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Updated: 2017-03-25T15:39:36.735-04:00


How Many Adverse Event Reports Are Submitted to the FDA? Whatever the Answer, It's at an All-Time High!


I've been tracking the number of adverse event reports (AERs) submitted to the FDA over the years based on data supplied by the FDA here. The latest update of that data was made in November 2015 showing the number of AERs FDA received in the first quarter (Q1) of 2015.

If you assume that the submission rate seen in Q1 of 2015 remained constant throughout the year, you get the following trend chart based on FDA's summary data table:

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According this analysis, about 2.25 million AERs were submitted by healthcare professionals (HCPs) and consumers in 2015. An analysis by the Milwaukee Journal Sentinel and MedPage Today, however, yields drastically different numbers.

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Top Pharma Companies on Pinterest


According to ad agency AbelsonTaylor (AT), Pinterest has "enormous potential for healthcare marketing. Healthcare marketers should be engaging the outstanding attributes of Pinterest in their digital, e-commerce and social media marketing strategies and tactics" (read more here). AT suggests the following types of content are appropriate for pharma marketing via Pinterest:
  • Disease awareness (for clinicians and patients)
  • History of disease/treatment (for clinicians and patients)
  • Support groups/personal experiences (for consumers and patients)
  • Product launch market preparation measures (for clinicians)
  • Health association, foundation sponsorship (for clinicians and patients)
  • Corporate communications, research initiatives (for clinicians and investors)
I did a little research to find how many of the TOP 20 pharma companies - based on U.S. sales in 2015 - had Pinterest accounts and, if so, what types of content were published on these accounts. The results were a little surprising.

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FDA Cites TV Ads for "Compelling" "Attention-Grabbing" Distractions That Undermine Communication of Risks


According to an untitled letter FDA recently sent to Sanofi, all the fast-paced "grooving" going on in the “Mr. Groove” TV ad (here) for Toujeo makes it "difficult for consumers to adequately process and comprehend the risk information. The overall effect undermines the communication of the important risk information and thereby misleadingly minimizes the risks associated with the use of Toujeo." Moreover, "the presentation in the video is especially problematic from a public health perspective given the serious and potentially life-threatening risks associated with the drug."

"Mr. Groovr" dances while cooking. 
FDA complains about the multiple scene changes. Specifically, "Mr. Groove" dances while cooking, working in an office, mowing his lawn, picking tomatoes with his children, and walking his dog. "The presentation of these compelling and attention-grabbing visuals, all of which are unrelated to the risk message presented in the audio and on-screen SUPERS, in addition to the frequent scene changes and the other competing modalities such as the background music ["Let's Groove" by Earth, Wind & Fire], compete for the consumers’ attention,' says FDA.

FDA had a similar complaint regarding a TV ad (here) for Celgene's psoriasis treatment Otezla.

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Drugs for Older Americans Rose an Average of 15.5% in 2015 According to AARP Report


Retail prices for brand name prescription drugs widely used by older Americans rose by an average of 15.5% in 2015—almost 130 times faster than the 0.1% general inflation rate—according to a new AARP Public Policy Institute (PPI) report released today.

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AARP’s Rx Price Watch Report: Trends in Retail Prices of Brand Name Prescription Drugs Widely Used by Older Americans, 2006-2015, shows that the average annual cost for one brand name drug used on a chronic basis now exceeds $5,800. Five of the six drugs with the highest cumulative price increases over the study period were marketed by Valeant Pharmaceuticals. The retail price of Valeant's anti-anxiety drug, Ativan 1 mg tablets, increased by 2,873% between 2006 and 2015.
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Which companies raised prices the most? Crooked Valeant, of course, tops the list. But can you guess who is #2, #3, etc? Click "Read more" for the answer.

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