Report On FDA’s Tool For Tracking Side Effects In Drugs Finds Incomplete Data
“Not only does this data show that manufacturer performance is weak, by not revising its systems, the [Food and Drug Administration] is also missing an opportunity to enhance to post-marketing surveillance," said Thomas Moore, an ISMP senior scientist.
Stat:
FDA System For Reporting Side Effects Has Its Own Side Effect: Incomplete Data
Once again, an analysis of the U.S. system for reporting patient injuries caused by prescription drugs is yielding an unexpected side effect — incomplete information. And a key reason is inconsistent reports filed by drug makers, according to the Institute for Safe Medicines Practices, a nonprofit that tracks drug safety issues. The Adverse Event Reporting System, which is run by the Food and Drug Administration, is the primary tool for collecting information about side effects that may be caused by medicines. Consumers and physicians may voluntarily report problems to the agency or to a drug maker. But drug makers are required to investigate and then report any side effect that may be attributable to one of their products. (Silverman, 7/13)
In other pharmaceutical news —
The Associated Press:
Investors: 'Pharma Bro' Shkreli Was Shady-And Profitable
The jury at the securities fraud trial of "Pharma Bro" Martin Shkreli has heard investors accuse the quirky former biotech CEO of repeatedly giving them the runaround when they tried to pull their money out of his failing health care hedge fund. But the government witnesses have made a concession that the defense hopes plays in its favor: In the end, they made a killing. (7/13)
