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.
Full textThis 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 jour -- health care reform -- Bai predicts that Obama will be compelled to wade up to his neck in the messy details of the legislation because only his personal power will be enough to guide this behemoth through. This prediction, which has already begun to come true -- note the stories last week saying he’d be willing to consider taxing benefits -- could spell disaster for a different issue: climate change legislation.
Allow me to pause for just a moment, in fairness to the Obama team, to lament congressional gridlock, which has yet to be resolved by the Democratic leadership, especially in the Senate. Because Majority Leader Harry Reid (D-NV) is unwilling to play even the mildest hardball with his recalcitrant Republican opposition on even the smallest issue (see, e.g., closing Guantanamo), the “wisdom” has taken hold there that everything declared controversial by the minority will have its content decided by whoever holds the 60th available vote -- or put another way, the 41st least oppositional senator. Not only is Reid unwilling to allow actual talk-all-night filibusters to proceed on issues that would affirmatively help Democrats politically, he has managed to send the signal that his own members can act up at will. So, for example, Sen. Evan Bayh, a Midwestern moderate, is suggesting that the United States should not act on climate change until China steps up with reductions of its own.
Full textWhen President Obama launched his open government initiative on his first full day on the job, few assumed that the ambitious endeavor it contemplated would be easy. After all, lack of transparency and even active efforts to conceal information had become almost an inextricable feature of the federal government’s internal operations and decision-making—especially during the George W. Bush Administration. A recent series of developments confirms just how challenging the effort to achieve a more open government will be; fortunately, some of these developments also suggest that the Administration has learned some lessons from the initiatives’ early difficulties and perhaps is now moving in the right direction.
Obama launched the good ship “open government,” via a memorandum issued on January 21, laying out a vision of open government that was predicated on three pillars: transparency; public participation; and collaboration. The memo directed the Chief Technology Officer to work with the Director of the Office and Management Budget and the Administrator of General Services to develop a series of recommendations for an “Open Government Directive” that would direct executive agencies (including independent agencies) to take specific actions that are calculated to integrate the three pillars of open government into the agencies’ daily operations and decision-making procedures. The memo gave the Chief Technology Officer 120 days—that is, until May 21st—to achieve this task.
Full textIn 2007, the FDA came under criticism for failing to inform the public about studies it had had for two years which indicated that users of the diabetes drug Avandia faced up to a 42% greater chance of suffering a heart attack. More recently, it was revealed that Bush-era political appointees at the agency surreptitiously worked with chemical industry representatives to downplay evidence of the adverse health effects caused by bisphenol A (BPA), a chemical frequently used in making plastic toys and baby bottles. Thanks to scandals like these, the FDA has long been dogged by criticisms for the lack of transparency with which it conducts regulation.
The Obama Administration says it will be taking on the issue. The FDA announced Tuesday that it would be beginning a process to enhance “the transparency of the agency’s operations and decision-making process.”
Full textOn Tuesday, Representatives Henry Waxman and Bart Stupak sent a letter to FDA Commissioner Margaret Hamburg asking the agency to re-examine its assessment that bisphenol A (BPA) does not pose health risks to consumers. The FDA responded that it was already planning on doing so, and that a new decision would be released within "weeks, not months" (AP, Milwaukee Journal-Sentinel).
Full textThe Milwaukee Journal-Sentinel reported on Saturday, and the Washington Post on Sunday, about a meeting of industry groups in Washington last week to devise a plan to respond to criticisms of Bisphenol A (BPA).
From the Post:
Manufacturers of cans for beverages and foods and some of their biggest customers, including Coca-Cola, are trying to devise a public relations and lobbying strategy to block government bans of a controversial chemical used in the linings of metal cans and lids.
The Environmental Working Group has posted the full memo summarizing the meeting. The memo says that the commitee is focusing lobbying efforts on Connecticut and California, given pending legislation. And: "Their 'holy grail' spokesperson would be a 'pregnant young mother who would be willing to speak around the country about the benefits of BPA.' "
Serious health concerns ought to be treated as serious health concerns, not just a PR problem.
Full textThe Milwaukee Journal-Sentinel continued its impressive BPA reporting Sunday with disturbing revelations about former FDA political appointees' utter disregard for the agency's career scientists. Using the Freedom of Information Act, the Journal-Sentinel uncovered e-mails showing that high-level officials went to industry lobbyists for advice about new research on bisphenol A (BPA) before asking FDA career staff.
In one instance, the U.S. Food and Drug Administration's deputy director sought information from the BPA industry's chief lobbyist to discredit a Japanese study that found it caused miscarriages in workers who were exposed to it. This was before government scientists even had a chance to review the study.
"I'd like to get information together that our chemists could look at to determine if there are problems with that data in advance of possibly reviewing the study," Mitchell Cheeseman, deputy director of the FDA's center for food safety and applied nutrition, said in an e-mail seeking advice from Steven Hentges, executive director of the trade association's BPA group.
BPA is a chemical used to make clear and rigid plastics -- everything from water bottles to dental fillings to DVDs. Its ubiquity in commerce translates to pervasive levels of human exposure: it is found in the urine of 93 percent of Americans.
Full textOn Thursday, Rep. Raul Grijalva introduced HR 2192, a bill on adapting to the impacts of climate change. The law would establish a "Natural Resources Climate Change Adaptation Panel" that would create a plan for several federal agencies to anticipate and seek to mitigate the effects of a changed planet.
The bill is very similar to the natural resource adaptation provisions (Title IV, Subtitle E, Subpart C) in the Waxman-Markey draft climate change legislation. Those provisions were a good start, though certainly not perfect (Holly Doremus and I previously analyzed the good and the bad of those provisions here).
E&E News reported (subscription required) that Grijalva's bill, along with a separate one in the works in the House Science Committee, are "expected to be voted on before Memorial Day and eventually to be folded into [Waxman-Markey]." If it came to it, should Waxman-Markey stumble, this bill could go ahead separately.
Full textCPR Media Consultant Matt Freeman on the news that two Milwaukee Journal-Sentinal reporters have won a prestigious journalism award for their 2008 reporting on BPA and FDA's handling of it. Full text
Center for Progressive Reform Policy Analyst James Goodwin blogs on how past efforts to "improve" cost-benefit analysis has actually had the effect of tilting regulatory impact analysis so that regulations are less protective of vulnerable populations in the United States, including the elderly, the poor, and racial minorities. Full text