Protect Consumer Justice » Food and Drug Administration

Lawmakers bid to close loopholes on malfunctioning med devices

eric — Wed, 08 Feb 2012 20:09:40 +0000

We have all heard the horror stories. Artificial hips that grind and pop inside the human body. Internal heart defibrillators meant to save lives that instead go haywire and cause harm. Organ pumps that end up performing like a reject fuel-injection system. Woven mesh surgical patches for mending bladder and other organ tears that end up failing.

But now a group of federal lawmakers are stepping up to take on medical device manufacturers and the Food and Drug Administration, the gatekeeper for deciding if such devices go on the market.

A report from Safety Research & Strategies Inc. details how four members of Congress are attempting to tighten the rules that were eased during the Bush Administration to allow medical devices on the market with far less strict review. Some types of devices can now make it to market with no clinical testing or proof of efficacy.

The legislation is being pushed by by Reps. Edward J. Markey (D-Mass.), Henry A. Waxman (D-Calif.) and Jan Schakowsky (D-Ill.), who all sit on the House Committee on Energy and Commerce’s Subcommittee on Oversight and Investigations.. A fourth sponsor, Rep. Rosa DeLauro (D-Conn.), is a member the appropriations committee’s Subcommittee on Agriculture, Rural Development, the FDA and related agencies.

Meanwhile, Consumers Union has stepped up its efforts to prod Washington to boost oversight. This week, Consumers Union’s Safe Patient Project is bringing eight patient safety activists from around the country to the Capitol to meet with lawmakers in a bid for improvements to the Medical Device User Fee Act (MDUFA). That act has been the subject of intense scrutiny as problems with various medical devices have continued to make headlines.

“Most Americans would be surprised to learn of the lax oversight of medical implants,” Lisa McGiffert, director of Consumers Union’s Safe Patient Project, said in a press release announcing the effort. “Too many of these devices are allowed on the market without testing to determine whether they are safe and effective. Innovation is important but patient safety should be our first priority. A medical device isn’t innovative if it doesn’t work and hurts people.”

Astonishingly, 90 percent of medical devices do not require proof that they have been clinically tested and found to be safe and effective prior to being cleared by the FDA for distribution or sale, according to Consumers Union. The group is also pushing for a better system to monitor and track devices on the market so problems can be quickly identified and patients alerted.

Among the most notable problems have been among patients who received metal-on-metal replacement hips or hip resurfacing treatments. The group US Drug Watchdog this week launched a campaign designed to identify every US citizen, who is the recipient of any type of metal on metal hip implant device since 2004.

A fact sheet on problems with medical device problems on Consumer Union’s web site also calls on changes so the FDA can to use its recall authority more effectively and for lawmakers to provide the agency with authority to require device makers to do long term post market studies, regardless of which process is used in the pre-market phase.

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Conflicts of interest reported for FDA panel that signed off on Yaz birth control drug

jg — Wed, 11 Jan 2012 18:32:48 +0000

Washington Monthly blog: Jeanne Lenzer and Keith Epstein report some members of a U.S. Food and Drug Administration committee of medical experts that looked into the potential dangers of the Bayer birth control pills Yaz and Yasmin had potential conflicts of interest. “[A]n investigation by the Washington Monthly and the British medical journal BMJ has found that at least four members of the committee have either done work for the drugs’ manufacturers or licensees or received research funding from them,” they wrote. “The FDA made none of those financial ties public.”

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FDA advisers recommend stronger warnings for Yaz, Yasmin birth control pills

jg — Fri, 09 Dec 2011 23:28:33 +0000

Washington Post: “A popular new generation of birth control pills should carry stronger warnings about the risks they pose of potentially life-threatening blood clots, federal advisers recommended,” according to Rob Stein. Members of two U.S. Food and Drug Administration committees voted that the current labels on Yaz and Yasmin, both products of Bayer, fail to provide adequate warning about the potential of blood clots. But the committees also voted that “the benefits of the pills in preventing unwanted pregnancies outweighed the risks,” Stein reports.

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Former FDA head says Bayer withheld data about Yasmin

jg — Mon, 05 Dec 2011 22:17:58 +0000

Bloomberg: Former U.S. Food and Drug Administration commissioner David Kessler says in court documents that pharmaceutical giant Bayer withheld information from the FDA that users of the company’s Yasmin birth control pills had increased reports of blood clots. Margaret Cronin Fisk and Jef Feeley report Kessler’s comments about Yasmin were part of expert testimony in a federal lawsuit against Bayer in Illinois. More than 10,000 lawsuits have been filed against Bayer stemming from injuries allegedly suffered by users of Yasmin and its sister product Yaz.

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Tainted wipes may have led to fatal infection

jg — Tue, 15 Feb 2011 23:59:38 +0000

MSNBC: “The parents of a 2-year-old Houston boy who died from a rare infection are suing makers of recalled alcohol prep products, claiming contaminated wipes and swabs transmitted bacteria that caused his fatal case of meningitis,” writes JoNel Aleccia. A little more than a month after Harrison Kothari‘s death, a relative found an online notice of the recall of alcohol swabs and wipes made by the Triad Group because they may have been contaminated with the same rare bacteria that led to Harrison’s death. Those wipes had been used in the hospital where Harrison was infected.

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Lack of testing leads to medical device recalls

jg — Tue, 15 Feb 2011 23:39:48 +0000

New York Times: A study published in The Archives of Internal Medicine found that “most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway that requires little, if any, testing,” reports Barry Meier. The devices include external heart defibrillators and mechanical ventilators. One of the authors of the study told Meier, “This is an area where the [U.S. Food and Drug Administration] has failed the public.”

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Makers of POM Wonderful sued for claiming health benefits

jg — Wed, 18 Aug 2010 18:16:35 +0000

Courthouse News Service: The makers of POM Wonderful pomegranate juice are accused of deceiving consumers by claiming their juice has “special health benefits,” using such slogans as “Cheat death.” Matt Reynolds reports on a class action lawsuit filed in Florida stemming from what the plaintiffs describe as an “extensive and comprehensive marketing campaign.”

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