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.
FDA
441 - 460 of 469 Results
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‘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.
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Repeal & Replace Watch
Five Quick Ways HHS Secretary Tom Price Could Change The Course Of Health Policy
After a tough fight by Democrats, Senate Republicans confirmed Rep. Tom Price’s nomination to head the Department of Health and Human Services. He will have the authority to upend some current practices.
By Julie Rovner -
The Orphan Drug Machine
Drugmakers Manipulate Orphan Drug Rules To Create Prized Monopolies
Drugmakers have brought almost 450 orphan drugs to market and collected rich incentives but nearly a third of those products aren’t new or were repurposed multiple times, an investigation shows.
By Sarah Jane Tribble and Sydney Lupkin -
In Search Of A Vaccine To Vanquish The Plague
The scourge of the Middle Ages could still be pretty scary as a bioterrorism weapon, so scientists are trying to find a way to immunize people against it.
By Lydia Zuraw -
Grilled About Deadly Superbug Outbreaks, Execs At Scope Maker Olympus Take Fifth
Lawyers who deposed top company officials in a civil case say they declined to answer questions about their failure to warn American hospitals of infection risks. Industry giant Olympus also is the subject of a criminal probe.
By Chad Terhune -
Grab Bag Of Goodies In 21st Century Cures Act
A breakdown of winners — and a few losers — in the sprawling Cures Act approved by the House.
By Sydney Lupkin and Steven Findlay -
Deadly Infections Linked To Heart Surgery Device Highlight Holes In FDA Monitoring
The federal agency took 14 months to warn the public about the potential for infections. Officials say they acted as fast as they could.
By Chad Terhune and Christina Jewett -
A Frenzy Of Lobbying On 21st Century Cures
Three lobbyists for every member of Congress in a push to pass a bill that increases research funding and speeds up approvals.
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Long-Stalled FDA Reform Sits On Senate’s Lame-Duck Calendar
The legislation would give federal officials more flexibility in evaluating the effectiveness and safety of drugs and devices and add billions of dollars to NIH funding. But critics say it could endanger patients’ safety and doesn’t do enough to stop spiraling drug prices.
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FDA’s Drug Approval Team Copes With 700 Unfilled Jobs As Industry Lures Staff
The FDA’s drug-approval team is short more than 700 people and losing skilled staff members to the drug industry.
By Sydney Lupkin and Sarah Jane Tribble -
FDA Faults 12 Hospitals For Failing To Disclose Injuries, Deaths Linked To Medical Devices
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
By Chad Terhune -
Ask Emily
Beware Of Unapproved Stem Cell Treatments
Pricey and unproven therapies that sound too good to be true probably are.
By Emily Bazar -
The Orphan Drug Machine
A Golden Ticket That Fast-Tracks A Drug Through The FDA
A voucher awarded to companies that find treatments for rare childhood diseases can be sold to the highest bidder — and then used to speed up approvals for much more common drugs.
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When Drug Reviewers Leave The FDA, They Often Work For Pharma
Researchers examine the Food and Drug Administration’s “revolving door” regarding employees who worked on cancer and hematology drugs.
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Congressman Decries Olympus’ Failure To Warn U.S. Hospitals About Tainted Scopes
U.S. Rep. Ted Lieu (D-Calif.) renews his call for tightened laws that would force manufacturers to notify the Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices.
By Chad Terhune -
Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks
Newly released court documents show that after Tokyo-based Olympus Corp. alerted customers in Europe in 2013, it told its U.S. operation not to warn U.S. doctors and hospitals. Since then, at least 35 patients have died after being sickened in outbreaks.
By Chad Terhune -
American ‘Stem Cell Tourists’ Don’t Have To Travel Abroad, Study Says
Treatments marketed as everything from anti-aging applications to therapies for degenerative diseases are increasingly available at commercial clinics in the U.S., but their growing numbers raise ethical and regulatory concerns in the scientific community.
By Zhai Yun Tan