FDA’s Authority in Question as it Re-Examines Knee Device Approval

The Food and Drug Administration is re-evaluating a device used in knee surgery that was approved in 2008. Although it is unclear whether the FDA has the authority to reverse its previous findings, the original approval process for this device was problematic.

According to the Wall Street Journal, the device, called Menaflex, was approved over objections from FDA scientists and managers. Menaflex’s makers, New Jersey-based ReGen, had lobbying help from four members of Congress. The FDA replaced scientists who objected to the device and fast-tracked the application. Critics of the FDA’s decision say re-evaluating approved devices will greatly slow the process.

The Wall Street Journal has stories on the inadequate data regarding the knee device’s safety, the FDA re-examining its previous approval and the Menaflex lobbying campaign.

Wednesday Briefing

May 16, 2012 |

Proposed Pennsylvania study could help resolve debate about whether natural gas drilling is making people sick. In recent years there have been lots of anecdotal reports about people who say they have been harmed by the chemicals associated with gas wells and the controversial drilling technique known as fracking. But “there doesn’t seem to be a lot of hard data to either support or refute those claims,” said a research official with the Geisinger Health System, which provides care to more than 2 million Pennsylvanians. So Geisinger officials are courting scientists and funding agencies to gain support to use their huge database of electronic health records to help researchers get answers. NPR

U.S. nuclear regulators overhaul community emergency planning. The changes by the Nuclear Regulatory Commission, made quietly, require fewer exercises to prepare for major accidents and call for fewer people to be immediately evacuated. The overhaul, the first since the planning program began after the 1979 Three Mile Island disaster, also eliminates a requirement that local responders always practice for a radiation release. The changes seem at odds with the lessons of last year’s nuclear crisis in Japan. One new exercise was added, providing for police to take part in exercises that prepare for a possible assault on local plants, but some emergency officials say it doesn’t go far enough. The Associated Press

Panel endorses home test for HIV. Experts advising the Food and Drug Administration unanimously recommended that the agency approve a mouth-swab test made by OraSure Technologies Inc. The test, a home version of one already sold to health care professionals, would be sold in retail stores so consumers don’t have to go to a medical office to be evaluated for the virus that causes AIDS. If the OraQuick test wins final approval, it would mark the first time that HIV test results could be obtained at home. Other home HIV tests require a fluid sample to be sent to a laboratory. Federal health officials estimate that about 20 percent of people with HIV don’t realize they are infected and risk spreading the virus. The Wall Street Journal, Reuters

U.S. asthma rate hits a record high. The proportion of Americans with asthma increased to 8.4 percent in 2010, from 7.3 percent in 2001, according to the U.S. Centers for Disease Control and Prevention. In 2010, an estimated 18.7 million adults and 7 million children had the disease. “It is the most common reason for children to miss school, and an important cause of missed work in adults. Although the mortality from the disease has been decreasing, [asthma] still causes over 3,000 deaths in this country a year,” one expert said. Asthma, one of the most common lifelong chronic diseases, causes wheezing, breathlessness, chest tightness and coughing. There is no known cure. HealthDay, Los Angeles Times

Settlement slaps restrictions on drug distributor. Cardinal Health, the second-largest U.S. drug distributor, will be barred from selling powerful painkillers from its Lakeland, Fla., operation for two years under the deal with federal authorities. The Drug Enforcement Administration had sought to revoke Cardinal’s license, accusing the company of selling excessive amounts of prescription painkillers to four Florida pharmacies. The DEA said the company did not report the suspicious orders. The agency said it still may pursue civil penalties against Cardinal. The government also continues to press its legal case against two CVS pharmacies in Sanford, Fla., that purchased millions of oxycodone pills from Cardinal. USA Today

Compiled by Stuart Silverstein

Tuesday Briefing

May 15, 2012 |

Study links up to 5 percent of road crashes to tire problems. A report by the National Highway Traffic Safety Administration found that underinflation -- meaning tires 25 percent below their rated pressure -- was the most common tire problem linked to crashes. A low tire reduces a vehicle’s stability even under ideal conditions, but it ...

FDA’s Authority in Question as it Re-Examines Knee Device Approval

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