J&J Pays $2.2B Over Charges Of Improper Risperdal Marketing
After two years of negotiations, Johnson & Johnson and its subsidiaries have agreed to pay more than $2.2 billion to resolve criminal and civil lawsuits that alleged the healthcare giant illegally marketed its Risperal antipsychotic and two other medicines, and also paid kickbacks to physicians and Omnicare, the largest nursing home pharmacy to boost prescriptions. In announcing the deal, which resulted from multiple investigations into J&J business practices over the past decade, the US Department of Justice called the agreement one of the “largest healthcare fraud settlements in US history.” The criminal fine...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

FDA To Study Prescription Drug Advertising Aimed At Teenagers
Teenagers are, by and large, a vulnerable group that is also exposed regularly to prescription drug advertising. But how do they perceive the messages for medicines, especially those that treat afflictions common to that time of life? And to what extent are they able to sift through the information and assess the risks and benefits? In hopes of assessing teenage reactions to such situations, the FDA plans to run a randomized, controlled study by showing Internet- based promotional campaigns for fake medicines for acne and attention deficit hyperactivity disorder in order to compare their perceptions of the messages with yo...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

HHS Allows Rx Coupons And Co-Pay Cards Through Exchanges
For months, drugmakers have been anxious to know whether the Obama administration considers qualified health plans that are purchased through federal or state insurance exchange to be federal health programs. Why? Drugmakers are increasingly offering co-pay cards and discounts coupons to consumers to boost prescriptions and market share. But under the federal Anti-Kickback Act, drugmakers are not permitted to provide such subsidies directly to consumers who are insured by federal healthcare programs, such as Medicare and Medicaid. And so, there has been considerable anxiety over how the US Department of Health & Human ...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Only Glaxo Chinese Execs May Face Charges in Bribery Scandal
Two months after reports suggested the GlaxoSmithKline bribery scandal in China may have been coordinated at a high corporate level, a new report suggests that Chinese executives working for the drugmaker are likely to be charged with corruption, but not the corporation. If this plays out, as Reuters writes, this would be a relatively positive outcome for Glaxo. Any move by Chinese authorities to charge the drugmaker could result in major fines and disrupt operations in China, where sales recently fell 61 percent as Glaxo products were shunned in the wake of the scandal. What remains unclear is whether the episode will pro...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Only Glaxo Chinese Execs May Face Charges Over Bribery Scandal
Two months after reports suggested the GlaxoSmithKline bribery scandal in China may have been coordinated at a high corporate level, a new report suggests that Chinese executives working for the drugmaker are likely to be charged with corruption, but not the corporation. If this plays out, as Reuters writes, this would be a relatively positive outcome for Glaxo. Any move by Chinese authorities to charge the drugmaker could result in major fines and disrupt operations in China, where sales recently fell 61 percent as Glaxo products were shunned in the wake of the scandal. What remains unclear is whether the episode will pro...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Novartis Faces Criminal Complaint Over Diovan Research In Japan
For Novartis, the embarrassing scandal over Diovan research in Japan has taken another turn for the worse. A non-governmental organization has filed a criminal complaint that accuses the drugmaker of using manipulated clinical trial data, which was carried out by several universities, to exaggerate the benefits of the widely used hypertension treatment in its advertising, according to Yomiuri Shimbun. Medwatcher Japan charged that medical journals aimed at physicians and other health care providers ran advertising that cited the research and made misleading statements. And in doing so, the NGO claims that Novartis violated...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... Good Morning
Good morning and welcome to another working week. We hope the weekend was refreshing and you had a chance to enjoy. Now, though, that familiar routine of meetings and deadlines is upon us once again. You know what this means - a cup of stimulation is at hand. So please join us as we gear up for a busy day. And we can tell already that this will be a particularly busy one. Better than being bored, of course. Anyway, here are some tidbits. Have a grand day and do stay in touch...   Roche To Pay Up To $548M For Superbug Antibiotic (Bloomberg News) Merck Oral Hepatitis C Drugs Show High Cure Rates In Study (Reuters) Bristol F...
Source: Pharmalot - November 4, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Another Japanese University Finds Faulty Diovan Research
Yet another Japanese university has concluded that a study of the Diovan heart drug sold by Novartis contains questionable data. The findings comes less than a month after a government panel found the drugmaker may have violated Japanese law by using faulty data to promote its widely used heart drug, an offense that could lead to various penalties (here is the report). The report by the Japanese health ministry followed disclosures earlier this year by Kyoto Prefectural University of Medicine and Jikei University, which ran two of five studies that touted Diovan as capable of reducing heart attacks and strokes, that data w...
Source: Pharmalot - November 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Up And Down The Ladder... Job Changes
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us and we’ll share with it others. That’s right. Send us your announcements and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going, especially with all the layoffs. Despite the downsizing, there is movement. Here are some of the latest changes. Recognize anyone? And here is our regular feature. Send us a photo and we will spotlight a different person each week. This time around, we note that MyoKardia hired Tassos Gianakakos as ceo, succeeding founding ceo Charles...
Source: Pharmalot - November 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week is about to draw to a close. And once again, we will be getting an earlier-than-usual head start, thanks to the flukey use-it-or-lose-it days off policy. This means the menu of stories today will be brief as we segue into our weekend agenda, which includes spending fun time with our short people, catching up on all sorts of reading and visiting one of the Pharmalot ancestors. And you? Anything special planned? This is a lovely time of year to enjoy the great outdoors. Or you could touch base with old friends. You could also prepare for the upcoming election by researching the track record of th...
Source: Pharmalot - November 1, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

And Now, One Of Our Favorite Halloween Tunes...
We are showing our age, but not ashamed to enjoy ourselves. Now, if only the Great Pumpkin would appear... Read more (Source: Pharmalot)
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Cheaper By The Dozen? J&J Is Sued Over 340B Drug Discounts
In the latest squabble over the controversial 340B Drug Pricing Program, the AIDS Healthcare Foundation, which is an outspoken advocate for expanding services to patients, has filed a lawsuit accusing Johnson & Johnson for failing to offer required discounts on prescription medicines. After conducting an analysis, AHF claims that J&J was overpaid by more than $2 million between 2005 and 2013, but attempts to convince the health care giant to reclassify the specified drugs went nowhere. And AHF also maintains that J&J “deliberately, arbitrarily (and) oppressively” refusing to reclassify drugs for other organ...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Filling The Cupboard: FDA Releases Plan To Fight Drug Shortages
With dozens of drugs still in short supply, the FDA is touting two new steps to mitigate the problem. One is a strategic plan designed to improve its own response to shortages. The other is a proposed rule that requires all manufacturers of certain important prescription drugs, as well as biologics, to notify the FDA of a permanent discontinuance or a temporary interruption of manufacturing likely to disrupt supplies. The plan was made in response to an order from the Obama administration two years ago to resolve the shortage problem. Between 2005 and 2011, the number of new shortages quadrupled to 251. Although the figure...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

A Fading Vertex Drug Was Also Fastest To Become A Blockbuster
How is this for irony? The same week that Vertex Pharmaceuticals (VRTX) cuts 15 percent of its workforce due to plunging sales of its Incivek treatment for hepatitis C, the drug has been identified as having achieved blockbuster status faster than any other medicine. Incivek was launched in 2011, by the way, and surpassed Celebrex, which is sold by Pfizer (PFE) but was launched in 1999 by Pharmacia. The analysis was conducted by EvaluatePharma which reviewed quarterly US products sales and aggregated the first four full quarters after each drug launch in the region. Only five drugs have ever achieved blockbuster status in ...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs

Lousiana AG Sues Pfizer Over A "Fraudulent Zoloft Scheme"
Citing allegedly deceptive studies and a surreptitious marketing campaign, the Louisiana Attorney General has filed a lawsuit claiming that Pfizer fraudulently marketed its Zoloft antidepressant and caused the state Medicaid program to unnecessarily issue reimbursements for the drug. The lawsuit accuses the drugmaker of knowing there were “serious issues” with Zoloft efficacy and that early clinical studies demonstrated its pill was no better than a placebo. But Pfizer allegedly concealed this from regulators, physicians and patients with an elaborate scheme that included ghostwritten articles that were published in me...
Source: Pharmalot - October 31, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs