FiercePharma: Laid-off Pfizer reps join OT lawsuit, 6-14-11

ANOTHER COMPANY REP HERE. JUST CURIOUS IF ANY RECENT OR CURRENT LEGAL ISSUES REGARDING OVERTIME PAY HAVE BEEN RAISED / SETTLED WITH YOUR COMPANY? SERIOUS RESPONSES ONLY PLEASE AND BEST OF LUCK TO THOSE OF YOU REMAINING SA REPS WHO ARE STILL TRYING TO HANG ONTO YOUR POSITIONS AT SA. THANKS!


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Today's Top Stories
1. Laid-off Pfizer reps join OT lawsuit
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Chalk this up to unintended consequences. Laid-off Pfizer sales reps are flocking to a longstanding class action seeking back overtime pay, BNet Pharma reports. Pfizer's moves to pare back its sales force may inadvertently cost the company more than it expected.
Pfizer has laid off thousands of reps over the past several years, including hundreds of job cuts in connection with the 2009 Wyeth merger. There are a fair number of ex-Pfizer sales folks floating around. Meanwhile, an overtime-pay lawsuit filed in 2006 by former rep Anthony Coultrip has been slowly advancing in the courts.
Now, those two trends appear to have collided. In March, the U.S. Supreme Court turned away a case over sales-rep overtime, leaving intact some lower-court rulings that required OT pay--a ruling that could give the Pfizer case a boost. And now, Pfizer's laid-off reps are quickly signing on to that class action, BNet says.
Overtime pay has been a big issue for pharma sales forces in recent years. Almost every Big Pharma has fought--or is now fighting--a lawsuit over whether reps are exempt from or subject to wage-and-hour laws. Novartis, Merck and Boehringer Ingelheim are on the hook for back OT pay as a result of those suits, while cases against AstraZeneca, Abbott Laboratories, and, of course, Pfizer remain pending.
- read the BNet piece
Related Articles:
Sales reps win as Supremes refuse overtime appeals
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Read more about: Pfizer, lawsuit, Pharma sales reps, overtime pay
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2. Now on the market, Benlysta meets skeptics
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Human Genome Sciences' new lupus drug Benlysta was approved to great fanfare earlier this year. But according to a Washington Post story, some doctors aren't convinced that the drug is worth its price tag, so some patients might not ever get a chance to try it.
Anecdotal reports on the drug are strong. The WP's report begins by detailing the story of a McLean, VA, woman who got great results from the drug during a clinical trial. Meanwhile, one rheumatology expert told the Post that only 10 to 20 percent of his patients are likely to benefit from the drug, and there's no way to tell whether it would be helpful even for them in the long run. Another rheumatologist expressed skepticism about Benlysta because he's not sure who would benefit from it based on the data so far.
As the Post notes, lupus patients are in a difficult spot. They have been hopeful about the first new lupus treatment in 50 years; however, it might prove ineffective for them. Furthermore, they may never get to try it because of unimpressed doctors and a high price tag.
An HGS executive countered those worries by saying that so far, payers haven't been reluctant to foot the bill for Benlysta. Its price is in line with other biotech meds. Doctors will come to understand how and how well it works in time. "Rheumatologists are learning as they go, and they'll have to experiment in their own practices to see how well it works," said HGS VP Barry Labinger (as quoted by the Post). "There are no simple outcomes with lupus."
- get the story from the WP
Related Articles:
EMA nod for key new drugs from GSK, Merck, BMS
GSK, Human Genome gear up for Benlysta launch
Read more about: Human Genome Sciences, Benlysta
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3. Humira patient says Abbott 'stalled' warning
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

What happens if regulatory timetables conflict with real life? That's one question posed by a lawsuit accusing Abbott Laboratories of failing to warn patients that its arthritis drug Humira could cause serious fungal infections. A 69-year-old man has sued Abbott in Tennessee, saying that his almost-fatal case of histoplasmosis might have been prevented--or at least diagnosed sooner--had Abbott quickly acted on indications that the drug could boost the risk, Bloomberg reports.
Back in September 2008, the FDA ordered Abbott to warn patients and doctors of an increased risk of histoplasmosis in Humira patients, with the highest risk for patients who lived in the Mississippi and Ohio River valleys and also took methotrexate, according to court documents. Twenty-six days later, Frederick Delano--who lived in that region and took methotrexate--started Humira therapy.
The following February, Delano was diagnosed with histoplasmosis after VA doctors failed to identify the infection for a full month. Abbott contacted healthcare providers about the histoplasmosis risk more than a year later in May 2010. "In 2008, Fred and his physicians got no warning whatsoever that the medication which he thought would help could, in fact, kill him--and nearly did," Delano and his wife, Frances, allege in the complaint (as quoted by Bloomberg). The also say the company "stalled" on issuing the warning to protect its sales. Humira is a major blockbuster, with 2010 sales of more than $6 billion.
For its part, Abbott says it did everything the FDA asked it to do--and on time--effectively blaming the agency for any delay in getting the histoplasmosis information out. "Abbott's risk evaluation and mitigation plan was submitted to the FDA in December 2008 and approved in April 2010," a spokesperson told Bloomberg. "Abbott contacted healthcare providers well within the timeframe required by the FDA."
- read the news from Bloomberg
- get more from Pharmalot
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One in four biologics gets safety warning
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Read more about: Humira, drug safety, lawsuit, Abbott Labs
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4. GSK dealmaking: OTC buyers, China buyouts
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

GlaxoSmithKline ($GSK) has seen no shortage of potential buyers for the OTC brands it put on the block a few months ago, CEO Andrew Witty (photo) says. And that's just one of the several tidbits of news Witty doled out at an industry meeting in Brussels. Another tidbit: GSK's appetite for emerging markets deals isn't as sharp as it used to be.
Regarding the OTC brands, GSK is trying to sell a basket of products that together account for about $815 million in annual sales, mostly in the U.S. and Europe, Reuters reports. The assortment includes the diet pill Alli, which never really lived up to its initial hype. Rival drugmakers have been eyeing the products, Witty says, and so have private equity investors. The sale process is expected to move into higher gear over the summer.
Witty also addressed GSK's newly announced buyout of a flu vaccine joint venture in China. The company will pay £24 million for the 51 percent in that JV, the share now held by its partner Shenzhen Neptunus Interlong Bio-Technique. The company will continue to scout for more small acquisitions in that country, he said. But as for emerging-markets deals in general? Witty expects fewer bolt-on buyouts as time goes by, because those deals have grown too expensive--"ky-high," in his words.
- read the Reuters news
- check out the Evening Standard piece
- get more from Reuters
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GSK chief: Emerging markets sales do the job
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Read more about: GlaxoSmithKline, OTC, Andrew Witty, emerging pharmaceutical markets
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5. Claris CEO says FDA woes nearing end
By Tracy Staton Comment | Forward | Twitter | Facebook | LinkedIn

Claris Lifesciences is getting closer to getting back in the FDA's good graces. CEO Arjun Handa says that the company has tapped an external consultant for quality-control advice, Dow Jones reports. Plus, the company is adding new manufacturing checks and controls, aiming to resolve its regulatory differences and get all its products back on the U.S. market.
Claris has been under an import ban from the FDA since November 2010. The agency imposed the restrictions after finding multiple manufacturing violations at its plant in India, and the company has been working to resolve those issues by buying new machines, installing new technology, and taking other steps to make sure the problems don't recur, Handa says.
It's probably no consolation to Claris or its investors, but the company obviously isn't alone in its long-running import ban. Fellow Indian drugmaker Ranbaxy Laboratories is still working on resolving problems with the FDA that began in September 2008--problems that might just interfere with its ability to take advantage of first-to-market exclusivity on potentially the biggest generic drug in history, copycat Lipitor.
- get the story from Dow Jones
Related Articles:
FDA blocks Claris imports on plant troubles
Claris aims for more generics-supply deals
Read more about: FDA, India, Claris
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