By Jof Enriquez,
Follow me on Twitter @jofenriq
The U.S. Food and Drugs Administration (FDA) announced the creation of a new body which will coordinate reviews and tackle issues surrounding combination products, which are products consisting of any combination of a medical device and/or a drug and/or a biologic.
The Combination Products Policy Council "will be a senior-level, agency-wide forum for discussing, resolving, and implementing product and policy issues", and "will have decisional authority on issues relating to combination products, cross-labeled products, and medical product classification," according to an FDA Voice blog post.
Manufacturers and sponsors of combination products must satisfy separate and different requirements, through FDA’s Center for Drug Evaluation and Research (CDER) for the drug component, and FDA's Center for Device and Radiological Health (CDRH) for the device component. Although FDA previously announced the current good manufacturing practice (cGMP) rule for combination products (21 CFR Part 4) and related guidance, confusion persists among device companies and pharmaceutical companies in pursuit of FDA approval.
The Combination Products Coalition (CPC), an industry group consulted by FDA, reports that 70 percent of innovators reported delays as the result of problems during combination product reviews. In addition, 50 to 85 percent of respondents stated that, when a combination product-related conflict arose with either CDRH or CDER, the center would communicate its position without offering scientific and regulatory support for its position.
Upon identifying problems inherent in reviews of combination products after stakeholder feedback, FDA implemented a series of steps to improve the system, but admitted there is still room for improvement.
In the blog post, FDA officials acknowledge that continuing "differences in statutory and regulatory requirements for different application types, including evidentiary standards, data requirements, and review limitations, make it challenging to coordinate reviews and ensure alignment and consistency in addressing issues across centers."
Thus, the need to create the Combination Products Policy Council, which will have a three-pronged mission to:
- Modernize the inter-center consultation process and related aspects of combination product and cross-labeled product review;
- Promote development of innovative, safe, and effective combination products and cross-labeled products; and
- Promote alignment in addressing challenging medical product classification issues.
The Council will be composed of representatives from relevant centers and offices, and will serve as a "communications hub" that will issue agency-wide and external communications, such as draft guidances, publications, and blog posts on policy decisions.
"We are confident that the Council’s efforts will ensure transparency and consistency in our approach to combination product policy development and implementation, ultimately helping to ensure that innovative combination products marketed to the American people are safe, effective, and appropriately labeled," states the blog post.
Novel technologies used in combination products have the potential to disrupt the medical field, and often become the focal point in the development stage, but navigating the murky regulatory environment could prove to be more important for medical device and pharmaceutical companies.
"The key challenges are less about the technology itself and more about the integration of two distinct worlds — pharma and medical device," David Amor, managing partner at compliance and regulatory consulting firm MEDgineering, Inc., told MDO in a recent interview. "Quality and regulatory requirements in each industry are slightly different, and often the biggest challenges emerge when companies aren’t aware that the constituent products of a combination product are also governed slightly differently."
Amor recommends that companies follow guidance in 21 CFR Part 4 and the FDA draft guidance Current Good Manufacturing Practice Requirements for Combination Products to successfully satisfy regulatory requirements. For the device portion of their of the combination product submission, he proposes a basic, qualitative DHF equation to guide drug and device makers.