Senator Markey places hold on Obama's nominee to lead FDA(Reuters) - Democratic U.S. Senator Edward Markey of Massachusetts said on Monday he placed a hold on President Barack Obama’s nominee to head the Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants opioid-approval matters to be reviewed by an FDA advisory committee and believes the committee should consider the risk of addiction and abuse during the approval process. He also wants the agency to rescind approval of OxyContin for children and convene an advisory panel to guide that process. “Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment,” Markey said in a statement. A “hold” is a procedure by which a senator can prevent a measure from being voted on by the full Senate. The nominee, Dr. Robert Califf, a cardiologist and researcher, is widely expected to be approved when the Senate votes on the nomination later this year, although critics argue his ties to the pharmaceutical industry are too close. A spokesman for the Department of Health and Human Services, which oversees the FDA, said it had made addressing the opioid crisis “a top priority.” “Work at FDA and across HHS will continue on this important effort,” spokesman Kevin Griffis said in a statement. “HHS will be in touch directly with the Senator regarding his concern.” The Senate Committee on Health, Education, Labor and Pensions voted earlier this month to confirm Califf as FDA commissioner, a position open since Dr. Margaret Hamburg stepped down last February. Califf, who joined the FDA a year ago as a deputy commissioner, previously held senior positions at Duke University, where he founded a large academic research center that received more than half its funding from the drug industry. He has also led multiple large-scale, company-funded clinical trials and published more than 1,200 papers. His interest in streamlining the clinical trial process dovetails with those of patient groups and members of Congress who are eager to see new drugs brought to market faster. U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5 percent to 47,055, propelled by prescription painkiller and heroin abuse, according to the U.S. Centers for Disease Control and Prevention. Drug overdoses are seen as a major contributor to recently rising death rates among middle-aged white Americans. Since 2000, deaths from powerful, highly addictive opioids have jumped 200 percent, the CDC said, with those addicted to prescription painkillers, such as hydrocodone, increasingly turning to widely available, often cheaper heroin. politicsNews
senator market places hold obama nominee lead fda reuters democratic senator edward market massachusetts said monday placed hold president barack obama nominee head food drug administration agency agrees reform process approving opioid painkillers market wants matters reviewed fda advisory committee believes committee consider risk addiction abuse approval process he also wants agency rescind approval oxycontin children convene advisory panel guide process last year fda approved new pediatric use oxycontin without conveying advisory committee even though guidelines note fda decisions relate controversial issues matters relating children particularly advisory committee empanelment market said statement a hold procedure senator prevent measure voted full senate the nominee robert cliff cardiologist researcher widely expected approved senate votes nomination later year although critics argue ties pharmaceutical industry close a spokesman department health human services oversees fda said made addressing opioid crisis top work fda across hhs continue important effort spokesman kevin griffin said statement hhs touch directly senator regarding the senate committee health education labor pensions voted earlier month confirm cliff fda commissioner position open since margaret hamburg stepped last february cliff joined fda year ago deputy commissioner previously held senior positions duke university founded large academic research center received half funding drug industry he also led multiple clinical trials published papers his interest streamlining clinical trial process details patient groups members congress eager see new drugs brought market faster deaths drug overdose hit record increasing percent propelled prescription painkiller heroin abuse according centers disease control prevention drug overdose seen major contributor recently rising death rates among white americans since deaths powerful highly addictive opioids jumped percent cdc said addicted prescription painkillers hydrocodone increasingly turning widely available often cheaper heroin politicsnews
Your task is to classify the provided input as real or fake news. Label 0 is meant for fake news, Label 1 is for real news. TEXT: Senator Markey places hold on Obama's nominee to lead FDA(Reuters) - Democratic U.S. Senator Edward Markey of Massachusetts said on Monday he placed a hold on President Barack Obama’s nominee to head the Food and Drug Administration until the agency agrees to reform its process for approving opioid painkillers. Markey wants opioid-approval matters to be reviewed by an FDA advisory committee and believes the committee should consider the risk of addiction and abuse during the approval process. He also wants the agency to rescind approval of OxyContin for children and convene an advisory panel to guide that process. “Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate to controversial issues or matters relating to children are particularly well-suited to advisory committee empanelment,” Markey said in a statement. A “hold” is a procedure by which a senator can prevent a measure from being voted on by the full Senate. The nominee, Dr. Robert Califf, a cardiologist and researcher, is widely expected to be approved when the Senate votes on the nomination later this year, although critics argue his ties to the pharmaceutical industry are too close. A spokesman for the Department of Health and Human Services, which oversees the FDA, said it had made addressing the opioid crisis “a top priority.” “Work at FDA and across HHS will continue on this important effort,” spokesman Kevin Griffis said in a statement. “HHS will be in touch directly with the Senator regarding his concern.” The Senate Committee on Health, Education, Labor and Pensions voted earlier this month to confirm Califf as FDA commissioner, a position open since Dr. Margaret Hamburg stepped down last February. Califf, who joined the FDA a year ago as a deputy commissioner, previously held senior positions at Duke University, where he founded a large academic research center that received more than half its funding from the drug industry. He has also led multiple large-scale, company-funded clinical trials and published more than 1,200 papers. His interest in streamlining the clinical trial process dovetails with those of patient groups and members of Congress who are eager to see new drugs brought to market faster. U.S. deaths from drug overdoses hit a record in 2014, increasing 6.5 percent to 47,055, propelled by prescription painkiller and heroin abuse, according to the U.S. Centers for Disease Control and Prevention. Drug overdoses are seen as a major contributor to recently rising death rates among middle-aged white Americans. Since 2000, deaths from powerful, highly addictive opioids have jumped 200 percent, the CDC said, with those addicted to prescription painkillers, such as hydrocodone, increasingly turning to widely available, often cheaper heroin. politicsNews
Your task is to classify the provided input as real or fake news. Label 0 is meant for fake news, Label 1 is for real news. TEXT: senator market places hold obama nominee lead fda reuters democratic senator edward market massachusetts said monday placed hold president barack obama nominee head food drug administration agency agrees reform process approving opioid painkillers market wants matters reviewed fda advisory committee believes committee consider risk addiction abuse approval process he also wants agency rescind approval oxycontin children convene advisory panel guide process last year fda approved new pediatric use oxycontin without conveying advisory committee even though guidelines note fda decisions relate controversial issues matters relating children particularly advisory committee empanelment market said statement a hold procedure senator prevent measure voted full senate the nominee robert cliff cardiologist researcher widely expected approved senate votes nomination later year although critics argue ties pharmaceutical industry close a spokesman department health human services oversees fda said made addressing opioid crisis top work fda across hhs continue important effort spokesman kevin griffin said statement hhs touch directly senator regarding the senate committee health education labor pensions voted earlier month confirm cliff fda commissioner position open since margaret hamburg stepped last february cliff joined fda year ago deputy commissioner previously held senior positions duke university founded large academic research center received half funding drug industry he also led multiple clinical trials published papers his interest streamlining clinical trial process details patient groups members congress eager see new drugs brought market faster deaths drug overdose hit record increasing percent propelled prescription painkiller heroin abuse according centers disease control prevention drug overdose seen major contributor recently rising death rates among white americans since deaths powerful highly addictive opioids jumped percent cdc said addicted prescription painkillers hydrocodone increasingly turning widely available often cheaper heroin politicsnews