[HHS Secretary Kathleen Sebelius’] action was politically motivated, scientifically unjustified, and contrary to agency precedent.Federal Judge Edward R. Korman • Denouncing, in very unambiguous terms, the decision by Health and Human Services Secretary Kathleen Sebelius to block the FDA’s decision that morning-after emergency contraception be made available over the counter, as opposed to requiring a prescription for girls age 16 or younger. Sebelius, with the vocal support of President Obama, had blocked the FDA’s proposed lifting of the rule in 2011 — Obama commented at the time: “I think it is important for us to make sure that we apply some common sense to various rules when it comes to over-the-counter medicine.” Judge Korman’s take? That the decision, in the midst of a contentious election season, was “arbitrary, capricious and unreasonable.” source
More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced. The F.D.A. has engaged in intolerable delays in processing the petition. Indeed, it could accurately be described as an administrative agency filibuster.Judge Edward R. Korman • Discussing the Food and Drug Administration’s delays in implementing the morning-after pill in a way that everyone could use it.
Previously, the pill required a prescription for girls aged 16 or under. In 2011, Health and Human Services secretary Kathleen Sebelius made a controversial move, blocking an FDA recommendation that the pill be available over-the-counter to anyone.
FDA approves first autonomous telemedicine robot for use in hospitals
The robot is ready to diagnose you.
As the FDA stated, ‘the existence of an adverse event report does not necessarily mean that the product identified in the report actually caused the adverse event’.A statement from Red Bull • Regarding a filing by the FDA on Friday revealing the company — much like Monster, Rockstar and 5-Hour Energy, who faced similar FDA filings earlier in the week — had seen its product associated with so-called “adverse events,” such as illness, that happened after a person consumed the beverage. Unlike Monster and 5-Hour Energy, Red Bull was not in any way associated with any deaths — rather, 21 reports of hospitalization for health problems such as heart issues and vomiting. And to be clear, the FDA’s reports in all cases do not claim the the beverages were the direct cause, and do not take into account outside factors, such as pre-existing conditions. All listed companies claim their products are safe.
Cracker Jack’D is a product line specifically developed for adult consumers and will not be marketed to children.Cracker Jack spokesman Chris Kuechenmeister • Seeking to tamp down concerns over his employers’ new planned product, Cracker Jack’D. What, you ask, is Cracker Jack’D? Really, you probably guessed it already — it’s a caffeinated version of the iconic snack treat, which makes sense, since caffeine is so dauntingly hard to come by nowadays. The plans have sparked predictable concerns — is there really a way to not market a product to kids when it’s candied popcorn? Cracker Jack’D hasn’t hit shelves yet, but the director of Center for Science in the Public Interest, Michael Jacobson, has already sent a letter to the FDA alleging violations of federal rules: “Boxes of Cracker Jack are famous for having a toy surprise inside. But what parent suspects that Cracker Jack might come with a surprising dose of a mildly addictive stimulant drug?” source
More info from the New York Times:
An agency spokeswoman, Shelly Burgess, said the agency had decided to release the records “in an effort to be transparent.” She added that the filing of a report did not show a product was at fault.
“If we find a relationship between consumption of the product and harm, F.D.A. will take appropriate action to reduce or eliminate the risk,” Ms. Burgess said.
Meanwhile, two Democratic senators, Richard Durbin of Illinois and Richard Blumenthal of Connecticut, sent a letter on Thursday to the F.D.A. commissioner, Dr. Margaret A. Hamburg, seeking a meeting to discuss energy drinks.
Both lawmakers have pressed the agency to tighten regulations of energy drinks, but it has responded that it has not seen sufficient evidence to do so as yet.
“There has been alarming evidence that energy drinks pose a potential threat to the public’s health,” the two senators wrote.
It’s worth noting that many medical doctors believe that people can drink two energy drinks in a day — the equivalent of 400 milligrams of caffeine — safely, without consequences. Also, the FDA states clearly in the above PDF that “there is no certainty that a reported adverse event can be attributed to a particular product or ingredient.”
The investigators observed approximately 100 vials of the steroid drug, which purports to be a sterile injectable drug, that had a greenish-black foreign material and a white filamentous [containing filaments] material inside.Steven Lynn, director of the FDA’s Office of Manufacturing and Product Quality • Speaking on the contamination of vials of an injectable steroid drug, intended for back pain relief, which resulted in the outbreak of fungal meningitis that has left 25 dead and 300+ afflicted across 18 states. The FDA tested 50 of the vials, produced by the New England Compounding Center (NECC), and all of them contained the lethal fungus. source
This case raises novel questions about the scope of the government’s authority to force the manufacturer of a product to go beyond making purely factual and accurate commercial disclosures and undermine its own economic interest — in this case, by making ‘every single pack of cigarettes in the country mini billboard’ for the government’s anti-smoking message.U.S. Court of Appeals Judge Janice Rogers Brown • In her opinion regarding the graphic packaging used for cigarette packs, which are federally-regulated. The Washington D.C. Court of Appeals struck down the ads in a 2-1 ruling Friday, with Brown writing that the government “has not provided a shred of evidence” that the packaging actually reduces smoking, and the court as a whole saying that the images violated corporate speech requirements. Five cigarette companies challenged the branding rules — which were upheld by another appeals court, raising the chances that the Supreme Court will rule on the issue.
Home HIV test approved by FDA: Good news for those who want to take an HIV test in the privacy of their own home. The Food and Drug Administration has approved an over-the-counter version of the OraQuick HIV test, which checks your saliva to see if you test positive for the disease that causes AIDS. The company behind the test, OraSure, doesn’t know a price, but says it’ll be below $60 — and hopefully available in 30,000 drug stores across the country. The FDA warns, though, that the test isn’t 100 percent accurate. OraSure notes that the test is about 92 percent accurate for positive results, and 99 percent accurate for negative results. (photo via Wikimedia Commons)
What’s going on here is basically a con game to suggest otherwise. What do con men do? They normally try to change their name. The FDA has thankfully stopped that.Sugar Association lawyer Dan Callister • Praising the Food and Drug Administration’s rejection of an attempt by the Corn Refiners Association to rename the recently-controversial “high fructose corn syrup” to something a tad less innocuous — “corn sugar” to be specific. Let’s face it — when giant agricultural industry groups fight in public, everyone wins.
Bad sushi alert: Yellowfin tuna in 20 states, commonly used in sushi products, has led to over 100 people suffering from a salmonella outbreak, the Food & Drug Administration said. The organization said that many of those sickened by the raw tuna, which isn’t commonly sold in stores, reported going for the ”spicy tuna” when ordering sushi. While nobody has died from the outbreak, 12 have been hospitalized. Next time you go out for sushi, you may want to stick to the avocado rolls. (photo by adactio on Flickr)
» The seized OJ contained a banned fungicide: The Food and Drug Administration has had to step up its orange juice-seizing lately, because a common fungicide called carbendazim, which, mind you, is safe in small amounts, is showing up in some of the imported orange juice. (Initially, this was reported to be a blanket ban, though the FDA says they’re only testing orange juice.) Here’s the kicker, though, from FDA spokeswoman Siobhan DeLancey: ”We don’t feel that this is a safety problem. This is more of a regulatory issue.” So basically, they’re seizing a crapload of OJ because it’s got a chemical that is apparently being poorly regulated. You would assume it’s dangerous to consumers, but it’s not. Wait … we’re not following this.
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