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 •  September 11

With help from David Pittman, Caitlin Oprysko, and Adam Cancryn THE FDA GETS REAL — The agency, in partnership with the Duke-Robert J. Margolis Center for Health Policy, will hold a public workshop Wednesday on developing a framework for how real-world data can be used in drug development and regulatory decision making. The 21st Century Cures Act...

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 •  August 4

The Senate unanimously approved a bill Thursday that would allow people facing life-threatening diseases access to unapproved experimental drugs, providing a victory for libertarian advocates who see government regulators thwarting patients’ rights. The bill, S. 204 (115), passed swiftly and easily in a Senate bitterly divided over health care. The...

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 •  July 24

Democrats are going straight at one of the top concerns of voters, using the rising cost of drugs to strike a more populist tone and counter President Donald Trump, who campaigned hard against the power of the drug industry, but took a friendlier stance after taking office. Congressional Democrats today laid out a three-pronged approach to lower...

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 •  July 17

With help from David Pittman FDA TO EXAMINE ANTI-COMPETITIVE PRACTICES BY DRUG INDUSTRY — The controversy over the cost of drugs will be front and center at FDA Tuesday as the agency takes a fresh look at the 1984 Hatch-Waxman law, which paved the way for generic drugs in the United States. FDA is looking at how parts of the law may be abused or...

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 •  June 17

Candidate Donald Trump made rising drug costs a signature issue during his campaign and beefed up his criticisms after the election, saying in January that the drug industry was "getting away with murder." The comments unnerved drug executives, but six months later, the industry is no longer in a state of panic. The administration is not proposing,...

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 •  June 15

House Republicans are teeing up another set of Obamacare repeal bills today, and Senate GOP leaders are not confident their Obamacare repeal bill will be ready for a vote before the Fourth of July recess. But first, senior administration officials are planning to meet Friday to discuss a forthcoming executive order on drug prices. SENIOR ADMIN...

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 •  May 25

With help from Catherine Boudreau and Jenny Hopkinson New York City may be rolling ahead with enforcing menu labeling after the Trump administration pulled the plug on a federal rule that was supposed to take effect earlier this month, but California says it’s going to wait for FDA. The California Department of Public Health told MA that the Golden...

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 •  May 11

Addiction specialists and public health officials on Thursday chided HHS Secretary Tom Price for belittling the use of medications considered the standard of care for the treatment of opioid addiction. The remarks irked specialists already worried by the Trump administration's law-and-order stance on drug control and its tentative plans, leaked to...

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 •  April 3

Big changes could be coming to the way new drugs are approved by the Food and Drug Administration. The Trump administration and incoming new leadership at the FDA, coupled with the implementation of the 21st Century Cures Act, signed into law by President Obama in December, may shake up the status quo for the prescription drug approval process. The...

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 •  March 15

Senate Republicans voted last night to kill an obscure Obama-era regulation because they wanted to make it easier for states to drug-test applicants for unemployment benefits. There’s just one problem: They may have just made it harder. Last August, the Labor Department finalized a rule that let states drug-test people claiming unemployment...