Articles Posted in Marketing

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Interesting developments in online social media and drug companies, in the past week. As you know, the FDA has been soliciting requests about how to manage online social media for drug and device manufacturers. This is clearly a lot for drug companies to deal with, and here are some things they should wrap their minds around:

  1. Sanofi-Aventis VOICES Facebook Page: This drug company, maker of the cancer drug Taxotere, learned first-hand the downside of having a Facebook site that allows interaction with customers. That downside is that customers interact. One Taxotere user posted complaints to the FB page about the drug, only to have her post removed. Undeterred, she sent more posts, opened other Facebook accounts, sent more posts, had friends send posts, and just generally assaulted the Sanofi-Aventis stronghold. Finally, Sanofi-Aventis changed their information and stated on the FB page:

    This page is not intended as a forum for discussing sanofi-aventis’ or other companies’ products. As such, Postings that contain product discussions will be removed by sanofi-aventis.

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To follow up on our March 2, 2010 post BigPharma Goes All “Social Media” is a website that features all comments submitted to the FDA on the social networking question. A somewhat more readable version (though, less complete) is at www.fdasm.com.

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AZ%20Social%20Media-03-02-10%29.JPGUp until now, online social networking has been treated mostly as a plaything for some pharmaceutical manufacturers. They will post a few updates on Twitter, maybe start a Facebook page or post a YouTube video or two, but I have not seen much indication that the companies have really bought in, much less that they “get it” (though, some like AstraZeneca may be playing it safe while the FDA works out the regulation aspect).
Eye on FDA has a good summary of what’s happened to get us to this point. Initially, the FDA was more concerned with the content of pharmaceutical and medical device manufacturers’ messages. However, last year the FDA realized that there is only so many contraindications you can fit in 140 characters. So, in September 2009, they took the proactive step of setting a meeting (which BigPharma interestingly did not attend), and encouraging comments (open through last month). The hope is that they will be able to draft some sort of guidelines, so everyone knows where the line is.

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Here are this week’s stories:

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Profit-02-15-10%29.JPGIn Foster Care Children and Off-Label Drug Use I discussed the use of drugs, particularly psychotropics, to medicate children. In Who Do The Drug Companies Cater To? I talked about doctors (one in particular) who, by all accounts, clearly overprescribed medications, including Seroquel and clozapine.

Now, an article from the Anchorage Daily News reports that the Law Project for Psychiatric Rights filed a federal lawsuit against over a dozen Alaskan psychiatrists, stating that the doctors “unnecessarily drugged children and committed Medicare fraud.”

The article points out that children on Medicare are four times as likely to be put on antipsychotic medication as children who have private insurance. 90% of children seeing psychiatrists are put on medication, while less than 10% of those medications are FDA approved for children.

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Here are the stories we’re following:

  • Levaquin: NJ.com reports that Levaquin manufacturer Johnson & Johnson may have paid millions in kickbacks to a large pharmacy for prescriptions to nursing home patients. The complaint was filed by the U.S. Attorney in Boston.
  • Acetaminophen: An article published in the medical journal Thorax ScienceDaily reports that there may be a direct link between use of acetaminophen during pregnancy and child asthma.
  • Twombly/Iqbal Statistics: The Federal Judicial Center has collected preliminary data on motions to dismiss before and after Twombly and Iqbal (hat tip: The Civil Procedure and Federal Courts Blog).
  • Prempro: Bloomberg discusses Judge Ackerman’s reduction of the Connie Barton punitive damages verdict (by 93%, from $75 million to $5.6 million) and added $1.2 million in interest to the jury’s compensatory damages verdict of $3.7 million.

Happy Monday!

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The FDA’s Center for Devices and Radiological Health (CDRH—you can follow them on Twitter) will hold a free public meeting to address concerns and discuss strengthening of the 510(k) process. The agenda includes:

  • Issues related to predicate devices;
  • Issues related to new technologies and scientific evidence;
  • Issues related to practices CDRH has adopted in response to the high volume of 510(k) submissions; and
  • Issues related to postmarket surveillance and new information about marketed devices.

The FDA receives over 3,000 510(k) submissions every year. “A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA.” After much backlash last year about FDA scientist/employee complaints about corruption, safety problems, conflicts of interest and budgeting, the Institute of Medicine (IOM) was called on to comprehensively study (to the tune of $1.3 million) the 510(k) process. That study is expected to be completed in March 2011, but this meeting is a companion to that study.
Conference Details:

  • Time/Location: 8:00 a.m. to 5:30 p.m.; Hilton Washington DC North/Gaithersburg; 620 Perry Parkway; Gaithersburg, Maryland 20877
  • Live webcast

Related documents:

This meeting is another good step the administration has taken to put patient safety first, and to rigorously watch over the medical device regulatory process.

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Instead of doing our usual Monday Drug Blog Round-Up yesterday, we opted for a fuller post on the recent plaintiffs’ pain pump victory in Oregon. For more on that story, see the Oregonian. So, today we’ll bring you the links to the stories we’re following:

  • Direct-to-Consumer Advertising: FiercePharma lists the top ten drugs for percentage of web-based traffic from DTC ads. YAZ is seventh, even “better” than Viagra.
  • Radiation Therapy Malpractice: Pat Malone reports on the dangers of technology, training and procedures in radiation therapy: “Scott Jerome-Parks suffered terrible radiation burns to his neck, and lingered for two years in agony before dying, because he received a seven-fold overdose in the radiation that was supposed to treat his tongue cancer, on three separate occasions.”
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Some noteworthy news items to start your week:

  • Tylenol: Tylenol drug recall expanded to include other Johnson & Johnson/McNeil products (Motrin, Benadryl, Rolaids, Simply Sleep, St. Joseph). See the manufacturer’s press release.
  • Radiation: Philadelphia Veterans Administration acknowledges that incorrect dosages of radiation were given to 114 veterans for prostate cancer. See the Legal Blog of Shrager, Spivey & Sachs.
  • BPA: FDA to change labeling for bisphenol-A. It has “some concern about the potential effects of BPA on the brain, behavior and prostate gland of fetuses, infants and children.” See The New York Times.

  • FDA Warning Letters: Publication by Sean P. Wajert, James M. Beck, and Vincent A. Gallo on the “Reduced Legal Oversight For FDA Warning Letters Amplifies Compliance And Liability Risks.” See the Washington Legal Foundation.
  • Faked Drug Research: Federal charges filed against a doctor who allegedly faked research for painkillers, including Vioxx and Celebrex. He received money and other presents from Pfizer. See Yahoo! Finance.

Happy Monday!

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Here are some of the stories we’re following this week:

  • Janumet: Shearlings Got Plowed reports that the FDA is revising the label for Janumet to warn about pancreatitis. A link to the FDA’s prescribing information is here
  • Seroquel: Tom Lamb reports on the difficulties that plaintiffs are facing in these cases, of late. It seems that the odds are against us and the situation is grim—a good time for a reversal