Pharmalot... Pharmalittle... The Weekend Nears
And so, another working week is drawing to a close. As you may recall, this is our treasured signal to daydream about weekend plans. And our agenda is rather modest. We hope to spend time with our short people, catch up on some reading and take a few naps. Then again, Mrs. Pharmalot may have other ideas. We shall see. But what about you? Anything interested planned? A shopping trip, perhaps? If so, you may want to buy a nice warm sweater. Maybe this is a chance to finalize plans if you have a few days off later this month. Or think about how next year will be different. Existential thoughts aside, have a wonderful time, bu...
Source: Pharmalot - December 13, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Court Evades US Concern Over False Claims And Side Effect Reports
Here is a ruling that is nothing but anticlimactic. After a few months of anticipation, a federal appeals court decided not to rule on an issue raised last summer by the US Department of Justice in a whistleblower case against a drugmaker – whether the failure to report adverse events can form the basis for filing a lawsuit citing the False Claims Act.
Here is the background, all of which is from our earlier story: A year ago, a federal court judge tossed a pair of whistleblower lawsuits that were filed by a former safety consultant, Helen Ge, who alleged Takeda misrepresented or altered descriptions of adverse events fo...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Attorneys General Want FDA To Rescind Painkiller Approval
Two months ago, the FDA caused a stir by ignoring the advice of its own advisory panel and approving the first opioid to contain only hydrocodone. The move was quickly criticized by patient advocates, because Zohydro ER is designed to be released slowly over a 12-hour period, but can be crushed, chewed or mixed with alcohol to provide a kick. In other words, there is potential for abuse and misuse.
Ironically, the approval came just days after recommending that commonly used prescription painkillers that contain hydrocodone, such as Vicodin, should be reclassified to a more restrictive ranking on the national law enforceme...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Japan Probes Pharma Magazine Ads Masquerading As Articles
The Japanese government is investigating whether numerous magazine articles intended to attract cancer patient may actually have been nothing more than embellished advertisements for cancer medicines and that several drugmakers paid the publisher of a monthly magazine to run the information, according to The Yomiuri Shimbun.
The Health, Labor and Welfare Ministry is determining whether the arrangement violated the Pharmaceutical Affairs Law, which bans advertising of cancer drug. And the paper reports that the ministry plans to urge the pharmaceutical industry to adopt voluntary rules to prevent a recurrence, although the ...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Says Female Sexual Dysfunction Pill May Not Be So Hot
Sprout Pharmaceutical has not lost desire for its female sex pill. Despite receiving a complete response letter from the FDA, the little drugmaker is appealing the agency decision. Nonetheless, the agency decision is only the latest instance in which the pharmaceutical industry has come up empty trying to market a drug to treat Hypoactive Sexual Desire Disorder in pre-menopausal women.
In fact, the Sprout once-a-day pill, which is called flibanserin, is the same drug that Boehringer Ingelheim failed to get approved three years ago. An FDA panel voted 10-to-1 the drug was not effective in increasing female libido, and the...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Hello, everyone, and how are you today? Once again, a shiny sun is hovering over the freezing cold Pharmalot corporate campus, which we hope will soon warm up enough so we may effectively tackle our to-do list. To help us along - you guessed it - we are brewing another cup of steaming hot stimulation. Our flavor is Southern Pecan, if you care. In any event, time to get cracking. So here are some tidbits. Hope your day goes well and be in touch...
Novartis CEO Envisions Tiered Pricing Plans For Africa (This Is Africa)
FDA Approves First Generic Of Cymbalta Antidepresssant (Associated Press)
Roche Signs Deal Worth Up To $600...
Source: Pharmalot - December 12, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Boehringer Is Fined Nearly $1M For Disappearing Documents
How much does it cost if potentially damaging documents disappear? How about $931,000? This is what Boehringer Ingelheim must pay in fines after a US federal court judge expressed dismay and outrage that the drugmaker failed to preserve “countless” files sought by patients who filed lawsuits claiming the Pradaxa bloodthinner caused excessive and, sometimes, fatal bleeding.
In a ruling this week, US District Judge David Herndon, who is overseeing more than 1,700 lawsuits, found that Boehringer executives acted “in bad faith” by failing to ensure that documents and files about Pradaxa development and marketing were p...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
FDA Has Plan To Limit Antibiotic Use In Food-Producing Livestock
After increasing debate, the FDA has implemented a plan to phase out the use of antibiotics in food-producing livestock, an issue that has generated mounting concern over the past few years that the widespread and, allegedly, inappropriate use of these medications jeopardize human health by causing resistance to the drugs. Not surprisingly, the plan was met with mixed reactions.
About 70 percent of medically important antibiotics sold in the US are for food animals, and most are used in feed without supervision of a veterinarian, according to Pew Charitable Trusts. The US Centers for Disease Control and Prevention recently...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Are Vicodin T-Shirts Just Pop Culture Or Tasteless And Harmful?
During an era when the abuse and misuse of prescription painkillers is a troubling and controversial issue, what should we make of shirts that boldly sport the names Vicodin, Adderall and Xanax? Are these drugs so widely accepted that the shirts are merely an ordinary barometer of popular culture? Or are these an inappropriate and tasteless attempt to glorify behavior that trivializes a serious problem?
As part of its argument to protest its Vicodin trademark, AbbVie recently filed a lawsuit against Kitson, a trendy Los Angeles retailer that has been marketing these t-shirts. And the drugmaker argues that the ‘designer d...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Task Force: Ban Sales Reps From Academic Medical Centers
In hopes of tightening conflict-of-interest policies at academic medical centers, a task force organized by the Pew Charitable Trusts has developed a new set of 15 recommendations that are more stringent than what was issued five years ago by the American Association of Medical Colleges. And one of the biggest recommended changes is banning pharmaceutical sales reps from campuses altogether (here are the recommendations).
“Effectively implementing strong, well-enforced COI policies at AMCs is critical to ensure that academic medicine can continue to engage in principled partnerships with industry, while protecting the in...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Rise and shine, everyone, another busy day is on the way. And while this is shaping up to be a rather cold one, in fact, the sun is shining strongly over the hectic Pharmalot corporate campus, where the short people are enduring their usual ritual of hustling off to their houses of learning. As for us, we are, of course, indulging with a cup of needed stimulation as we sort through our to-do list and decide what to leave in and what to leave out. Perhaps you can relate. In any event, here are some items of interest to help along your own ride. Have a smashing day and drop us a line if something interesting occurs...
CVS An...
Source: Pharmalot - December 11, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
A Medical Conference, A Tweet & A Drugmaker's Belated Response
Here is a real-life scenario that will give pause to any and every drugmaker that posts information at a medical conference. Last March, someone at a research conference held in Atlanta snapped a picture of the interim results from the first part of a Phase II study for a Medivir drug and then sent a Tweet. This apparently caused Medivir stock to jump and the NASDAQ OMX in Stockholm to halt trading.
Three hours later, Medivir issued a press release that contained actual study results and trading resumed. But the stock exchange was not pleased and has fined the drugmaker nearly $59,000, which is equal to twice the annual fe...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Some Democrats Scold Obama Over His Position On Trade Talks
In a rebuff to President Barack Obama, a half dozen Congressional Democrats have written to complain at the terms being proposed by the US Trade Representative in the ongoing Trans Pacific Partnership talks which are being held this week in Singapore. Specifically, they object to provisions pertaining to patents on prescription drugs they claim would affect the availability and cost of generic medicines.
The letter was delivered to the White House following the recent disclosure by WikiLeaks that the US Trade Rep was pushing various proposals that angered and upset a raft of consumer groups and patient advocates, who are c...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Supreme Court Rejects Pfizer In Neurontin Off-Label Marketing
In a setback to Pfizer, the US Supreme Court has left intact a $142 million award to Kaiser Foundation Health plan for marketing the Neurontin epilepsy drug for unapproved uses (back story). The court also allowed two other lawsuits – one brought by Aetna, the large insurer, and a class action that was filed on behalf of union health plans and other insurers – to proceed (see this).
The decision opens Pfizer to potentially still more payouts, especially if additional lawsuits are filed by other insurers or health plans that make similar claims. The lawsuits charged that Pfizer engaged in racketeering and induced physic...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
EU Says Pay-To-Delay Deals Drop; Fines J&J And Novartis
After applying greater scrutiny of pay-to-delay deals between brand-name and generic drugmakers, the European Commission finds that fewer such troubling patent settlements took place last year. At the same time, though, the agency has fined Johnson & Johnson nearly $15 million and Novartis about $7.5 million for allegedly conspiring to delay the generic introduction of a prescription pain patch in the Netherlands.
European antitrust regulators over the last few years have been cracking down on certain deals, in which a brand-name drugmaker offers a payment to a generic rival that then agrees to delay the launch of a co...
Source: Pharmalot - December 10, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
