Current Events

Almost eight years after gaining statutory power to mandate food recalls, the FDA is officially publishing information to help industry understand when the agency will use its authority.

In a guidance document scheduled for publication in the Federal Register today, the Food and Drug Administration uses a question-answer format to explain how, when and why the government will force companies to recall food for people and animals.

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ARMENIA, Wis. — The groundwater that once ran cool and clean from taps in this Midwestern farming town is now laced with contaminants and fear. People refuse to drink it. They won’t brush their teeth with it. They dread taking showers.

Rural communities call it their own, private Flint— a diffuse, creeping water crisis tied to industrial farms and slack regulations that for years has tainted thousands of residential wells across the Midwest and beyond.

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Federal officials for weeks have been on the hunt for the underlying source of a bacterial contaminant in raw chicken that has sickened more than 90 people in 29 states, 11 percent of them identified in New York.

A multi-drug resistant bacterium — Salmonella infantis — has cropped up in a wide range of chicken products. The bacteria are capable of repelling 13 major antibiotics, which makes illnesses caused by the microbes tougher to treat.

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It's a scene played out in many homes across America -- parents place their baby on a bed or sofa, thinking the child is safe while Mom or Dad slips away for a few moments.

But new research finds that falls from beds and sofas pose a greater risk to children than many parents believe.

More than 2.3 million children under the age of 5 were treated in U.S. emergency departments for "soft furniture-related injuries" between 2007 and 2016, an average of 230,026 injuries per year, according to the study. It is to be presented Monday at the American Academy of Pediatrics (AAP) national conference, in Orlando, Fla.

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At the end of September, Amarin Corp. teased some early findings for Vascepa, its preventive medicine for people at risk of heart disease. The claim was astounding: a 25 percent relative risk reduction for deaths related to heart attacks, strokes and other conditions. Headlines proclaimed a potential game changer in treating cardiovascular disease. And company shares quickly soared, from $3 a share to about $20.

Vascepa is Amarin’s only product. The company wants to turn its pill made of purified fish oil into a cash cow, allowing it to staff up both in the United States and abroad so it can sell doctors and millions of consumers on its medical benefits. Although the product has been on the market for more than five years, its first TV ad campaign rolled out this summer in anticipation of the study findings.

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Subaru and Toyota are recalling about 165,000 U.S. vehicles they manufactured jointly after discovering a defect that could lead to the engine stalling in rare cases.

The affected vehicles were assembled by Subaru at a joint venture operation in Japan.

The recall covers about 140,000 Subaru vehicles in the U.
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(CNN)The US Food and Drug Administration is not doing enough to prevent medical devices such as pacemakers and insulin pumps from being hacked, a report from the US Department of Health and Human Services' Office of the Inspector General said Thursday.

"FDA had plans and processes for addressing certain medical device problems in the postmarket phase, but its plans and processes were deficient for addressing medical device cybersecurity compromises," the report says.

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The US Food and Drug Administration is alerting patients of another recall of medicine used to treat high blood pressure, for a potential cancer risk due to contamination. This time, SciGen is recalling certain lots of irbesartan.

The recalled lot will have "Westminster Pharmaceuticals" and "GSMS Inc." on the label, according to the FDA list.
Another heart medicine, valsartan, has also been recalled recently due to contamination.

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(Reuters) - A proposed class action lawsuit in San Francisco federal court accuses Wells Fargo of making tens of thousands of automatically dialed, or “robo,” calls to cell phones without consumers’ consent.

Filed on Thursday on behalf of a nationwide class, the lawsuit accuses Wells Fargo of calling wrong numbers with auto-dialing equipment and failing to honor requests to stop. The complaint seeks triple damages under the U.S. Telephone Consumer Protection Act, or up to $1,500 for each call.

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Four pharmacy benefit managers must face a lawsuit alleging they breached their duties as administrators of employee health insurance plans’ drug benefits by causing Mylan NV to raise the EpiPen allergy medication’s price, a federal judge has ruled.

U.S. District Judge Paul Magnuson in St. Paul, Minnesota on Friday denied motions by CVS Health Corp, Express Scripts Holdings, UnitedHealth Group Inc and Prime Therapeutics to dismiss a proposed class action by participants in employee health insurance plans.

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Earlier this year, the Centers for Disease Control and Prevention released a stunning statistic. Seventy-two thousand people, it estimates, died of drug overdoses in 2017. The huge increase in deaths is largely due to heroin and powerful synthetic opioids like fentanyl.

One of the tools being used to fight that wave of deaths is the drug naloxone. It's been called the Lazarus drug for its ability to revive people dying from overdoses. It can be injected or simply administered through a nasal spray. (The spray form of the drug is known by the brand name Narcan.)

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