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Posts Tagged ‘FDA’

Pharma and biotech sales (and training) leaders, take note: the FDA is actively training doctors to sniff out your transgressions and turn you in.

The FDA has recently launched an e-learning course in order to educate the medical community on misleading drug promotions.

From the FDA’s press release: The FDA’s Office of Prescription Drug Promotion announced Monday the launch, with MedScape, of the e-learning course, which offers continuing education credits for healthcare professionals. The course is part of Bad Ad, a program designed in 2010 to raise awareness about misleading and untruthful drug ads. It’s aimed at healthcare professionals, but anyone can take it, the agency said. The office has developed several case studies based on warning letters the FDA has sent to drug companies, representing common problems.

You can launch the course here (anyone, in fact, can go through it). The screen shot below shows the structure of the course:

FDA course menu

Of particular interest is Module 5, where actors representing sales reps engage in questionable promotional practices to demonstrate violative sales tactics. This should be examined carefully by every commercial biopharma organization.

FDA Rep ecourse

Hat tip to Corey Nahman for the heads-up.

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TODAY’S NEWS

Why one hospital is restricting drug sales reps (news clip). Interesting perspectives on sampling.

Possible heart problem with HIV drug combo – The U.S. Food and Drug Administration said on Tuesday that HIV drugs Invirase and Norvir might lead to an abnormal heart rhythm when used in combination, according to preliminary data the agency is reviewingmore

Salix‘ antibiotic gets thumbs up from FDA panel – Salix Pharmaceuticals’ diarrhea drug Xifaxan should be cleared to treat patients with a debilitating liver disorder, but more study would still be needed after approval, a U.S. Food and Drug Administration advisory panel said on Tuesday. FDA’s outside advisers, in a 14-4 vote, said the antibiotic appeared to help patients with the liver condition, but that the company’s single clinical trial did not look at the sickest patients or follow subjects long enough given that the drug would be used until patients get a liver transplant or diemore

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From EyeonFDA blog – Is Congress the new FDA?

JUST FOR FUN

More Olympics goodies – the 20 Funniest Figure Skating Faces.

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TODAY’S NEWS

FDA warning letters to Lilly, Bayer, Amylin, Cephalon.

Wow: ARBs for hypertension reducing Alzheimer’s symptoms? – Drugs commonly used to lower blood pressure, sold by AstraZeneca Plc, Sanofi-Aventis SA and Merck & Co., may also reduce the risk of developing Alzheimer’s disease. Researchers from Boston University analyzed the medical records of more than 800,000 U.S. veterans and found those taking angiotensin receptor blockers were up to 24 percent less likely to develop dementia than patients on other medications. Patients already diagnosed with Alzheimer’s disease were half as likely to be admitted to a nursing home and had a 17 percent reduced risk of dying if they were taking the medicationsmore

FTC wants to put a stop to the “pay-to-delay” deals – Jon Leibowitz will hold a press conference today to ask Congress to include a provision in the health care reform bill to end deals in which brand-name drugmakers offer payments or other inducments to generic rivals to delay copycat versions of best-selling medsmore

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Social Media, Opportunity, and Serendipity – my guest post on the Hive Awards blog.

JUST FOR FUN

Visual awesomeness. Photo of Martian dune field. Quite spectacular!

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TODAY’S NEWS

FDA panel to Forest on new use for heart drug: thumbs down – Federal health advisers on Monday unanimously rejected a new use of Forest Laboratories’ hypertension drug for patients at risk of heart failure. The Food and Drug Administration’s outside panel of heart specialists voted 8-0 against approving Bystolic to prevent death or hospitalization caused by heart failure, according to an agency spokeswoman….more

Withdrawal rates, Oxycontin, and selective publication of details. Sigh, Purdue.

Vivus’ new erectile dysfunction drug: fast results – Vivus Inc. on Monday reported positive test results for its erectile dysfunctional drug candidate avanafil, saying most men who took the drug were able to have sex within 15 minutesmore

Vertex lost less than $650 million in 2009. Well, that’s a relief!

The Medicines Company cutting 10% of workforce. Ouch.

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$3M CME grant with NO strings attached? Wow (Pfizer-Stanford)!

JUST FOR FUN

Obnoxious guitar design. Really. Obnoxious.

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Pharma “e-stuff” has been on my mind lately, having recently attending the ePharma Summit in Philadelphia. Here are some random links that have surfaced which might be of interest to you:

Pfizer doing some interesting web 2.0 applications with “Pfizerpedia” – Karl Kapp‘s overview (with more helpful links); a .pdf case study; article from Information Week.

Manhattan Research on the use of Search all along the Treatment continuum. Linked from Fabio Gratton‘s blog.

On PharmaExec.com: The Future of Media and Social Influence Marketing.

Learn the Art of Communicating with People using social networks for Health and Wellness. From Fard Johnmar‘s blog (free report link). Also, from the same blog, Questions about the Effect of Physician Social Networks on prescribing patterns.

Activated Patients, and Why Pharma Should Care. From Pharma 2.0 blog.

From the Eye on FDA blog: Two More Pharmas jump into YouTube, and the federal government going big also into Web 2.0.

And, two items from Medical Marketing and Media:

Social media renders commercial model obsolete? Ummm, a little overstated there…!

Marketers should offer holistic solutions, not just drugs.

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The FDA gives a hint of hope for the long-delayed Eli Lilly/Daiichi Sankyo drug prasugrel. Burrow deep inside this 357-page FDA document just posted online, and you’ll find this jargony but significant sentence: The Division recommends approval of prasugrel for reduction of myocardial infarction in patients with ACS who are managed with PCI.

Glaxo the latest Big Pharma to announce major upcoming cutsBritish drugs company GlaxoSmithKline Plc.  is set to announce about 6,000 job losses when it posts results on Thursday, the Sunday Telegraph newspaper said. The cuts by Glaxo, the world’s second largest drugs company after U.S. group Pfizer, are part of Chief Executive Andrew Witty’s strategy to meet the challenges facing the industry, including increased competition from generic drug makers, the British newspaper said.

Teva gets FDA OK for generic version of J&J‘s Risperdal. And, Takeda gets approval for new GERD drug Kapidex.

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