FDA Chief Says He鈥檚 Open To Rethinking Incentives On Orphan Drugs
The FDA鈥檚 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.
FDA
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Unregulated Herpes Experiments Expose 鈥楤lack Hole鈥 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鈥檚 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 鈥渁dminister鈥 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 鈥極rphan Drug鈥 Program
Following a KHN investigation, the Food and Drug Administration has moved to speed up approvals of 鈥渙rphan drugs鈥 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鈥 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鈥檚 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, 鈥渂lack box鈥 warnings or other actions.
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A Spoonful Of Kids鈥 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鈥 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鈥 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 鈥 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鈥檚 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.
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Three Key Senators Ask GAO To Investigate Possible Abuses Of The Orphan Drug Act
Amid an uproar over high drug prices, three GOP senators are asking the Government Accountability Office to investigate whether the Orphan Drug Act is being abused.
By Sarah Jane Tribble and Sydney Lupkin -
‘Right-To-Try’ Laws Expose Dying Patients To Exploitation, Ethicists Warn
More than 30 states have laws on the books to allow dying patients the right to try experimental treatments. But these treatments may not be covered by insurance, and ethicists worry vulnerable people could be exploited near the end of their lives. The laws may also duplicate a process the FDA already has in place.
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Repeal & Replace Watch
Former FDA Chief Cites 5 Things To Watch On Drug Approvals And Keeping Drugs Safe
Former FDA Commissioner Dr. Robert Califf shares his views about drug approvals, regulations and safety concerns after stepping down from the giant agency.
By Sydney Lupkin and Sarah Jane Tribble -
Grassley Launches Inquiry Into Orphan Drugs After KHN Investigation
Citing a Kaiser Health News investigation, Senate Judiciary Committee Chairman Chuck Grassley vows to examine the orphan drug program and possible fixes.