FDA Releases Draft Guidance For Risks Included On Medicine Advertisements

The Wall Street Journal (2/6, Silverman, 5.67M) blog “Pharmalot” is reporting that the FDA has issued new draft guidance requesting that drugmakers refrain from including long lists of risks and concerns associated with drugs in favor of a mild summary in print ads and promotional materials. The summary would not have to include information about all side-effect or contraindication. In the draft guidance, the agency explained that not many consumers have the technical background needed to understand some of the information described in the warnings as they exist now. The intention of the summary is to focus on the broader risks and important information instead of an exhaustive list of every possible issue.

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NPR Reports On Workplace Injuries Suffered By Nurses

NPR’s “All Things Considered”(2/4, 1.58M) examined the dangers nurses face at work, noting that the Department of Labor’s Bureau of Labor Statistics (BLS) found that more than 35,000 nursing employees suffer back and other injuries at work each year. According to the BLS, “nursing assistants are injured more than any other occupation, followed by warehouse workers, truckers, stock clerks and registered nurses.” The piece notes how some hospitals are trying to reduce the risk. However, “David Michaels, the assistant secretary of Labor who heads the U.S. Occupational Safety and Health Administration,” said Congress and the courts have severely restricted OSHA’s ability “to require hospitals to protect nursing employees.”

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Senators Request FDA Investigate Dietary Supplements

According to The Hill (2/5, Wheeler, 224K) Senators are encouraging the FDA to launch a “nationwide investigation after four major retailers were accused of selling mislabeled and tainted dietary supplements in their New York stores” by the state’s Attorney General Eric Schneiderman. Sen. Dick Durbin (D-IL) said in a statement, “Today, Sen. [Richard] Blumenthal [D-CT] and I are calling on the FDA to…take steps to protect all American consumers from an industry shown to be selling products they know are at best, ineffective, and at worst, truly harmful.” Sen. Blumenthal said in a statement, “The apparent widespread sale of fraudulently-labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight.”
The need for increased oversight over dietary substances is substantiated by the fact that US consumers “are nuts” for products they believe help them “boost their health and lose weight,” despite a “series of studies and investigations that have cast serious doubt on the safety and reliability of” dietary supplements, the Washington Post (2/5, Millman, 5.17M) “Wonkblog” reported. The popularity of dietary supplements is maintained by the “common public misperception that these products face the same rigorous oversight that pharmaceuticals receive from the FDA.” A report from the HHS Inspector General in 2012 “found that 20 percent of the weight loss and immune system support supplements they purchased made illegal claims about their ability to treat and cure disease,” and just a year later, researchers from Harvard “found that between 2004 and 2012, there were 237 recalls of dietary supplements — accounting for more than half of FDA recalls of Class 1 drugs,” which signifies that “the products contain substances that can cause death or serious health problems.”

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The Deadline For Filing Claims Regarding GM Faulty Ignition Switches Passed On March 31, 2015

The AP (2/3, Krisher) is reporting that “the families of 51 people who died in crashes caused by faulty” GM ignition switches will receive money from the GM compensation fund, with another 77 to receive money for injuries, according to compensation expert Kenneth Feinberg. The deadline for filing claims was Saturday, March 31, 2015. As of Sunday there were “455 death claims and 3,447 for injuries.” Many are calling for GM to extend the deadline, “because victims do not know yet whether they can sue General Motors Co., the new company that emerged from bankruptcy protection in July 2009.”
According to The CBS Evening News (2/2, story 5, 2:30, Glor, 5.08M) Sens. Ed Markey (D-MA) and Richard Blumenthal (D-CT) are asking GM to reconsider the deadline, “as over a third of the vehicles are still not fixed.”
USA Today (2/2, Healey, 10.32M) reported that GM’s count of victims “only included people in the front seats who would have been protected, presumably,” if not for the defective switches, and only those driving or riding in models that were specifically recalled.

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The FDA’s Adverse Reporting System Includes Numerous Incomplete Reports

The New York Times (2/3, B3, Thomas, Subscription Publication, 9.97M) is reporting that “the main system for keeping track of the dangerous side effects of prescription drugs is deeply flawed, primarily because drug makers are submitting incomplete information about the problems to the” FDA, “according to a new study by” the Institute for Safe Medicine Practices (ISMP), “a nonprofit group that tracks drug safety issues.” An FDA spokesman “acknowledged that adverse-event reports were often incomplete, and said improving the system was ‘of great interest’ to the agency.” But, “doing so ‘is challenging because of the voluntary nature of the reporting.’”
Similarly, The Wall Street Journal (2/2, Silverman, 5.67M) “Pharmalot” blog reports that although the ISMP says reports can only be considered reasonably complete when they include patient age, gender and event date, only 49% of reports contained that information. Additionally, the analysis found that 67% of death reports were of limited value due to incomplete information about the cause of death and the possible role of a medicine. Thomas Moore, an ISMP senior scientist, attributes the lack of completeness in reporting in part to the fact that the FDA’s adverse-alert system has not been updated since 2001 despite the fact that the pharmaceutical market has evolved immensely, yielding new interactions between drugmakers, patient, and consumers.

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Large Pharmaceutical Companies Are Outsourcing Drug Safety Monitoring Overseas

According to The Wall Street Journal (2/2, Mclain, Subscription Publication, 5.67M) more and more pharmaceutical companies are outsourcing their drug-monitoring operations to foreign countries like India. Outsourcing companies like Accenture are benefiting as major drug companies like AstraZeneca, Novartis, and Bristol-Myers Squibb contract out safety checks in order to lower costs and focus on R&D and marketing. The Journal goes on to explore in great depth the issues surrounding the practice, observing that some opponents of this type of work say that drug monitoring is hard to do, requiring significant experience, natural talent, and sufficient knowledge of biochemistry and pharmacology, and that the outsourcing trend brings greater risk that harmful side effects of drugs will be overlooked.

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GM Resists Effort To Extend Deadline For Ignition Compensation Claims

The Wall Street Journal (1/29, Bennett, Subscription Publication, 5.67M) is reporting that General Motors has rejected a request from Sens. Edward Markey (D) and Richard Blumenthal (D) to extend the claims deadline for their ignition switch compensation fund. In response GM said, “Our goal is to be just and timely in compensating the families who lost loved ones and those who suffered physical injury. We have conducted extensive outreach about the program. We previously extended the deadline until January 31, and we do not plan another extension.”

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Another Example of VA Neglect

The Los Angeles Times (1/28, Holland, 3.49M) is reporting that the U.S. government “has agreed to settle a lawsuit accusing the Department of Veterans Affairs of misusing its sprawling West Los Angeles health campus while veterans with brain injuries and mental impairment slept in the streets, people familiar with the agreement said Tuesday.” The settlement will require the VA “will develop a master land-use plan for the campus that identifies sites for housing homeless veterans.” The ACLU of Southern California brought the lawsuit contending “that the VA should develop housing for veterans on the 387-acre campus.” The ACLU of Southern California “accused the agency of illegally leasing land to UCLA for its baseball stadium, a television studio for set storage, a hotel laundry and a parking service.” In 2013 a Federal Judge “struck down the leases, saying they were ‘totally divorced from the provision of healthcare.’” More recently, US District Judge S. James Otero “halted construction of an amphitheater on the property.”

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GM Faulty Ignition Switch Death Claims Rise To 50

The AP (1/26, Krisher) is reporting that “with only five days left before the deadline to seek payments, compensation expert Kenneth Feinberg has decided that 50 death cases are eligible for money due to crashes caused by faulty General Motors ignition switches.” Seventy-five injuries have also been declared eligible in details released on Monday by Feinberg, who General Motors hired to oversee the claims. The GM fund “has received 338 death claims and 2,730 claims for injuries,” according to the AP. “Of those, 58 death claims have been rejected as ineligible for compensation, as have 328 injury claims. Feinberg is either reviewing or awaiting documentation on 230 additional death claims and 2,327 injury cases.”
According to Bloomberg News (1/26, Sandler, 2.94M) the 50 death claims ruled as eligible on Monday are four times larger than GM’s initial estimate. Bloomberg reports that Feinberg said his findings relied on circumstantial evidence. “GM engineers were looking for definitive proof of ignition switch failure,” Feinberg said, “So of course there will be a greater number of eligible death claims.” The story was also reported by Reuters (1/26), Auto World News (1/26, Ecarma, 1K), and Autoblog (1/26, Bigelow, 454K).

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According to GM There Are Nearly 900,000 Defective Ignition Switches Still On The Road

Auto World News (1/26, 1K) is reporting that GM filed documentation with the NHTSA last week that shows “almost 900,000 GM vehicles with potentially defective ignition switches are still being used.” General Motors “says that out of a recall of approximately 2,190,934 vehicles, just 1,229,529 vehicles have been repaired by dealers.” Furthermore Auto World News reports that “The total number of ‘unreachable’ vehicles is up to 80,122, according to the Detroit automaker.”

Source:    Auto World News

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