After heparin recall, wholesaler waited a year to act on contamination reports
A U.S. wholesaler of heparin sat on a complaint of contamination for nearly a year, an FDA investigation has revealed, well after the blood-thinner was recalled in 2008 for contaminated raw materials.
According to the Wall Street Journal, which reviewed t
Can we expect companies to release recall info faster?
Want to find out about drug recalls when they happen? It seems FDA may need to get more involved. That may be one lesson to take from last week's announcement that in August, Pfizer recalled 191,000 bottles of Lipitor after several patients reported a mus
MI judge’s ruling swings the pendulum in favor of the individual mandate
A judge that upholds the legality of the individual mandate does exist! Yesterday, U.S. District Judge George Steeh dismissed the Thomas More Law Center’s central arguments against the Affordable Care Act’s individual mandate and denied a requested injunc
The Insider: Cutting through the Chatter to Focus on What Matters
The ACA 6 month check up (the patient seems to be a little under the weather)
This edition of the Insider is devoted to a high level overview of where reform stands politically at the six-month mark. As regular publication resumes, we’ll be digging into
FDA: improving safety of global drug supply top priority
The FDA has made strengthening the safety and integrity of the global drug supply chain one of its top four strategic priorities for FY2011-2015, and is seeking public comment on refining these agency-wide goals.
Community Catalyst, which has been working
Insurers behaving badly
You may have heard that many health insurers across the country (including several major insurers such as WellPoint, UnitedHealth Group, Aetna, Cigna, and Humana) have been announcing the discontinuation of new child-only policies. These are insurance pro
"This was not one of our best moments": J&J execs go before Congress again
Though Congress adjourned Wednesday, the House Oversight and Government Reform Committee went ahead and heard yesterday from two Johnson & Johnson/McNeil executives and the FDA over the ‘phantom recall’ of defective adult Motrin earlier this year.
To
"I don't think they understand the real risk": Brant Zell on the drug safety bills and why we shouldn't wait for another heparin
Tomorrow, the House Energy and Commerce Subcommittee on Health hears from FDA, industry and consumer advocates about a discussion draft introduced last week that would improve the safety and oversight of the drug supply, and begin to bring foreign standar
Six months in: The new health law gives us the key to better care
Our fourth post celebrating the six month anniversary of the Affordable Care Act.
Six months ago today, the Affordable Care Act was signed into law. Since then, the new health law has offered some concrete advances, including some that go into effect toda