While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the medical device industry. The testimony outlined a troubling picture.
GAO has been closely monitoring FDA’s medical device program for years. On Thursday, Marcia Crosse, the head of the government watchdog’s health care division, testified about three serious shortcomings in FDA’s work. To begin, FDA isn’t necessarily reviewing high-risk devices according to the most stringent premarket review processes, meaning the devices might reach the market without adequate review of their inherent dangers, putting patients at increased risk. That problem leads to the second flaw GAO identified – FDA is overwhelmed by the adverse event reports submitted to the agency. Manufacturers, doctors, patients, and hospitals all inform the agency when medical devices are linked to patient injuries, but the sheer volume of these reports is too great for FDA to review. Finally, Crosse testified about FDA’s poor record of inspections on medical device manufacturing facilities. (Check out the recent ProPublica/Chicago Tribune article that highlights the tragic consequences of insufficient inspections.)
Crosse’s testimony was based in large part on a January report from GAO that provided thoughtful suggestions for how FDA might improve its work. I hate to sound like a broken record, but there’s one more thing Congress could do to promote medical device safety – restore the traditional role of state common law as a complement to FDA’s work. Since the Supreme Court decided in Riegel v. Medtronic last year that the Medical Devices Safety Act preempts state common law, patients injured by dangerous medical devices have lost an avenue for seeking compensation for their injuries. Preemption is a dangerous policy, particularly when FDA doesn’t have the capacity to do the job it needs to.
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Matt Shudtz | June 22, 2009
While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the […]
Holly Doremus | June 19, 2009
Cross posted by permission from Legal Planet. Rick earlier posted about the 20th anniversary of the Exxon Valdez oil spill. This week, the Ninth Circuit may finally have brought the litigation that followed that spill to a close. You may recall that last year the U.S. Supreme Court heard Exxon’s challenge to the punitive damages […]
Ben Somberg | June 19, 2009
Andrew Freedman of washingtonpost.com’s Capital Weather Gang has a nifty catch: the Heartland Institute, the people cluttering up my newspaper this week with climate-change-denying ads, have officially changed tack on their lobbying policy. Back in March, the group told Freedman: “Our purpose is to bring scientists, economists, and policy experts together to address issues overlooked […]
Ben Somberg | June 18, 2009
Today CPR releases Reauthorizing the Chesapeake Bay Program: Exchanging Promises for Results (press release, full report). For years, the jurisdictions within the Chesapeake Bay watershed (the states and Washington D.C.) have essentially not faced consequences for failing to meet pollution-reduction targets. It’s not surprising that the Chesapeake Bay has languished. What the new CPR report […]
Alice Kaswan | June 17, 2009
The Waxman-Markey bill, in its current form, continues the nation’s wise respect for the complementary roles of the federal government and the states. By establishing a national cap and a national trading program, the bill would draw all states into the essential task of reducing greenhouse gas (GHG) emissions. But, like the federal environmental laws […]
Daniel Farber | June 16, 2009
The Congressional Budget Office recently issued its report on the Waxman-Markey bill. The Washington Times soon trumpeted: “CBO puts hefty price tag on emissions plan: Obama’s cap-and-trade system seen costing $846 billion.” This is quite misleading. Actually, the CBO report tells us virtually nothing about the economic costs of the bill or how much consumers […]
Yee Huang | June 15, 2009
It’s a frackin’ mess out there in the world of natural gas extraction – exploding houses and water wells, dying cattle, and curious rashes. The Subcommittee on Energy and Mineral Resources of the House Natural Resources Committee recently held a hearing to explore the risks of hydraulic fracturing, or fracing (sometimes spelled, “fracking”), which is […]
Rena Steinzor | June 12, 2009
This past Sunday’s New York Times Magazine had a terrific piece by Matt Bai on the Obama White House and how it is “taking” Capitol Hill, one battle at a time. After extolling the team of congressional insiders Obama has assembled, and emphasizing the importance of their attentiveness to key players on the issue du […]
Holly Doremus | June 12, 2009
This week, a subcommittee of the House Committee on Natural Resources held a hearing on the problem of waste pharmaceuticals ending up in the nation’s waterways. The issue sounds trivial – does Congress really need to spend its time worrying about people with a few left-over prescription pills flushing them down the toilet? The answer […]