Wednesday, November 01, 2017

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 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 of regulatory letters before they were issued and this policy change effectively hobbled the issuance of these letters by the FDA. Troy's delaying legacy continued after he resigned. (see “FDA DTC Review: The House that Troy Built”).

As you can see, the number of letters issued by the FDA rebounded sharply in 2009 and 2010 when Obama was president. It was as if the floodgates opened. After that, the number of letters slowly declined.

Unless the FDA issues a bunch of new letters in the final 2 months of 2017, the total count will be at an historic low. Obviously, this is in tune with the current administration’s focus on de-regulation.

Now we have Trump-appointed Dr. Scott Gottlieb as head of the FDA. What will his impact be on FDA enforcement activities?

Saturday, October 28, 2017

Dancing with Fentanyl: Insys Sales Reps Caught Rapping to Boost Sales

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$AP Rocky, which was played at the company’s national sales meeting that year...Court documents didn’t say which A$AP Rocky song was used in the video, but the indictment documents strongly suggested it could be the 2012 song “Fuckin’ Problems."

“Throughout the video, Company employees danced with a life size, 1600 mcg bottle of the Fentanyl Spray, the largest dosage of the drug available for sale in the United States,” the superseding indictment alleged. The video ended with the company’s vice president of sales removing the Fentanyl Spray costume, revealing his identity. The vice president of sales, Alec Burlakoff, was previously indicted back in December.

Thursday, October 26, 2017

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 cooperating with the U.S. Attorney’s investigation," company spokesman Robert Josephson said in an email. "We will continue to do so until this matter is resolved.”

Purdue is cast as the main villain in a wave of government lawsuits seeking to hold opioid makers and distributors responsible for an epidemic now killing thousands of people and costing the U.S. economy billions of dollars annually. Ten states and dozens of cities and counties have sued companies including Purdue, Endo International Plc, and Johnson & Johnson’s Janssen Pharmaceuticals, alleging that they triggered the epidemic by minimizing the addiction and overdose risks of painkillers such as OxyContin and Percocet.

Stamford, Connecticut-based Purdue invented many of the aggressive marketing techniques that made OxyContin a blockbuster drug and which government lawsuits now seek to frame as unlawful.

Purdue resolved a federal criminal prosecution in 2007. The company and three of its top executives pleaded guilty to “misbranding” OxyContin and collectively agreed to pay more than $630 million in civil and criminal penalties in one of the largest pharmaceutical settlements in U.S. history. The company specifically acknowledged that it trained its sales representatives to mislead physicians about opioid risks.
Relax. No one's going to jail!

Monday, October 09, 2017

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 furry felines were particularly "eerie"?

Thursday, September 28, 2017

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 company mention a brand name drug and its indication in the same communication.

I believe, therefore, that this email violates FDA regulations. I've passed this on via email to the FDA's BadAd program, which I am not sure still exists. Not being a healthcare professional, I don't have much standing with the FDA in any case.


So, what do you think? Violative or not?
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