers is a not-for-profit organization dedicated to the advancement of scientific and regulatory principles associated with the manufacturing and distribution of safe and effective drugs for diagnostic imaging with positron emission tomography (PET). Coalition leadership is comprised of a board of volunteers who are committed to addressing important issues by developing a consensus response. Coalition members consists of academic and commercial manufacturers of PET drugs, as well as other stakeholders, associations, organizations with interests in PET drug manufacturing.
The purpose of the Coalition is to help PET drug manufacturers to gain and maintain US marketing authorizations for PET drugs, including compliance with good manufacturing practice regulations (21 CFR Part 212).
Since its beginning, the Coalition has been the leading provider of educational, scientific, and regulatory information about PET drug manufacturing. The Coalition was formed in 2010 at the behest of the FDA to consolidate academic and commercial stakeholders in the PET drug manufacturing community. The first goal of the Coalition was to assist PET drug manufacturers in completing new drug and abbreviated new drug applications (NDAs and ANDAs) that were required in the wake of the FDA Modernization Act of 1997. More recently, with the finalization of the PET good manufacturing practice (GMP) regulations under 21 CFR Part 212, the mission for the Coalition has focused on FDA inspections and maintaining NDAs and ANDAs.
Fundamentally, the Coalition provides an interface between the FDA and the PET manufacturing community to enable the development of scientifically sound and rational regulations and practices associated with the manufacture of PET drugs. This community consists of academic and commercial entities located at more than 150 manufacturing facilities across the US. It is widely acknowledged that PET drugs demand specific considerations to remain a safe and cost-effective diagnostic modality. The Coalition is the only organization dedicated to the interests of this unique drug manufacturing environment.
Despite its recent growth, the size of the PET drug market remains small with revenue for our entire field less than the 100th best-selling drug in the US. Yet, over the last few years we have experienced the increased scrutiny of FDA inspections and heard reports of further tightening of the PET drug manufacturing regulations. An important focal area is to ensure that regulatory changes remain consistent with the broad understanding that guided the creation of the PET GMP regulations in the first place.
As the PET drug manufacturing world has evolved from its origins of predominantly FDG production, we believed that the interests of PET drug manufacturers would be best served if the Coalition evolved into a 501(c)(6) trade association. A 2021 survey of academic, government and commercial PET drug manufacturers (50% response) indicated strong support (>90%) for this transition and their willingness to pay dues to fund the trade association. Consequently, as of December 3, 2021, the Coalition was incorporated and gained 501(c)(6) trade association status.
Why an Independent Coalition?
The Coalition provides an interface between the FDA and the PET manufacturing community to enable the development of scientifically sound and rational regulations and practices associated with the manufacture of PET drugs.
As FDA has evolved over the last 10 years, an independent entity will now be more effective in interfacing with the Agency.
This community consists of academic, government and commercial groups located at more than 150 manufacturing facilities across the US.
It is widely acknowledged that PET drugs demand specific considerations to remain a safe and cost-effective diagnostic modality.
The Coalition is the only organization dedicated to the interests of this unique drug manufacturing environment
Primary focus is on assisting community with FDA inspections.