Section 3038 of the 21st Century Cures Act applies Hatch-Waxman rules to certain drug-device combination products, addressing the regulatory pathway for devices that incorporate already approved drugs.
The Hatch-Waxman Act, named for Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.), was approved in 1984. It was designed to make it easier for generic drugs to enter the market by requiring manufacturers to submit an abbreviated new drug application and prove their drug’s bioequivalence to the original branded drug. This meant generic drug makers would not have to endure the laborious and costly process of clinical studies.
The new provision under the 21st Century Cures Act mandates that the sponsor of a combination product may be required to submit data and information regarding safety, effectiveness and substantial equivalence for the previously approved drug. The sponsor must also provide data that demonstrates any incremental risks or benefits posed by the combination product compared to the drug alone.
If the combination product has a device primary mode of action with a pre-approved drug, then the sponsor of the product has to submit a certification regarding any patent information for the listed drug and provide notice that the challenged patent is invalid, unenforceable or not infringed. If the patent owner launches a suit against the sponsor, the FDA’s approval of the 510(k) or PMA could be delayed for up to 30 months. After any litigation, clearance or approval may be granted and the combination product sponsor will decide whether or not to market its drug-device combination “at risk”.
The provisions also include information about exclusivity. Any exclusivity provided by the 2012 Generating Antibiotic Incentives Now Act can be used to prevent the use of the drug in a combination product, including the 5-year new chemical entity exclusivity, 3-year new clinical investigation exclusivity, and 7-year orphan drug exclusivity.
The Hatch-Waxman provisions apply only if the drug-device combination product is reviewed under the device provisions of the FDC Act and there is an approved drug component. If separate marketing applications are submitted for the device and the drug, the provisions can be avoided.
The changes will impact drugs and devices that are physically integrated or packaged together – the FDA’s premarket data requirements will only focus only on the unapproved device and the incremental effects of the combination product. However, combination products in which the device and approved drug are sold separately are not affected by the legislation.
Section 3038 also does not address combination products with a biological constituent already licensed under the Public Health Service Act.