News Analysis: Interviews, Op-eds, & Editorials
J&J Bedaquline and the Evolving Role for Accelerated Approval: Confirming Safety, Not Efficacy?
December 4, 2012. FDA Beat. Discussions during an advisory committee review Janssen’s TB drug bedaquiline showed some interesting thinking around accelerated approval and how much uncertainty can be acceptable—especially when it comes to safety. Yttri warned called “approval of drugs based on the promise of benefit” a “dangerous practice.” Read More
Death by Medicine
November 2012. NRC President Dr. Diana Zuckerman calls for closing loopholes in FDA rules in this guest post on the Huffington Post. Read More
Allergan drops bid for FDA approval to promote Lap-Band for teens
October 3, 2012. LA Times. The maker of the Lap-Band weight-loss device, Allergan Inc., has dropped its controversial bid for federal approval to market the product for overweight teens. Doctors already can perform Lap-Band surgery on minors with parental consent. The FDA approval would have allowed Allergan to market Lap-Band specifically for younger people. Read More
F.D.A. Bans BPA From Baby Bottles and Sippy Cups
July 17, 2012. The New York Times. The FDA bans bisphenol A in baby bottles and children’s drinking cups. Read More
U.S. Plans IDs to Track Medical Device Safety
The Food and Drug Administration proposed a new rule that would require each medical device to have a unique code that could improve tracking and catch safety problems earlier. Read More
Johnson & Johnson Unit to Halt Urinary Implants
New York Times. June 6, 2012. Johnson and Johnson halts production of mesh urinary implants due to lawsuits and many women who were harmed by the devices. Read More
FDA rule clears medical devices without human testing
The Orange County Register. May 18, 2012. “Patients and doctors would be shocked to learn how this is done,” said Diana Zuckerman, president of the National Research Center for Women and Families. “The 510 (k) program is the weakest and most nonsensical program in the FDA.” Read More
How does the FDA monitor your medical implants? It doesn’t, really.
ProPublica. May 3, 2012. “And after being notified of patient harm, manufacturers can minimize their own responsibility if they point the blame elsewhere,” said health policy expert Diana Zuckerman, president of the National Research Center for Women & Families. Read More
Investigation: Most medical devices implanted in patients without testing
March 27, 2012, CBS News. This article reports on Consumer Reports’ investigation on the testing of medical devices. NRC President, Dr. Diana Zuckerman is quoted on the need for unique serial numbers for medical devices and stronger FDA standards to increase safety. Read More
Consumer Reports: Dangerous Medical Devices
Dr. Diana Zuckerman is quoted in the Consumer Reports investigation for their May issue that finds that most medical implants have never been tested for safety. Read More