Monday, May 31, 2010

Generic Drugmakers Lose Preemption Argument

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A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.

In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .

The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote.

Some background: In 2003, GlaxoSmithKline released Wellbutrin XL, an extended-release form of the pill that could be taken just once daily and used a membrane-release technology, which meant the drug would seep at a controlled rate through a membrane that passed through the entire body intact, The Legal Intelligencer writes.

Since the membrane technology was patented, generic manufacturers who wanted to release a version of Wellbutrin XL were forced to devise their own methods of delayed release. Impax and Teva used a different matrix technology and their drugs achieved peak concentrations in two hours. Wellbutrin XL and generic versions made by other companies achieved this in five hours.

For patients who switched, the faster release made the drug less effective in combating depression, according to the lawsuit, which alleges neither Impax nor Teva took steps to warn doctors or patients that their versions worked differently or disclosed side effect complaints.

“Levine teaches that the ultimate responsibility rests with the drug maker, not the FDA, to either adequately inform the public or remove the drug from the market,” Schiller wrote. “Defendants have offered no compelling reason why Congress would have given generic drug makers favored status.”

Original News Source:
http://www.pharmalot.com/2010/05/generic-drugmakers-lose-preemption-argument/

Sunday, May 30, 2010

Novo Nordisk Pulls Insulin From Greece Over Money

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More fallout from the European debt crisis. Novo Nordisk has yanked its diabetes product from Greece after the government instituted substantial price cuts of up to 25 percent on hundreds of medicines (see background), which the Danish drugmaker claims would force it to lose money on top of the $36 million it is already owned by Greek government.

More than 50,000 Greek diabetics use Novo Nordisk’s insulin product, which is injected with a fountain pen-like device and, not surprisingly, a patient association called the move a “brutal capitalist blackmail” and a “violation of corporate responsbility,” according to the BBC.

Pavlos Panayotacos, whose 10-year-old daughter has diabetes, wrote to Novo Nordisk ceo Lars Sorensen to say that, “as an economist I realize the importance of making a profit, but healthcare is more than just the bottom line. As you well may know, Greece is presently in dire economic and social straits, and you could not have acted in a more insensitive manner at a more inopportune time.”

However, Sorensen is having none of it. He wrote back to say the decision was prompted by “the irresponsible management of finances by the Greek government which puts both you and our company in this difficult position,” the BBC reports. A Novo Nordisk spokesman says the issue is not about killing people and, to compensate, the drugmaker will make available its glucagen insulin free of charge.

Novo Nordisk is also concerned that the price cuts will have a ripple effect elsewhere in Europe, because other countries use Greece for as a reference point for setting drug prices.

Saturday, May 29, 2010

Generic Drugmakers Lose Preemption Argument

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A generic drug may be bioequivalent with a brand-name med and approved by the FDA, but that doesn’t mean a generic drugmaker is shielded from a product-liability lawsuit. That’s what a federal judge ruled in refusing to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.

In a 29-page decision, US District Judge Berle Schiller cited the US Supreme Court’s decision in Wyeth vs. Levine, which determined FDA approval does not shield drugmakers from state lawsuits, and concluded that generic drugmakers also have a duty to warn about any new side effects that may occur after the FDA has approved their medicines. Several generic drugmakers recently petitioned the US Supreme Court to review their liability .

The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote

Monday, May 24, 2010

Orgasm Inc: Female Sexual Dysfunction Is curable

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Next month, an FDA advisory committee will meet to review a Boehringer Ingelheim pill to tackle FSD, or female sexual dysfunction . However, a growing group of psychologists, academics and public health advocates contend that FSD isn’t an authentic medical condition, or at least not the sort of problem that should be treated with drugs. Bandied about but never proven is the statistic that 43 percent of women suffer from this affliction (background).

And so just in time for the regulatory show comes a new documentary called Orgasm Inc. (subtitled The Strange Science of Female Pleasure), which premieres in New York on Thursday and explores the issue by examining a host of views and products, including the Orgasmatron and an effort by Vivus Pharmaceutical to develop and sell a topical treatment. “A lot of this is about marketing,” filmmaker Liz Canner tells Newsweek. “They are trying to sell disorders.” You can read more here.

Sunday, May 23, 2010

Congress Will Hold J&J Recall Hearing This Week

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Despite a request by a fellow committee member to postpone a hearing into the Johnson & Johnson recall scandal, House Committee on Oversight and Government Reform chair Edolphus Towns, a New York Democrat, is proceeding with plans to hold the session this coming Thursday, May 27.

You may recall earlier this week that Darrell Issa, the committee’s ranking member and a California Republican, asked Towns for a postponement because J&J ceo Bill Weldon is unable to atttend - he underwent back surgery the other day - and the FDA, meanwhile, has not yet completed its inspections of McNeil Consumer Healthcare facilities. J&J’s McNeil unit was cited for quality-control problems that affected about 40 over-the-counter meds for infants and children, and failed to properly follow up complaints that certain batches of its Tylenol Arthritis Relief Caplets had a musty smell .

In arguing for a postponement, Issa wrote Towns; “It is my opinion that Mr. Weldon’s presence at this hearing is of the utmost importance, if for no other purpose than to restore brand confidence. According to credible sources, the McNeil manufacturing facilties presently under investigation may be ‘out of control’ and not following internal standard operating procedures, mess less FDA regulations. The parent company must be held accountable for the actions of its subsidiary and the only way to achieve this is by Mr. Weldon’s appearance before our committee.”

Towns, however, appears to believe that it’s best to strike while the iron is hot. And so he accepted a substitute for Weldon - Colleen Giggins, who heads J&J’s worldwide consumer healthcare business. The other person who was invited to testify is Josh Sharfstein, the FDA deputy commish. Towns had previously invited FDA commish Margaret Hamburg, and there was no reason given for the switch.

Source: Pharmalot.com

Thursday, May 20, 2010

Pfizer Sales Reps In India Strike Over Job Category

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Sales reps who work for Pfizer’s Wyeth unit in India are angry that their jobs are being reclassified. Known locally as field workers, the sales are protesting what they consider an illegal change in their job classification to professional service officers, which means they will no longer be eligible for union membership, PharmaBiz reports.

And so the Federation of Medical Representatives Association of India is holding a one-day strike today. Wyeth reps will demonstrate and stage a massive dharna (a fast conducted at the door of an offender) in front of the Pfizer India office in Chennai, along with members of the Tamil Nadu Medical & Sales Representatives Association, which will protest in front of Pfizer offices throughout Tamil Nadu.

Ramesh Sunder, general secretary of TNMSRA, alleges Pfizer has already started ‘deunionization,’ even though legal formalities are not yet completed. Wyeth management allowed reps to engage in collective bargaining and signed several wage settlements with their union, but Pfizer reps have no union. The PSO is a non-bargaining job category and since the reps aren’t accepting the switch, Pfizer management has started to illegally convert reps to PSOs by force, he alleged.

Reference..
Pharmalot

Monday, May 17, 2010

DTC Ads Not Biggest Driver Of Drug Spending: Study

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If you enjoy discussions of price elasticity, do we have a paper for you. Economic simulations suggest that the expansion in broadcast DTC ads may have been responsible for 19 percent of the overall growth in prescription drug spending from 1994 to 2005, with over two-thirds driven by increased demand due to expanded advertising and the remainder due to higher prices. All this is according to a new paper published by the National Bureau of Economic Research .

But while DTC advertising was deemed significant, the authors conclude “it has not been the primary force driving the growth in overall prescription drug expenditures.” [UPDATE: Curiously, the conclusion seems to contradict the bottom-line findings.] The study examined the separate effects of broadcast and non-broadcast DTC ads on price and demand, using an “extended time series of monthly records” for all advertised and non-advertised drugs in four major therapeutic classes - painkillers, cholesterol, heartburn and insomnia - spanning 1994 to 2005. This period encompassed notable shifts in FDA guidelines and expanded DTC advertising.

Those classes were chosen since they include one or more drugs with relatively high DTC spending and others with little or no DTC, according to the paper. The four therapeutic classes had combined sales of $48.9 billion in 2005, or 24 percent of total drug spending for US DTC advertising. DTC ads in these classes amounted to $1.04 billion in 2005, about 25 percent of total DTC ads run for all drugs.nberdtcstudy
The data show that 69 percent of cholesterol fighters have been advertised to consumers. In comparison, about 50 percent of the insomnia drugs have been advertised, 39 percent of gastrointestinal drugs have been advertised, and only about 23 percent of antiarthritic meds have been advertised over the sample period.

Read More News at
Phamalot.com

Sunday, May 16, 2010

Price Reduced in Patented Medicines in Spain.

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Spain Govt. took an important step, in order to avoid the financial crisis in Spain. Spain Govt. has reduced prices of many medicines and drugs, which also include many drugs those has been patented for up to 10 years. The main reason behind reducing the price is that, Govt is hoping of reducing what the public health system spend on prescription drugs as much as 23 percent. The saving which Govt. can make by taking these steps is roughly around 1.3 billion Euros or may be about $ 1.6 billion.

But this effort, does not extend to drug in the reference pricing system. But FarmaIndustria , the Industry trade group, criticized Govt. move and has warned the Govt. that it can cause thousands of job losses, and it can also make an effect on the research and development work going on. In another important step, Govt also decides that the price on generics has also been reduced by 25 percent.

These “are difficult and tough measures to take” but “are intended to strengthen the sustainability and balance of the National Health System,” says Trinidad Jimenez, Spain’s Minister for Health and Social Policy (that’s her in the photo). The ministry “has a deep respect for the pharmaceutical industry and understands their reaction, to defend their interests. (However), the pharmaceutical bill rises to nearly 15,000 million euros annually and the government becomes the largest customer in this sector…We demanded a lot to the industry and we believe that enough is enough.”

Saturday, May 15, 2010

FDA Backtracks On Glaxo Rotavirus Vaccine

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Two months after urging doctors to forego GlaxoSmithKline Rotarix vaccine, the FDA has done an about face and now agrees with one of its own panels, which last week decided the vaccine’s benefits outweigh its risks. The agency, you may recall, took its initial step after extraneous DNA fragments of PCV1 virus were found in two lots of Rotarix vaccine, which is used to combat rotavirus.
As the FDA acknowledged, porcine circovirus type 1, which is common among pigs, is not known to cause disease in animals or humans. Yet the FDA urged docs not to administer Rotarix until more research was completed. The FDA stopped short of a product recall, since there was no new info to contradict earlier evidence that Rotarix is safe and effective.
Instead, the FDA encouraged docs to administer Merck’s RotaTeq, which accounts for about three-quarters of rotavirus vaccines administered annually, while the agency geared up for the recent advisory meeting. But on the eve of the meeting, Merck found PCV1 and PCV2 in its RotaTeq vaccine , although the panel determined both vaccines offer more benefits than risks. Having left Glaxo at a disadvantage and, moreover, raising questions about whether agency officials were too hasty in addressing an unknown, the FDA is now trying to correct the record.

Friday, May 14, 2010

Google No Longer Allows Pharma an Exception to Its Ban on Paid Search Redirects

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Back in April 2009, It was suggested by John Mack that, FDA might go after pharma marketers for using paid search redirects in Google Adwords (see "FDA Concern May be the Use of 'Redirect' URLs"). Such ads use visible URLs such as "flaccidmember.com" but, when clicked, lead to viagra.com or cialis.com. Such an is considered to be "unbranded" and beyond FDA regulation. That is, it can say "Stay harder longer with this treatment for erectile dysfuntion" and lead directly to the branded website.

The problem with that strategy is that Google's Adword policy forbids the use of redirect URLs -- for most advertisers. It appears that Google was making an exception for the pharmaceutical industry (see "Redirect URLs in Adwords: Who Knew What When?").

But Google may have rescinded this exception. Tyler Ransburgh of What's Your Digital IQ Blog wrote about his problem using a redirect URL in a pharma ad. "I work in pharma," said Tyler, "I have an exception to the rule. Right? Well, I reached out to Google to get an answer on why I am getting caught in this web" (see "Google blocks Pharma paid search redirects")

When Tyler did reach out to Google, here's the reply he got:
"In response to advertiser and user feedback, and in an effort to provide relevant results and a high quality experience for our users, we have made the decision to no longer allow certain exceptions to our display URL policy. Please note that this amendment to our policy applies to all advertisers, regardless of previous exceptions for, or acceptance of, any campaigns. To provide a quality experience for our users and partners, the display URL policy will be strictly enforced."
I'd like to think that my blog posts were part of the "feedback" that Google considered.

But I wonder if the real reason for Google's policy turnaround is the "feedback" it got from the FDA when it proposed new ad formats for pharma paid search ads, which have already been used (in beta mode) by at least one pharma advertiser (see, for example, "Is Google the New FDA?")?

Perhaps FDA gave Google "permission" to have its pharma clients use the new ad format on condition that it no longer allow pharma advertisers an exception to its ban on paid search redirects.

It's a possible scenario. But  there are a lot of "back door" deals that the pharma industry and its agents make with FDA. If FDA's new transparency initiative is to mean anything, it should publish the transcripts of "private" meetings with the industry that result in changes in how it regulates the industry. For example, we know that Google met privately with FDA to discuss its new Adword format for drug ads -- Google referred to these meetings at the FDA public hearing. I would have loved to have been a fly on the wall during those discussions! Better than that, however, would be a published transcript -- even an edited transcript to protect proprietary information.

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FOLLOW-UP

Some  feedback are indicating that Google has NOT changed its policy regarding pharma's use of URL redirects in Adwords. See this Pharma and SEM Marketing Blog post by SEM Dave Anderson who indirectly received this comment from Google: "Our policy has not changed: pharmaceutical manufacturers continue to have an exception to allow a URL redirect, which is not currently recognized by our automated system." Which seems to directly contradict the comment received by Tyler Ransburgh from a Google Adword support team person who advised Tyler to "be assured that you have reached the appropriate AdWords support team for your AdWords related concern and I’ll be unable to escalate your issue further." Tyler, you see, had asked to speak to this person's supervisor and was rebuffed!

Pharma Marketing Meets Social Media: Can the Two Co-Habitate?

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Check out this SlideShare Presentation:
 

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