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Reuters blog archive
from Alison Frankel:
FDA confirms: It’s considering rule change for generic labels
Last month, when I wrote about the Obama administration's apparent flip-flop on the question of federal pre-emption of product liability claims against generic drugmakers, I mentioned a curious footnote in the Justice Department's Supreme Court amicus brief in Mutual Pharmaceutical v. Barrett. All the wrangling over liability for generics, which are required by law to use the same labels as the brand-name drugs they replicate, could be unnecessary, Justice hinted. "This office has been informed that Food and Drug Administration is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances," the brief said. "If such a regulatory change is adopted, it could eliminate pre-emption of failure-to-warn claims against generic-drug manufacturers."
I should have given the footnote more attention. In the last couple of weeks, it has prompted speculation by a number of pharma websites about whether the FDA really intends to upend longstanding policy barring generics from altering their labels, and, if so, what that portends for their product liability exposure. On Wednesday, I emailed the FDA to ask. In an email response, an FDA representative confirmed what the Justice Department footnote suggested: "FDA is considering a regulatory change that would allow generic manufacturers, like brand-name manufacturers, to change their labeling in appropriate circumstances," the agency said. "FDA intends to provide an opportunity for public comment with respect to any such proposed changes to its regulations."
The FDA email, according to Kurt Karst of Hyman, Phelps & McNamara (and the FDA Law Blog), is the first confirmation of what FDA watchers have been anticipating since the U.S. Supreme Court's 2011 ruling in Pliva v. Mensing freed generics from liability for failing to warn consumers about dangerous side effects.
So, will generics welcome the opportunity to provide consumers with more information about potentially dangerous side effects of their drugs? Not bloody likely.
from The Great Debate:
Plan B: where politics trump science. Again.
By Amanda Marcotte
The views expressed are her own.
Wednesday morning Health and Human Services Secretary Kathleen Sebelius overruled the FDA’s long-awaited decision taking age restrictions off Plan B emergency contraception. The change would have allowed those 16 and under to buy Plan B, moving it from behind the pharmacist counter and into the shelves alongside aspirin and condoms. But now that won’t happen.
The decision confounded the medical community as well as the women’s rights world. Since no HHS Secretary has ever overruled an FDA decision of this sort before, the widespread assumption, best articulated by Matt Langer at Wonkette, was that Sebelius was working under “marching orders from an administration now fully in re-election mode” and fearful of getting a reputation as somehow “soft” on teen sexual activity.
from Oddly Enough Blog:
It’s a black day for candy lovers…
Okay, take that black stuff out of your mouth, put it on the floor, and back away.
That's just me helping the government warn folks about the danger of eating too much licorice.
from Tales from the Trail:
Salmon ‘chanted evening?
The one word that leaped out of President Obama's State of the Union address to Congress wasn't "optimism," "business," "teachers," "economy" or "budget."
To those who listened to the speech on National Public Radio, the memorable term was "salmon," writ large in a word cloud NPR compiled from its listeners after Obama finished.
from The Great Debate:
The government’s waning support of breast cancer?
By Sally Pipes
The opinions expressed are her own.
Breast Cancer Awareness month, which wound down last month, appeared to get plenty of government support.
Health and Human Services Secretary Kathleen Sebelius held a teleconference in recognition of national mammography day. She and Thomas Frieden, director of the Centers for Disease Control, touted a new program to promote awareness. The Vice President's wife, Dr. Jill Biden, spoke about the importance of early detection, and Barack Obama himself, in a Presidential proclamation, said that "we reaffirm our commitment to supporting breast cancer research."
from The Great Debate:
Let cancer patients have this pill
One more day -- or week, or month, or perhaps even a year. It may not seem like much time, but patients with incurable cancer know better. For Christi Turnage of Mississippi, who lives with stage IV breast cancer, it means seeing her daughter start kindergarten, celebrating her 27th wedding anniversary, and watching her sons graduate from college.
Her family and her oncologist credit her quality of life for the past two years to the drug Avastin, a biologic that combats cancer by cutting off the blood supply to tumors. But advanced breast cancer patients like Turnage have been forced to spend precious time battling something else: the possibility that federal regulators will vote today to remove approval of Avastin for their treatment.
from The Great Debate:
Don’t demonize drug samples. They are crucial to our healthcare
The following is a guest post by Grace-Marie Turner, founder and president of the Galen Institute, a non-profit research organization focusing on patient-centered solutions to health reform.
Medical researchers recently confirmed a link between chronic fatigue syndrome and a recently discovered retrovirus. Armed with this knowledge, some doctors are now prescribing HIV drugs to their sickest patients.
from Shop Talk:
Check Out Line: Watch those health claims, FDA tells green tea sellers
Check out federal regulator's warning to green tea sellers.
The U.S. Food and Drug Administration issued warning letters to Dr Pepper Snapple Group and Unilever over their use of health claims to sell green tea products.
The agency, which regularly sends warning letters to companies that have violating manufacturing, marketing and testing requirements, took issue with Dr Pepper Snapple Group's claim that its Canada Dry Green Tea Ginger Ale is "enhanced with 200 mg of antioxidants from green tea and Vitamin C". FDA said the statement did not comply with rules governing nutrient content claims.
from Environment Forum:
Genetically engineered fish, anyone?
Would you eat a genetically modified fish? What about pork from a pig with mouse genes? Beef from cattle with genes spliced to resist "mad cow" disease?
These are questions Americans may soon have to answer for themselves if the U.S. health regulators allow the sale of a genetically engineered salmon. The company that makes it, Aqua Bounty Technologies Inc <ABTX.L>, expects an agency decision by year's end.
from The Great Debate:
Overweight? No pill will fix that
The following is a guest post by David Warner, a Philadelphia-based journalist and health writer. The opinions expressed are his own.
Would it not be wonderful if there were a pill for everything?
Have some kind of irritating bug? Pop an antibiotic, even if it’s a virus. Want to quit smoking? The heck with willpower, take something, wear a patch. Sex life on the wane? Men, swallow that little blue pill. Depressed? Can’t sleep? There are so many pills to choose from. Just watch all those late night commercials.
