FDA taking on unapproved ear infection meds and Senate bill gives states say ... - NOLA.com |
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Senate takes up bill giving states more say on school testing After a one-week recess, the House and Senate return to Washington on Tuesday. The Senate is taking up a replacement bill for the No Child Left Behind accountability law enacted during the George W. Bush administration. The Every Child Achieves Actof 2015 would allow states to develop their own accountability systems, allowing them to decide how to use federally mandated testing for accountability. Supporters said it will give states a freer hand to replace the Common Core accountability standards, which many conservatives, including Gov. Bobby Jindal, now oppose. The bill continues the federally required two tests in reading and math per children in grades three through eight, and one exam in high school, as well as three science tests in grades 3-12. FDA plans action against unapproved meds for ear infections The Food and Drug Administrationannounced it intends to begin an enforcement action against companies that manufacture and/or distribute unapproved prescription ear drop medicine to relieve p0ain, infection and inflammation. The agency says that the unapproved drugs are frequently prescribed for young children suffering from ear infections and that their use puts patients at risk because their safety and effectiveness haven't been determined. "Taking enforcement actions against these unapproved products will protect patients from unnecessary risks," said Cynthia Schnedar, director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. "There are many FDA-approved prescription products to treat ear infections, so we expect little or no impact on patients from the removal of these unapproved and potentially unsafe products." Another case when disaster preparedness is critical Here's a study that residents in hurricane-prone Louisiana might want to ponder. The U.S. Department of Health and Human Servicessaid it just completed a study that showed people with end-stage renal disease (ESRD) who receive dialysis in advance of natural disasters, such as hurricanes, are significantly less likely to need an emergency department or hospitalization visit in the week following the disaster and less likely to die within 30 days of the disaster. According to HHS, the study showed that receiving early dialysis was associated with 20 percent lower odds of having an emergency department visit or 21 percent lower odds of a hospitalization after the storm, and 28 percent lower odds of death 30 days after the storm. "Every disaster holds the potential to impact health and often disproportionately affect people who are medically vulnerable, including people who require dialysis," said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response, and one of the report's authors. "This study provides the first evidence that receiving early dialysis in advance of potential disasters helps protect health and saves lives for dialysis patients and suggests that early dialysis should become a standard practice and protective measure." Ex-im bank posts closing notice it hopes will be temporary On July 1, the Export Import Bank posted this notice on its website: "Due to a lapse in EXIM Bank's authority, as of July 1, 2015, the bank is unable to process applications or engage in new business or other prohibited activities." That's because Congress hasn't acted to extend the authorization for the bank before its current mandate expired at midnight on June 30. The Senate voted before the July 4th recess 65-31 on a procedural vote to advance the export-import bank, which supporters of the bank saw as an encouraging sign. Sens. David Vitter, R-La., and Bill Cassidy, R-La., R-Baton Rouge, both voted no, saying they need to see significant reforms before they'll vote to continue the bank. Speaker John Boehner, R-Ohio, said he'd allow the House to consider the bank's future if the Senate eventually votes to reauthorize the Export-Import Bank, but under a process that would allow amendments to put restrictions on the bank's operations.The bill faces significant opposition, including from top GOP House Leaders, Kevin McCarthy, R-Calif., and Steve Scalise, R-Jefferson. Supporters of the bank said it plays a major role in helping businesses export U.S. products abroad by providing direct loans, loan guarantees and insurance. Opponents said the bank's record doesn't inspire confidence. "The Ex-Im Bank may help a few American businesses, but only at the expense of hurting others," said Rep. John Fleming, R-Minden. "In actuality, the bank only serves less than 1 percent of small businesses. More than 60 percent of the bank's finances go to 10 large corporations — companies that do not need taxpayer help." Rep. Garret Graves, R-Baton Rouge, said he'd like to see reforms in bank operations, but sees it playing an important role for Louisiana businesses. "Louisiana is the top export state (per capita) in the nation," Graves said. "We have five of the country's top fifteen ports and hundreds of thousands of folks in Louisiana rely upon the employment opportunities associated with international trade. We strongly support free trade and believe that, if given a level playing field, Louisiana's small businesses and large industries can compete on a global scale." |