Watchdog group says “massive lobbying effort” by medical device industry threatens public healthBMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e1521 (Published 28 February 2012) Cite this as: BMJ 2012;344:e1521
A watchdog group says that the medical device industry has lavished millions of dollars on US politicians in a “massive lobbying effort” to promote legislation that will weaken oversight of the industry and endanger the public.
The charges were made on 15 February by Public Citizen, a non-profit watchdog organisation based in Washington, DC, during a Congressional hearing on the Medical Device User Fee Act. Consumer groups and industry representatives clashed during the hearing on the proposed legislation, which was hammered out after a year of negotiations between the industry and the Food and Drug Administration.
The current act will expire on 30 September. If the proposed legislation is adopted, fees paid by industry to the FDA will more than double from $287m (£180m; €215m) to $595m.
Public Citizen’s report says that the device industry spent $33m in lobbying in 2011, when 225 lobbyists—including 107 previously employed by the federal government—were employed to meet politicians about regulation of devices. According to the report the lobbyists sponsored “at least 40 fundraisers for members of Congress in 2011.”
Jeffery Shuren, director of the FDA’s Centers for Devices and Radiological Health, said in testimony to Congress that the higher fees, which are intended to speed up approval times and innovation, will “improve the predictability, consistency, and transparency of our pre-market programmes.”
Michael Carome, deputy director of Public Citizen’s health research group, told the BMJ that a key problem with the user fees is that they are “solely focused on pre-market review and not for post-market safety review.” He said, “Having more devices increases exposure to safety risk, and if the standards remain the same, or the bills weaken them, that would further undermine device safety.”
Public Citizen’s report cited a number of unsafe devices that it said should provoke the agency to tighten rather than loosen current regulatory oversight. Among the problems cited were “an implantable pad designed to shield breast tissue from radiation treatment that shreds small particles of tungsten into the breast; an infusion pump that shuts down unexpectedly or dispenses an incorrect dose of medicine; faulty defibrillators that inappropriately deliver severely painful and potentially dangerous electrical jolts to the heart; a surgical clip designed to clamp off arteries that pops off, causing patients to bleed to death internally; and an artificial hip that sheds metal fragments . . . causing extreme pain and limited mobility.”
In its report Public Citizen charges that a dozen other proposed bills will lower “already weak standards for clearing and approving medical devices”; loosen rules on conflicts of interest for FDA advisers; allow third party companies with financial ties to the device industry to review device applications; and prevent the FDA from disapproving any study method chosen by the industry to measure devices’ safety and efficacy.
Dr Carome told the BMJ, “Most people would be stunned to learn that, unlike drugs, many devices have never been proved to be safe or effective.” The watchdog group made a series of recommendations to improve oversight, including enhanced reporting of adverse events, requiring all moderate to high risk devices to undergo the same regulatory scrutiny as drugs, and restoring the right of patients injured by medical devices to sue manufacturers.
Responding to the safety concerns raised by Public Citizen, an FDA spokesperson, Karen Riley, told the BMJ, “The agreement reached by the FDA and industry for MDUFA [Medical Device User Fee Act] reauthorisation would facilitate device innovation and improve the timeliness of device approvals without lowering safety standards.”
Cite this as: BMJ 2012;344:e1521
Substantially Unsafe: Medical Devices Pose Great Threat to Patients; Safeguards Must be Strengthened, Not Weakened is at http://citizen.org/substantially-unsafe-medical-device-report.