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.
Sydney Lupkin
Sydney Lupkin was a data correspondent for KFF Health News until November 2019.
Showing 1 - 20 of 43
-
-
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.
-
Drugmakers Master Rolling Out Their Own Generics To Stifle Competition
Known as “authorized generics,” in-house spinoffs of brand-name drugs quietly undermine the competition.
By Jay Hancock and Sydney Lupkin -
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.
By Sydney Lupkin and Christina Jewett -
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.
By Julie Appleby and Sydney Lupkin -
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 KHN 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.
By Sydney Lupkin and Jay Hancock -
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.
By Jay Hancock and Sydney Lupkin -
Tainted Drugs
When Medicine Makes Patients Sicker
The Food and Drug Administration is supposed to inspect all factories, foreign and domestic, that produce drugs for the U.S. market. But a KHN review of thousands of FDA documents — inspection records, recalls, warning letters and lawsuits — reveals how drugs that are poorly manufactured or contaminated can reach consumers.
By Sydney Lupkin Photos by Heidi de Marco -
Government Investigation Finds Flaws In the FDA’s Orphan Drug Program
A probe by the Government Accountability Office cites breakdowns in the Food and Drug Administration program that approves drugs for rare diseases.
By Sarah Jane Tribble and Sydney Lupkin -
Like Clockwork: How Daylight Saving Time Stumps Hospital Record-Keeping
One of the most popular electronic health records software systems used by hospitals, Epic Systems, can delete records or require cumbersome workarounds when clocks are set back for an hour, prompting many hospitals to opt for paper records for part of the night shift.
-
Drugmakers Funnel Millions To Lawmakers; A Few Dozen Get $100,000-Plus
Drugmakers' contributions to lawmakers have peaked as surging drug prices emerge as a hot-button political issue. In the past decade, Congress has received nearly $79 million from 68 pharma PACs, run by employees of companies that make drugs treating everything from cancer to erectile dysfunction.
By Emmarie Huetteman and Sydney Lupkin -
Pfizer Settles Kickback Case Related To Copay Assistance For $24M
The drugmaker agreed to a settlement with the Justice Department over allegations that it funneled copay assistance money through a foundation to Medicare patients.
-
Drugmakers Blamed For Blocking Generics Have Jacked Up Prices And Cost U.S. Billions
The Trump administration is shaming brand-name drugmakers who refuse to sell samples so generics can be made from their products.
-
Patient Advocacy Groups Take In Millions From Drugmakers. Is There A Payback?
Kaiser Health News launches “Pre$cription for Power,” a groundbreaking database to expose Big Pharma’s ties to patient groups.
-
Patients Overpay For Prescriptions 23% Of The Time, Analysis Shows
Researchers at the University of Southern California analyzed millions of prescriptions and concluded that close to a quarter paid copays that exceeded the cost of the drugs.
-
Big Pharma Greets Hundreds Of Ex-Federal Workers At The ‘Revolving Door’
A KHN data analysis finds that the door of opportunities connecting Capitol Hill, the federal government and the drug industry likely spins in Big Pharma’s favor.
-
Right After Trump Blamed High Drug Prices On Campaign Cash, Drugmakers Gave More
At a political rally in March, President Donald Trump said drug prices are “outrageous” and blamed campaign contributions. Drugmakers funneled nearly $280,000 to Congress the very next day.
By Sydney Lupkin and Elizabeth Lucas
Sign Up For Our Newsletter
Stay informed by signing up for the Morning Briefing and other emails: