IOM Report Advises FDA, NIH To Spur Innovation For Rare Disease Devices
This article was originally published in The Gray Sheet
Executive Summary
FDA and NIH should consider options for stimulating high-priority device innovations to treat rare diseases, including the creation of NIH awards, R&D tax credits and "inducement" prizes, according to an Institute of Medicine report
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Regulatory News In Brief
Devices for rare diseases: 1AdvaMed and 2Medtronic say FDA device reviewers should take a page from the agency's orphan drugs program and allow makers of approved humanitarian-use devices to gain market exclusivity for a time, make a profit on the devices and obtain tax credits similar to those for orphan drugs. FDA should also be able to tailor the maximum patient population size for a humanitarian-use device, the groups said in Aug. 31 comments on regulation of products for rare diseases. Currently, humanitarian-use devices must be designed for conditions that affect fewer than 4,000 patients per year. Regulators should be allowed "to selectivity raise the cap for specific conditions when FDA determines the health of orphan or pediatric patients requires an increase ... based on medical, demographic and scientific information provided by a petitioner," AdvaMed writes. In June, FDA held a workshop on regulation of products to treat rare diseases (3"The Gray Sheet" July 5, 2010)
Sen. Franken Tasks GAO To Explore Incentives For Rare-Disease Devices
Sen. Al Franken, D-Minn., sent a 1letter to the Government Accountability Office July 21, requesting that the watchdog agency explore government incentives to spur development of medical devices to treat rare diseases
Regulatory News In Brief
Neuro/physical medicine device reg: Neurological and physical medicine manufacturers want extra time to comment on a proposed rule and draft guidance documents that would establish special controls for 11 device types and exempt six of the device types from 510(k) pre-market submission requirements, provided they follow the special controls (1"The Gray Sheet" April 5, 2010). Comments on FDA's April 5 proposals were due July 6, but DJO, Slendertone, Electrostim Medical Solutions Inc., and the Neurostimulation Device Alliance say they'll need "adequate time for careful consideration of the technical issues and the clinical implications of the proposed special controls." In June 2 comments, Titan Medical "vehemently" opposes easing regulation of transcutaneous electrical nerve stimulator (TENS) devices, arguing that the proposed new process could pose safety issues. Titan also raises the question of whether "less effective" devices allowed on the market will be reimbursed by payers under the same codes as 510(k) products. "How do payers differentiate between the two types?" the firm asks