About

What is the CPC?

A group of leading companies in the drug, device and biologics industries, the CPC works to improve the regulatory environment for combination products by developing and advocating policy positions on regulatory issues affecting combination products. The unique cross-industry membership of the CPC enables diverse thinking that leads to sound policies. This diversity distinguishes the CPC from other industry organizations.

Mission

The Coalition’s Mission is to improve the regulatory environment for combination products. To that end, the Coalition focuses on developing and advocating policy positions on issues affecting combination products.

Principles

With membership in the Coalition come certain rights and privileges. Among them is the right to have a say in all decisions made by, and activities undertaken by, the Coalition. Specifically:

  1. Membership control. The decisions and activities of the Coalition will be controlled by the members of the Coalition. No policy decisions will be made or activities undertaken without agreement of the Coalition.
  2. Operation by consensus. In most cases, we will seek unanimous agreement on decisions and activities to be undertaken by the Coalition. Any move to allow decision-making by majority rule will require agreement of the Coalition members.
  3. Diverse viewpoints. The Coalition is founded on the belief that development of sound policies on combination products requires the unique perspectives of each of the component areas: Drug, device and biologic. With that in mind, the Coalition includes a diverse group of member companies with diverse viewpoints. This diversity is encouraged, and is what differentiates the Coalition from other industry organizations.
  4. Meetings. The Coalition typically will meet by teleconference to discuss issues and business pending before it. When appropriate, the Coalition may meet in person at a convenient location. Every effort will be made to schedule meetings during times when the majority of Coalition members are available to participate. Notice of teleconferences and in-person meetings typically will be provided by e-mail. Between such teleconferences and meetings, the Coalition will conduct its business through e-mail and oral communications, unless the Coalition agrees otherwise.
  5. Coordination. Bradley Thompson will be responsible for coordinating all Epstein Baker & Green, PC and EBG Advisor services involved in representing the Coalition, including all communications with members of the Coalition.
  6. Leaving the Coalition. Any Coalition member is free to leave the Coalition at anytime, for any reason. If at any point your company decides to leave the Coalition simply let us know. Your company will not be billed for the following month, or from that point forward.

History

In 2002, FDA established an Office of Combination Products (OCP) as required by SEC. 204 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). Until that time, FDA had operated in a largely silo environment where the centers for drugs, biologics and medical devices operated very independently and with little coordination. Unfortunately, industry to was fairly silent in that any work done on combination products was done by a trade group for one particular type of therapeutic product, and combination products were simply an afterthought.

About that time, many in industry began to realize that the future of therapeutic interventions was not limited to narrow categories of medical devices and drugs and biological products.  True innovation, that opened up the doors to greatly enhanced therapeutic value, depended on combining those technical disciplines.  However, companies largely were also siloed, focusing on mainly one type of product.

The Combination Products Coalition was formed in 2003, to start breaking down those silos, and consider a more holistic vision of appropriate combination product regulation.  The goal was always to achieve balance, balance between innovation and public safety, and balance among importing the historical approaches of medical devices, pharmaceuticals and biological products.  The group was formed with very careful consideration of ensuring that all the different sectors of the combination product industry were represented in order to best ensure that balance.  In this way, the industry as a whole could offer unified input on policy issues being considered by the newly formed Office of Combination Products and FDA.

Over the years the coalition grew to the point where it started to include certain special areas of focus, particularly with regard to injector systems and companion diagnostics.  Today the coalition maintains its laser like focus on combination products, but works with many stakeholders at FDA from OCP to the three centers, Congress, and other policymaking arms of the government.