In An Effort To Curb Drug Costs, States Advance Bills To Prod Feds On Importation
Legislatures in blue and red states alike are considering proposals that would allow them to import prescription drugs from Canada.
FDA
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FDA Head Vows To Tackle High Drug Prices And Drugmakers ‘Gaming The System’
In an exclusive interview, FDA Commissioner Scott Gottlieb describes what he’s doing to spur competition and bring down drug prices.
By Sarah Jane Tribble and Liz Szabo -
How The Shutdown Might Affect Your Health
For some federal health programs, a shuttered government means business as usual. But the congressional impasse over funding will hit others hard.
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Grassley Calls For ‘Corrective Action’ On Abuses In Herpes Vaccine Research
The Republican senator sent out letters to the Food and Drug Administration and HHS demanding an explanation about a rogue herpes vaccine trial.
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FDA Chief Says He’s Open To Rethinking Incentives On Orphan Drugs
The FDA’s Scott Gottlieb says the agency is focused on the big picture, and he wants to know why pharma churns out drugs for some rare diseases but not for others.
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Unregulated Herpes Experiments Expose ‘Black Hole’ Of Accountability
Controversial research methods by university researcher unlikely to prompt federal response or institutional change, experts say.
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Experts Tell Congress How To Cut Drug Prices. We Give You Some Odds.
Some of the nation’s most influential scientists recommend eight steps to lower drug prices. KHN takes the political temperature and tells you the chances of Congress acting on them.
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Cities, Counties and Schools Sidestep FDA Canadian Drug Crackdown, Saving Millions
Medicines are up to 80 percent cheaper north of the border and overseas, so U.S. localities are greasing a pharmaceutical pipeline that the feds warn is illegal and possibly unsafe.
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FDA Raids Florida Stores That Consumers Use To Buy Drugs From Canada
The federal agents warned store owners that importing drugs from foreign countries is illegal and that those helping “administer” such medicines could face penalties.
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To Wage War On Superbugs, FDA Clears Way For Scope With A Disposable Piece
Agency says a removable cap will lower the risk of antibiotic resistant infections but some experts see it as a modest step in curbing the sort of deadly outbreaks that occurred a few years ago.
By Chad Terhune -
The Orphan Drug Machine
FDA Moves To Guard Against Abuse Of ‘Orphan Drug’ Program
Following a KHN investigation, the Food and Drug Administration has moved to speed up approvals of “orphan drugs” while closing a loophole that allowed drugmakers to skip pediatric testing.
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Over-The-Counter Devices Hold Their Own Against Costly Hearing Aids
In a head-to-head comparison, several of the cheaper devices performed nearly as well as the expensive hearing aids. The study lends credence to lawmakers’ efforts to get the FDA to set standards for over-the-counter versions.
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FDA Ruling On Aussie Biotech Could Boost Congressman’s Investment
Innate Immunotherapeutics, whose largest shareholder is Buffalo-area Rep. Chris Collins, received FDA approval to begin U.S. trials of its drug for treating advanced multiple sclerosis.
By Rachel Bluth -
Nearly 1 In 3 Recent FDA Drug Approvals Followed By Major Safety Actions
More than 70 drugs approved from 2001 through 2010 ran into safety concerns later that resulted in withdrawals from the market, “black box” warnings or other actions.
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A Spoonful Of Kids’ Medicine Makes The Profits Go Up
Even as drug pricing issues continue to draw scrutiny, federal safety regulations and incentives offer drug companies a new avenue to get a sweet return on their development costs.
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Also Made In Mexico: Lifesaving Devices
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
By Sarah Varney -
‘The Trump Of Georgia’ Goes To Washington
With high-level connections in the Capitol, Parker "Pete" Petit aims to resolve regulatory issues that have haunted his wound care company.
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Trump’s Promise To Rein In Drug Prices Could Open Floodgate To Importation Laws
Sen. Bernie Sanders’ bill to allow Americans to buy cheaper medicines from Canada would bypass a requirement that blocked past legislative efforts over two decades.
By Rachel Bluth -
$89,000 Orphan Drug Gets A New Owner — And Likely A New Price
Marathon, maker of an expensive treatment for Duchenne muscular dystrophy, sells the drug for $140 million in cash and stock to PTC Therapeutics.
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Repeal & Replace Watch
By The Numbers: Trump’s Choice For FDA Chief Is Versatile, Entrenched In Pharma
The numbers show that President Trump’s choice for FDA commissioner, Scott Gottlieb, has long-standing ties to pharmaceutical companies as a board member or consultant and that he had to recuse himself multiple times while working at the FDA.