Legislating separate user fees for combination products could be debated when device or drug user fee programs come up for reauthorization.

In the meantime, gathering information about combo product applications will be key, Genzyme Senior VP-Regulatory Affairs Alison Lawton told participants at a recent Regulatory Affairs Professionals Society meeting in Baltimore.

FDA's "centers should be informing the Office of Combination Products [about] all of the applications that they receive, and...we should be collecting information about the resources needed for review and the review performance data...to help us understand whether in the future...the issue about fees for combination products should be addressed in some of the reauthorization bills," Lawton commented.

Both the device and drug user fee programs will be up for reauthorization after FY 2007. The industry rep suggested that such legislation would be "probably five or more years from now."

Other meeting participants agreed that the near-term focus should be on tweaking the current system to see if it is viable, before considering major legislative changes. Johnson & Johnson VP-Regulatory Affairs Robert O'Holla, for instance, advised industry to work to "fine-tune" the system, rather than seek an overhaul.

Regarding the possibility of a unique application for combo products, Office of Combination Products Director Mark Kramer remarked: "I think that there is some thought that it would be nice to have a combination product application type, and maybe that will turn out to be a good idea, but I still don't think, in and of itself, it will necessarily solve all of our issues."

"These products are very diverse. They range from pre-filled syringes to very complicated products that maybe we haven't even thought of yet, and therefore, I think the regulatory approach needs to be tailored to some extent, just as we do now with drug or device regulation," the OCP chief explained.

He stressed that "one size doesn't fit all," a theme many other participants echoed while debating potential regulatory reforms at the Jan. 11-12 combination products summit (¹ Also see "Combo Product Summit Generates Dialogue On Potential Reg Reforms" - Medtech Insight, 24 January, 2005., p. 7).

The meeting emerged from discussions between RAPS and a cross-industry group called the Combination Products Coalition.

CPC was among industry stakeholders that submitted comments on an OCP draft guidance on combo product user fees released last September (² Also see "Combo Products Typically Would Require Only One User Fee Payment – FDA" - Medtech Insight, 27 September, 2004. , p. 3).

In November comments to FDA, CPC wrote that "the user fee guidance would be strengthened by ensuring that the guidance better accommodates the tremendous diversity and novelty of combination products."

According to CPC, the document "struggles with the challenges raised by separate products packaged together as 'kits' and products not packaged as a unit, but required to be used together to achieve the intended use, indication or effect."

Several stakeholders in addition to CPC, which includes device, drug and biologics firms, were unclear as to when combo products with dual applications would qualify for fee waivers.

In the draft guidance, FDA maintained that "review of two applications when one would suffice places extra burden on FDA review resources."

Regardless whether industry or FDA decides that a product needs dual applications, the agency said it would require two fees if two applications are submitted.

The guidance noted that FDA "intends to look closely at whether a [Prescription Drug User Fee Act] 'barrier to innovation' waiver may be appropriate to reduce the additional fee burden associated with FDA's requirement for two marketing applications."

"We urge FDA to open access to waivers for all multiple-application submissions of combination products, regardless of who determines that more than one application is needed," CPC states in its comments.

CPC and PhRMA also request that FDA loosen its Innovative Combination Product Waiver criteria. "Not all innovative combination products are designed to offer clinical benefit," PhRMA contends. "Instead, they may be designed to offer other significant benefits such as economics, convenience or usability."

In separate comments, Medtronic also targets language in the guidance explaining criteria for the innovative combination product waiver. The device firm believes the current wording "could be an obstacle to legitimate fee waiver requests" in situations where "drug-delivery devices may be labeled for delivery of more than one drug."

Cook Group, meanwhile, contends that "reduction of drug fees should be considered even when only one application and fee is involved for an innovative combination product."

Cook urges FDA to update its 1993 draft guidance, "Interim Guidance Document for Waivers and Reduction in User Fees," to reflect device user fee legislation and combination product concerns.

"Drug establishment and product fees should be presumptively waived for a device firm that begins manufacturing a combination product containing device and drug constituents that is regulated as a drug, if the drug component is not made by the device firm," Cook argues.

The device company contends: "In this instance, requiring establishment and product fees would unnecessarily tax a device firm with no product and no drug manufacturing capability in a manner exceeding the fee responsibilities that Congress intended for device firms."

"This is particularly true where a drug used in a combination is already marketed and an establishment and product fee are paid by the drug manufacturer," Cook adds.

Medtronic also addresses drug/device combo products in its comments to FDA. "Where one agency component performs the majority of the data review, we propose that the application fee for the secondary application...be significantly reduced to reflect the amount of resources expended for the secondary application," the device firm states.

During the combo products summit, Kramer noted that guidance recommending when to submit one application versus two is close to being issued.

Kramer also said OCP's efforts to electronically track review consultations are near fruition. "We...have developed and are piloting an automated consultation system."

The IT system "is going to provide for a very nice system to track...the whole lifecycle of a consult...and will certainly help relieve our office of a lot of the manual work that is associated right now with our monitoring of consultations," he added.

Combo Products User Fees: Industry Comments On FDA Guidance, Eyes Future

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