News & Commentary on Prescription Drug & Medical Device Lawsuits
A November 7th New York Times article by Sabrina Tavernise discusses the recent FDA ruling surrounding trans fats.
Nutrition is an ever-changing area of research. Many of the guides to healthy cooking and eating methods once thought ideal are now seen to be quite unhealthy and harmful to our health. During the 1950’s, 1960’s…
Julian Hattem of RegWatch, a blog curated by TheHill, reports in a piece that the US Food and Drug Administration is “not sold” on a recent pharmacy compounding bill.
The mixing and distributing of medications happens at various compound pharmacy clinics found all throughout the United States, and these compounding clinics have been the…
According to a recent report by HealthToday.com, The U.S. Food and Drug Administration believes certain commonly-used drugs that should be more difficult to obtain. Painkillers such as Lortab and Vicodin contain hydrocodone (a synthetic opiate) which is often abused and highly addictive; tighter controls on these types of prescriptions may be a good way to…
This shows that the FDA is more interested in protecting pharmaceutical companies than patients. Note how Woodcock doesn’t want to force new trials because that requires human experimentation, which has risk. A smarter regulator would realize that the risks increase in proportion to the size of the user base of the drug. And allowing any…
Here’s a little more in-depth analysis of the generic drug argument before SCOTUS:
Andre Mura, litigation counsel at the Center for Constitutional Litigation in Washington, D.C., said the government’s argument was troubling. “There were suggestions that the FDA shouldn’t be second-guessed, but as the Court said in Wyeth v. Levine, the FDA approval process
…
On the one hand it’s disappointing to see them give up the fight. On the other, at least this won’t lead to a SCOTUS ruling that strips the FDA of more power. The fear of such a ruling is why I suspect the FDA gave up.
(Reuters) – The government has dropped its push for
…
Drug marketing 101: The FDA approves drugs for specific ailments. Drug companies may not market the drug to treat any other type of ailment. If they do, it’s called off-label marketing and it is illegal.
Drug marketing 201: It’s often very profitable to engage in off-label marketing, because the fines you pay are less than…
Did you know that the FDA doesn’t have subpoena power? That’s the power to make a company hand over a document. Every single attorney in the U.S. can subpoena a document from a pharmaceutical company, but the FDA (which is supposed to regulate pharmaceuticals) doesn’t have that power.
Citing a recent spike in pharmaceutical recalls,
…
This is a great step towards greater transparency:
WASHINGTON — The Food and Drug Administration launched a website Tuesday where patients and health care professionals can find safety information about recently approved drugs and vaccines.
On the Postmarketing Drug Safety Evaluations site, the FDA plans to share what it has learned about the safety of
…
I agree that visits to China should be at the top of the FDA priority list. I’m not sure about increasing the speed of drug reviews, though, unless that speed increase comes from increased staff. Asking existing staff to do more in less time is a recipe for another Vioxx disaster.
NEW YORK (Reuters) –
…