Farewell Pharma Friends! Beware of the PharmaGovernment Complex!
It ' s my 71st birthday and I decided it ' s a good time for me to move on to a new role. Unbelievable, right? John " PharmaGuy " Mack is seventy-one years old!Also unbelievable is that I am shuttering my pharmaceutical online publishing business after 16 years of continuous operation! There will be no more Pharma Industry News Update emails, no more PharmaGuy Insights on Scoop.it, and no new Pharma Marketing Blog posts. There will still be tweets from @pharmaguy, but eventually even that will end.Although one door has closed, another door has opened for me as a Newtown Township, PA Supervisor. Yes, I am now a “pol...
Source: Pharma Marketing Blog - February 6, 2018 Category: Pharmaceuticals Source Type: blogs
Why Has There Been a Drop in FDA Enforcement Activity?
That's one question on the mind of EyeOnFDA author Mark Senak of FleishmanHillard's Washington, D.C. office. Senak plotted the number of"Action Letters," which are Warning Letters to drug company CEOs plus so-called"untitled" letters addressed to underlings - usually regulatory officers. I copies his chart - find the originalhere - and highlighted the years in which a Democrat (D; blue) or Republican (R; red) was in the White House.The FDA's Chief Counsel between August 2001, and November, 2004 was Bush-appointed Daniel E. Troy. Soon after being appointed, Troy instituted a legal review of r...
Source: Pharma Marketing Blog - November 1, 2017 Category: Pharmaceuticals Tags: FDA untitled letters warning letters Source Type: blogs
Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales
You can ' t make this stuff up!According toHuffington Post, " Pharmaceutical sales representatives selling an opioid-based drug 50 times more powerful than heroin filmed a company-made rap video in which they danced with a giant bottle of their deadly fentanyl spray, a federal grand jury alleged in an indictment unsealed this week (for more about that, read "Founder of Insys Indicted for Bribing Docs to Illegally Prescribe Fentanyl. Lock Him Up!" )." The grand jury alleged that ' prominent ' sales reps at Insys Therapeutics Inc. appeared in a 2015 music video that used a song by rapper A$AP Rocky, which was played at the c...
Source: Pharma Marketing Blog - October 28, 2017 Category: Pharmaceuticals Tags: Fentanyl Insys Opioids Sales and Sales Reps Source Type: blogs
Purdue's Opioid Marketing is Target of a Federal Criminal Probe
As reported by Bloomberg:Federal prosecutors in Connecticut began a criminal investigation into Purdue Pharma Inc. ’s marketing of the controversial opioid painkiller OxyContin.U.S. Attorney Deirdre Daly is gathering documents about Purdue ’s claim that OxyContin provides 12 hours of pain relief. A Los Angeles Times investigation, published last year, found that Purdue ignored evidence showing the drug’s effects failed to last that long in some patients, increasing the risk of withdrawal, abuse and addiction. “Purdue is committed to being part of the solution to our nation’s opioid crisis and has been c...
Source: Pharma Marketing Blog - October 26, 2017 Category: Pharmaceuticals Tags: Opioids Purdue Pharma Source Type: blogs
Is The End of Animated Characters in Drug Ads Neigh?
Merck has decided to dump its furry white vs black feline critters in its new direct-to-consumer advertising campaign for Belsomra saying that “the original ad served its purpose " ; namely, breaking through the TV drug ad clutter to be noticed. Read the story below.I have to ask if this is a trend now that each brand using mascots has already " broken through " AND the FDA is beginning to look more closely at the use of animated characters in ads (read "FDA Will Apply the ' Uncanny Valley ' Hypothesis to Test the ' Eeriness ' of Animated Characters in Drug Ads" ). Or is it just Merck who got the jitters because those fu...
Source: Pharma Marketing Blog - October 9, 2017 Category: Pharmaceuticals Tags: Belsomra FDA Mascots Merck Sleep Aid Drugs Source Type: blogs
Is The End of Animated Characters in Drug Ads Neigh!
Merck has decided to dump its furry white vs black feline critters in its new direct-to-consumer advertising campaign for Belsomra saying that “the original ad served its purpose " ; namely, breaking through the TV drug ad clutter to be noticed. Read the story below.I have to ask if this is a trend now that each brand using mascots has already " broken through " AND the FDA is beginning to look more closely at the use of animated characters in ads (read "FDA Will Apply the ' Uncanny Valley ' Hypothesis to Test the ' Eeriness ' of Animated Characters in Drug Ads" ). Or is it just Merck who got the jitters because those fu...
Source: Pharma Marketing Blog - October 9, 2017 Category: Pharmaceuticals Tags: Belsomra FDA Mascots Merck Sleep Aid Drugs Source Type: blogs
Does This Email Message from KVK Tech Violate FDA Regulations?
Today, I received an email message from KVK Tech - a generic drug manufacturer located in my my hometown of Newtown, PA - regarding a gift to Stanford ' s Department of Bariatric and Minimally Invasive Surgery (see below; ignore that the email has the wrong date on it - you can ' t expect a drug company to have good copy editors, can you?). It talks about obesity in the U.S.At the end of the email, in the " About KVK Tech " section, it mentions that it manufactures and distributes Lomaira, which is a drug to treat obesity. Unfortunately, KVK Tech does not mention the Important Safety Information (ISI) whenever a drug compa...
Source: Pharma Marketing Blog - September 28, 2017 Category: Pharmaceuticals Tags: FDA KVK Tech Obesity drugs regulations Source Type: blogs
Is FDA Most Science-Based and Less patient Centric Now that Gottlieb is in Charge?
Last October, FDA caved in to patients lobbying on behalf of Sarepta ' s Duchenne drug Exondys 51 despite the fact that there was little scientific evidence that it was effective (read "FDA Succumbs to Industry-Sponsored Patient Power& Accelerates Approval of Sarepta ' s Duchenne Drug" ).Now, another company -- PTC Therapeutics -- is seeking approval for a competing drug and the FDA warned in a briefing document that it the company should not depend on the same tactics to get its drug approved. Will paid patient lobbyists sway FDA just like they did for Sarepta? Or is the FDA now more science-based that Gottlieb i...
Source: Pharma Marketing Blog - September 27, 2017 Category: Pharmaceuticals Tags: Duchenne FDA Source Type: blogs
Specialty Brand Sales Excel Today, But What About Tomorrow?
@QuintilesIMS teamed up with #PharmaForce to provide a framework for product launch assessment. The following is an excerpt. Download the entire reporthere.The chart below shows the total amount of revenue associated with launch brands in the year that they launch. " From 2000-2006, " notes QuintilesIMS, " we see that somewhere between $3 billion and $5 billion were spent on launch brands in the first 12 months in which they were launched. These are your traditional, big primary care type of products. "Further quoting from the report:" The launch figures dropped down in 2007-2010, and this is where you see launch brands ge...
Source: Pharma Marketing Blog - August 25, 2017 Category: Pharmaceuticals Tags: Launch specialty drugs Source Type: blogs
PhRMA May Be Shooting Itself in the Foot by Criticizing FDA DTC Studies
As reported by RAPS (here), the Pharmaceutical Research and Manufacturers of America (PhRMA) is"harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.""FDA has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health. Within the last year, the Agency has increased such efforts at an exp...
Source: Pharma Marketing Blog - August 17, 2017 Category: Pharmaceuticals Tags: DTC Advertising FDA PhRMA Study Source Type: blogs
" Fake Advertising " : Allergan Should Be Red in the Face for Using " Before & After " Images in Rhofade & Kybella Ads
Allergan is again resorting to side-by-side"before and after ” images in a drug ad to prove that Rhofade - its new drug for the treatment of redness of the face, aka rosacea - works. This is the same technique the company used to promote Kybella for double chin syndrome.In the Kybella case, I analyzed the figures and suspected foul play; i.e., the after image was just a retouched version of the before image. That ad, however, claimed they were “unretouched photos” (read"Kybella Double Chin TV Ad: Are the BEFORE& AFTER Photos REALLY Unretouched as Claimed?").Despite some anonymous commentator to m...
Source: Pharma Marketing Blog - August 8, 2017 Category: Pharmaceuticals Tags: Allergan Fake Advertising Kybella Rhofade rosacea Source Type: blogs
Is FDA Too Slow to Approve New Drugs?
Back in March, 2017, President Trump"called on the Food and Drug Administration to speed the approval of drugs to treat life-threatening diseases, deriding the agency ’s current process as'slow and burdensome' ”(here).According to Dr. Michael Carome, Director, Public Citizen ’s Health Research Group, president Trump’s claims that the U.S. Food and Drug Administration’s approval process for medical products is “slow and burdensome” and “keeps too many advances … from reaching those in need,” reflect complete ignorance about the FDA’s current regulatory schemes for ensuring that medications...
Source: Pharma Marketing Blog - July 5, 2017 Category: Pharmaceuticals Tags: Drug Approval FDA Pence Right to Try Source Type: blogs
The Forgotten eHealth Code of Ethics
Recently, I was sorry to see that theeHealth Code of Ethics, which I helped create back in 2000, was not included in the list of references to an article about trust and credibility of web-based health information. According to the Code, individuals need to be able to judge for themselves the quality of the health information they find on the Internet. Sites should disclose what sources the site or content provider has used, with references or links to those sources.Any research or effort designed to improve the quality of health information on the Internet must build upon the work already done by the creators of the inter...
Source: Pharma Marketing Blog - June 27, 2017 Category: Pharmaceuticals Tags: eHealth Ethics Source Type: blogs
Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its DTC Advertising Principles & Code on Interactions with Healthcare Professionals. Why Not?
In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance thePhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.Despite the thundering unanimity of the PhRMA Board, several current board members are NOTsignatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guide...
Source: Pharma Marketing Blog - June 12, 2017 Category: Pharmaceuticals Tags: Alkermes DTC Advertising Opioids PhRMA PhRMA Guidelines Physician Marketing Source Type: blogs
Funny, Witty, Snarky Pharmaguy Memes About Pharma
The original, pre-internet definition of a meme is, “an element of a culture on system of behavior that may be considered to be passed from one individual to another by non-genetic means, especially imitation”.Today, the “element of culture” is often an image or photo that has spread through social media or texting and which has been modified to include overlaid text. At least, that is how my son defines meme.Over the years I have created numerous memes that I hope will be copied and passed on from one pharmaceutical marketer to another. This PowerPoint presentation includes many of my favorite memes and some insig...
Source: Pharma Marketing Blog - June 5, 2017 Category: Pharmaceuticals Tags: Meme snarky Source Type: blogs
