Are medical devices effective and safe?
posted at 7/31/2011 10:39 AM EDT
Will the U.S. assure that medical devices are effective and safe before they are released for sale?
Since the Safe Medical Devices Act of 1990, the federal Food and Drug Administration (FDA) has been granting requests to allow high-risk devices (known as Class III) to receive expedited clearance for marketing, through the "510(k)" process for medium-risk devices (known as Class II). Direct evidence of effectiveness and safety is not required for medium-risk devices, and requirements for any clinical testing are at the discretion of FDA. Expedited clearances have been granted for several types of high-risk devices that later proved to be troublesome, including hip implants, knee implants and automated external defibrillators.
A notorious example was the Menaflex knee implant. FDA rejected applications for expedited clearance of the Menaflex device three times. Then, during the Walker Bush administration, former FDA commissioner Dr. Andrew von Eschenbach and his staff met repeatedly with four members of Congress--Sens. Frank R. Lautenberg and Robert Menendez and Reps. Steven R. Rothman and Frank Pallone, Jr.--who lobbied for the manufacturer and who had accepted campaign contributions from people associated with the manufacturer. Von Eschenbach ordered a rapid review by a special panel of advisers, allowing the manufacturer input on panel members. [ Gardiner Harris and David M. Halbfinger, FDA reveals it fell to a push by lawmakers, New York Times, September 25, 2009, at http://www.nytimes.com/2009/09/25/health/policy/25knee.html ]
After much strong criticism, the incoming Obama administration's FDA commissioner, Dr. Margaret A. Hamburg, rescinded clearance for the Menaflex device and fired Dr. Daniel Schultz, former director of the Center for Devices and Radiological Health, who had coordinated the clearance. A "preliminary report" revealed "multiple departures from processes, procedures and practices" in the clearance. The report said expedited clearance for devices, "as implemented, appears to perpetuate questionable review decisions" and recommended an independent analysis of the process. [ at http://www.fda.gov/downloads/NewsEvents/PublicHealthFocus/UCM183642.pdf ]
The Institute of Medicine was asked to perform the analysis and recently released a report on it. [ Dr. David R. Challoner, et al., Medical Devices and the Public's Health, National Academy Press, July 29, 2011, at http://www.nap.edu/catalog.php?record_id=13150 ] To the horror of medical device manufacturers, the report recommends replacing the expedited clearance process used for medium-risk devices. It also recommends a more effective process to monitor performance after devices have been sold and used.
Replacing the clearance process and requiring manufacturers to demonstrate effectiveness and safety for each new device and device change would require another act of Congress, unlikely at this time. FDA lacks the large number of expert personnel who would be needed. However, FDA previously indicated that it intends to require a full, "PMA" process for some defibrillator devices.
Re: Are medical devices effective and safe?
posted at 7/31/2011 6:04 PM EDT
Some devices that are very similar to ones already on the market would be unfairly subjected to additional scrutiny. FDA processes cost money and in some cases keep competing devices off the market and keep prices for those devices high. As usual there are multiple sides to an argument.
You may not be able to sue for damages
posted at 8/1/2011 10:05 AM EDT
Because of halting, scattershot efforts to regulate medical drugs and devices, the federal government has repeatedly faced issues of products already in use when standards or procedures were added or improved. The 1906 Pure Food and Drug Act did not regulate safety or effectiveness of medical drugs and did not regulate medical devices.
Crises followed the 1938 Food, Drug and Cosmetic Act, regulating drug safety, the 1962 Drug Efficacy Amendment act, regulating drug effectiveness, and the 1976 Medical Device Amendments act, regulating the safety and effectiveness of devices. All created legacies of unregulated but "grandfathered" products.
There are dozens of unregulated products still being sold that were being distributed before 1938. McGuff Compounding Pharmacy Services is a well known manufacturer of several. A lobbying organization called American College for Advancement in Medicine represents the manufacturers, who say they support "integrative medicine." For decades FDA has practiced "regulation rationing," throttling efforts to clear out the cobwebs according to an evolving and sometimes political sense of priorities.
Occasionally Congress gets involved. The ironically named 1990 Safe Medical Devices Act opened floodgates for high-risk devices to be approved through expedited clearance procedures, intended for medium-risk devices, by formalizing a process for that to occur. Applicants for expedited clearance can claim and often have claimed that their devices are equivalent to older devices whose safety and effectiveness were never actually proven.
Another provision of the 1990 act created, in effect, short-term monopolies for device manufacturers who use the full PMA (pre-market approval) process, intended for high-risk devices. It prevents manufacturers who try for expedited clearance from using information about effectiveness and safety in a PMA application for four years after approval.
An activist federal court enacted new law for medical device regulation. In Riegel v. Medtronic, 2008, the U.S. Supreme Court held tort claims pursued in state courts against medical device manufacturers to be preempted by federal law when devices at issue were approved through PMA, though not when they received expedited clearance. Congress has since considered but not yet passed an act to overturn Riegel v. Medtronic. If not overturned, the judicial law may creep into drug regulation and extend to devices claimed equivalent to PMA-approved devices.
Re: Are medical devices effective and safe?
posted at 9/4/2011 9:56 AM EDT