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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.
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.
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.
Former FDA Commissioner Dr. Robert Califf shares his views about drug approvals, regulations and safety concerns after stepping down from the giant agency.
Citing a Kaiser Health News investigation, Senate Judiciary Committee Chairman Chuck Grassley vows to examine the orphan drug program and possible fixes.
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.
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.
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.
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.
A breakdown of winners — and a few losers — in the sprawling Cures Act approved by the House.
The federal agency took 14 months to warn the public about the potential for infections. Officials say they acted as fast as they could.
Three lobbyists for every member of Congress in a push to pass a bill that increases research funding and speeds up approvals.
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.
The FDA’s drug-approval team is short more than 700 people and losing skilled staff members to the drug industry.
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
Pricey and unproven therapies that sound too good to be true probably are.
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.
Researchers examine the Food and Drug Administration’s “revolving door” regarding employees who worked on cancer and hematology drugs.
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.
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.
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