A bipartisan group of lawmakers introduced legislation aimed at clarifying the review process for combination products.
Sens. Johnny Isakson (R-Ga.), Robert Casey (D-Pa.), and Pat Roberts (R-Kan.) introduced the Combination Product Regulatory Fairness Act of 2015, which would amend language in the Federal Food, Drug and Cosmetic Act related to these products. Isakson says the bill “will eliminate the high level of uncertainty in approval standards that currently exist for innovative companies, both small and large, when deciding to invest in a new product.”
A key provision of the bill, introduced July 17, emphasizes that reviewers may rely on prior findings of safety and effectiveness for a drug product, as well as existing premarket approvals when evaluating a combination product.
Also included in the bill is a proposal for a combination product review plan, detailing the necessary clinical studies, timelines and potential risks for the product. Sponsors could request a pre-CPRP meeting with the FDA to discuss requirements and standards related to the review of product’s safety and effectiveness — or substantial equivalence, postmarket modification or good manufacturing practices.
The bill proposes a 60-day period for the agency to review and either accept or refuse a CPRP. If the agency declines to approve the CPRP, a meeting must take place within 30 days to discuss the level of evidence necessary to ensure a positive determination of safety and effectiveness or substantial equivalence.
In addition, the bill would require the FDA to issue final guidance within two years of enactment describing each center’s responsibilities in the review process for combination products. The guidance should detail how each center evaluates evidence development and review under a risk-based approach, dispute resolution, labeling, product usability assessments and human factors testing.
Industry welcomed the lawmakers’ efforts. “Combination products — whether device/drug, device/biologic or drug/biologic — represent some of the most innovative treatment options for American patients,” AdvaMed President and CEO Stephen Ubl said.
“Unfortunately, FDA’s process for determining which of its centers has primary responsibility for reviewing these products, as well as the actual review itself, often lacks predictability and efficiency, delaying patient access to these cutting-edge advancements.”
Earlier this year, the FDA released a 46-page draft guidance document intended to clarify a 2013 final rule specifying how combination product manufacturers should meet both device and drug quality regulations and implement streamlined quality systems ().