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This article was originally published in The Gray Sheet

Executive Summary

HUMANITARIAN USE DEVICES REGULATION VIA PREMARKET APPROVAL instead of the investigational device exemption program should be implemented by FDA, Imre Corp. urges in Jan. 29 comments to FDA. Seattle-based Imre, which manufactures the Prosorba immunoadsorption device, submitted the comments in response to an agency proposal for humanitarian devices published in the Dec. 21 Federal Register ("The Gray Sheet" Dec. 21, p. 3). In the proposed rule, FDA said it plans to regulate the devices by waiving certain IDE requirements. Humanitarian use devices (HUDs) are those intended to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the U.S. Imre argues that, in writing the humanitarian use provisions of the Safe Medical Devices Act of 1990, "Congress intended to make a HUD available to the public...under the premarket approval provisions" of device law. The company points out that the SMDA refers to exemptions from performance standards and premarket approval requirements in discussing HUDs. In the proposed reg, FDA says it considered amending premarket approval regulations as a vehicle to bring humanitarian use devices to market more easily, but rejected the idea because the agency would have to write new PMA regs for institutional review board review and approval, patient informed consent, sponsor prohibition from making a profit on the device, and device distribution limitations to a period of 18 months (the length of a HUD exemption). However, Imre suggests that existing IRB review and approval and patient informed consent requirements could be modified and included in PMA regulations. The other two concerns raised by FDA "could also be managed relatively easily by revision of the PMA regulations," Imre says. Imre also claims that IDE requirements are an inappropriate mechanism for regulation of HUDs because they "will not carry out the Congressional intent of making humanitarian use devices available to the limited target patient populations." The company explains that "promotion of a HUD is prohibited under the IDE regulations." Without such promotion, "patients for whom the HUD is intended and health care professionals who would treat these patients will not be aware of the availability" of a HUD. Imre adds that FDA announcement of the availability of HUDs, which is discussed in the proposed rule, "would not provide sufficient notice to the general public or health care professionals." Regulation of HUDs through the IDE process also would be overly burdensome to manufacturers, Imre argues. "The expenditure of time and resources of a company with a HUD would be increased by the necessity of identifying and corresponding with potential investigators, entering into an agreement with each investigator, monitoring each investigation site, and fulfilling other IDE requirements. This would be an additional disincentive for a company to develop or distribute a HUD." The National Organization for Rare Disorders, which was influential in the creation of legislation to encourage development of drugs for rare diseases, also argues that the IDE program is inappropriate for humanitarian use devices and contrary to Congressional intent. The proposed rules "give nothing more to manufacturers of orphan devices than they give to other manufacturers," NORD asserts in Jan. 28 comments to FDA. In fact, "there is more work involved with no benefit to the sponsor because the manufacturer is required to reapply every eighteen months, which is not required for other IDE holders." The group urges FDA to "redesign the regulations to reflect the law's intent" of providing an easier route to market. "The regulations should specifically address premarket approval requirements and how to get a product to the market quickly and less expensively than ordinary devices with large potential markets," NORD states. "Smaller studies and less paperwork would be two important incentives that would make orphan devices available to rare disease patients more rapidly."

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