Senators have introduced a bill to streamline current FDA regulations for combination products. What does it entail?
Legislators this Congressional session have had no shortage of proposals intended to improve medical device innovation. See—among others—the "21st Century Cures Act," the "FDA Device Accountability Act," the "Protect Medical Innovation Act," and the "Innovation Act."
Now, a few senators want to reform the regulation of combination products.
As the name suggests, combination products consist of a combination of a device, drug, or biological product. In the past, there has been some confusion about how best to shepherd a combination product through the regulatory process. One main issue is the lack of expertise in other product classes. For instance, a company that primarily makes medical devices may not have an expert in drug regulation, which may make a drug-device combination product a daunting challenge.
The "Combination Product Regulatory Fairness Act of 2015," sponsored by Senators Johnny Isakson (R–GA), Robert Casey (D–PA), and Pat Roberts (R-KS), is intended to allow FDA to use previous safety and effectiveness data for the parts of the product. According to a press release from Isakson's office, "this legislation emphasizes the ability of manufacturers and the FDA to rely on existing safety and efficacy data to prevent a duplicative regulatory process from stalling products’ accessibility to patients."
The legislation also aims to fix the confusion over which FDA center will review the combination product. According to the release, the bill would designate a lead center to decide which product center (CDER, CBER, or CDRH) the combination product should fit into. Companies would also construct a "Combination Product Review Plan" with FDA, outlining the product's regulatory process, required studies, and risks.
"The Combination Product Regulatory Fairness Act of 2015 will eliminate the high level of uncertainty in approval standards that currently exists for innovative companies, both small and large, when deciding to invest in a new product," Sen. Isakson said in the release.
Medtech industry group AdvaMed likes the legislation. Stephen Ubl, president and CEO of AdvaMed, said in a press release, “Combination products—whether device/drug, device/biologic or drug/biologic—represent some of the most innovative treatment options for American patients. 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."
The bill comes at a time when it seems industry is already getting more clarity on combination products from FDA. Earlier this year, FDA published draft guidance for its final rule on current good manufacturing practice (CGMP) requirements for combination products. Experts were impressed with the level of detail in the draft guidance. In a February 2015 article, Jim Johnson, partner at Hogan Lovells, told MD+DI that the draft is a "step in the right direction as far as prescriptive guidance . . . that I hope to see more and more from the agency."
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