FDA Keeps Brand-Name Drugs On A Fast Path To Market ― Despite Manufacturing Concerns
The agency approved Gilead’s “game changer” hepatitis C cure, bypassing concerns raised by its own federal inspectors. The problems they found at the company’s main U.S. drug-testing laboratory in Foster City, Calif., were so bad, they recommended withholding approval.
Mysterious Vaping Lung Injuries May Have Flown Under Regulatory Radar
Doctors who saw patients with a mysterious lung illness in the past suspected vaping as the cause but didn’t know where to report such cases. “It wasn’t that I didn’t want to report it, it’s that there’s no pathway,” said one California pulmonologist.
Drugmakers Now ‘Masters’ At Rolling Out Their Own Generics To Stifle Competition
Known as “authorized generics,” in-house spinoffs of brand-name drugs quietly undermine the competition.
Five Things We Found In The FDA’s Hidden Device Database
The Food and Drug Administration released two decades of previously hidden data containing millions of injuries or malfunctions by medical devices. Here’s what we’ve learned so far.
More Than Half Of Surgical Stapler Malfunctions Went To Hidden FDA Database
The FDA reveals that 56,000 malfunctions associated with surgical staplers weren’t reported through its traditional public reporting system.
Price Check On Drug Ads: Would Revealing Costs Help Patients Control Spending?
As part of his plan to tamp down drug pricing, President Donald Trump wants pharmaceutical companies to provide cost information in drug ads — just like side effects.
Consumers Rejected Drug Plan That Mirrors Trump Administration Proposal
What to know about PBMs and rebates ahead of the Senate drug price hearing on — you guessed it — PBMs.
Big Pharma Gave Money To Patient Advocacy Groups Opposing Medicare Changes
A Kaiser Health News database shows that $58 million flowed from drugmakers to patient groups running national ads.
Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale
President Donald Trump and FDA officials have pointed to a surge in generic drug approvals, but a data analysis indicates almost half haven’t reached the market.
Secretive ‘Rebate Trap’ Keeps Generic Drugs For Diabetes And Other Ills Out Of Reach
Patients are often forced into using brand names because drug formularies favor them over cheaper competitors.