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 Super ..read more

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 original here - 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 ..read more

You can't make this stuff up! According to Huffington 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 Roc ..read more

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 opi ..read more

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 jit ..read more

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 ..read more

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 s ..read more

@QuintilesIMS teamed up with #PharmaForce to provide a framework for product launch assessment. The following is an excerpt. Download the entire report here. 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 ..read more

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 ef ..read more

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 anony ..read more