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Drugmakers have brought almost 450 orphan drugs to market and collected rich incentives but nearly a third of those products aren鈥檛 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 鈥 and a few losers 鈥 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鈥 safety and doesn鈥檛 do enough to stop spiraling drug prices.
The FDA鈥檚 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 鈥 and then used to speed up approvals for much more common drugs.
Researchers examine the Food and Drug Administration鈥檚 鈥渞evolving door鈥 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.
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.
The Food and Drug Administration has introduced a simplified form that doctors will use to seek FDA approval to treat seriously ill patients with experimental drugs after other options run out.
But the authors caution against concluding that folic acid is ineffective.
After a wave of sometimes-deadly superbug infections, the agency last year ordered a recall of Custom Ultrasonics machines used to disinfect medical scopes. Now, with little explanation, it is backing off.
The FDA expands its purview over all tobacco products -- including e-cigarettes, cigars, pipe tobacco -- but the new regulatory process could permit many products sold in the U.S. to remain so for up to three years.
The problems persist even after Congress in 2012 gave the FDA enhanced powers to respond when drug levels are low.
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