Re: 11/25/02 Public Hearing on Combination Products (Docket No. 02N-0445)
King & Spalding represents various manufacturers of combination products and would like to participate in the above-referenced meeting. We respectfully request that the following individual be included among the list of attendees and participants:
King & Spalding
1730 Pennsylvania Ave., NW
Washington, DC 20006
Ms. Whitesides requests 5-10 minutes to make a brief oral presentation regarding the following questions posed by FDA in its notice of the above-referenced public meeting (67 Fed. Reg. 65801 (Oct. 28, 2002)):
Discussion question (2): What factors should FDA consider in determining the primary mode of action of a combination product? In instances where the primary mode of action of the combination cannot be determined with certainty, what other factors should the agency consider in assigning primary jurisdiction:
Discussion question (4): Recognizing the need to ensure product safety and effectiveness, what criteria should FDA use to determine whether a single application or separate applications for the individual components would be most appropriate for regulation of a combination product?
In response to both questions referenced above, King & Spalding submits that FDA must be guided by a combination product's intended use and agency precedent in the regulation of substantially similar products with identical intended uses when determining a combination product's primary mode of action, the assignment of primary jurisdiction, and the requirement of a single versus separate premarket applications for the combination product's components. As FDA's notice of public meeting recognizes, the Federal Food, Drug, and Cosmetic Act ("FDCA") requires that FDA assign primary jurisdiction for a combination product based on the product's primary mode of action. As the agency's notice further recognizes, the term "primary mode of action" is not defined in the FDCA or FDA's regulations. In the absence of a clear definition, the agency is not always consistent in determining the primary mode of action and assigning primary jurisdiction for substantially similar products with the same intended uses. In some cases, FDA is also inconsistent in requiring only one premarket approval application for certain combination products while requiring multiple applications for functionally similar products within the same class. As FDA's report entitled "Regulation of Combination Products: FDA Employee Perspectives" (Oct. 2002) summarizes, "[T]he review jurisdiction for different products within a given class may be split between two Centers, leading to differences in the application of premarket regulatory authorities, review policies, postmarket regulatory controls, and other factors relevant to product regulation. …Interview participants reported that jurisdictional decision making sometimes appears to be arbitrary, and that class-wide jurisdictional assignments should be made whenever possible."
King & Spalding agrees that class-wide jurisdictional assignments should be made whenever possible. In particular, we believe that regulating substantially similar combination products with the same intended use in the same manner would promote much-needed consistency in regulatory treatment. Such consistency is not only desirable because it would result in greater equity, transparency, and certainty in regulation, benefiting both industry and FDA, but it is also legally mandated. As the District Court for the District of Columbia has admonished, "[Where different] products all likely meet both the definition of a drug and the definition of a device under the [FDCA],…the FDA…has discretion in determining how to treat them. What the FDA is not free to do, however, is to treat them dissimilarly and to permit two sets of similar products to run down two separate tracks, one more treacherous than the other, for no apparent reason. …The disparate treatment of functionally indistinguishable products is the essence of the meaning of arbitrary and capricious [under the Administrative Procedure Act]." Bracco Diagnostics, Inc. v. Shalala, 963 F. Supp. 20, 28 (D.D.C. 1997) (emphasis added) (internal citations omitted) (holding that FDA may not regulate certain products through CDER when functionally similar products are regulated by CDRH). Thus, the court concluded with respect to premarket regulation that "the same tests and studies should be required of each [functionally identical] product before it is approved and that that result is impossible so long as the FDA treats one as a device subject to the regimen established by the CDRH and the other three as drugs subject to the more rigorous regimen established by the CDER." Id. In other words, similar products with the same intended uses should be subject to the same premarket testing and application requirements, including requirements for the submission of one premarket application or two. The same reasoning would hold with regard to the application of post-market requirements (e.g., QSR vs. cGMP requirements, MDR vs. drug adverse event reporting requirements, etc.).
The need for greater consistency in the regulation of substantially similar products with similar intended uses is not only called for by policy and case law, but also by legislative intent articulated in the Food and Drug Modernization Act of 1997 ("FDAMA"). In particular, in accordance with the "least burdensome" requirements established by FDAMA, FDA should not require the submission of two premarket applications for a combination product when only one application has been required for substantially similar products. The more burdensome requirement of a second application is contrary to Congressional intent and existing FDA guidance. Indeed, FDA's guidance entitled "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry" (Oct. 4, 2002) ("Guidance") makes clear that "[a] central purpose of [FDAMA] is to ensure the timely availability of safe and effective new products that will benefit the public and to ensure that our Nation continues to lead the world in new product innovation and development. …Congress' goal was to streamline the regulatory process (i.e., reduce burden) to improve patient access to breakthrough technologies." Guidance at 3 (internal quotations omitted). FDA has further clarified that "[t]he least burdensome concept should be integrated into all premarket activities" involving devices, including combination products with device components. Guidance at 4. In accordance with the least burdensome mandate, FDA should revise its regulatory approach to combination products to ensure that the least burdensome pre- (and post-) market authorities are applied, including imposing consistent requirements for the number and content of premarket applications requested for substantially similar combination products.
King & Spalding appreciates the opportunity to participate in the above-referenced public meeting. We look forward to confirmation of our attendance. Please do not hesitate to contact Ashley Whitesides (contact information provided above) if you should have any questions. Thank you.
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