Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks

Novo Nordisk Agrees to Pay Fine But Denies "Wrongdoing"; i.e., Sales Reps Obscured Victoza's Risks | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Novo Nordisk will pay $58.65 million to the Justice Department to resolve allegations that it instructed some of its sales representatives to share information with physicians that downplayed safety risks for Victoza, its type-2 diabetes medication.

 

The FDA approved Victoza in 2010, on the condition that the company implement a Risk Evaluation and Mitigation Strategy (REMS) to warn physicians about the potential risk of patients developing a rare cancer called medullary thyroid carcinoma. The drug now has a black-box warning.

 

The allegations against Novo include that managers instructed reps to “sandwich” the risk information between promotional messages in order to minimize that information. Reps also reportedly told doctors that the risk of cancer is only associated with mice and rats; that all diabetes drugs have boxed warnings and Victoza was no different; and that this type of cancer is “easy to treat” if a patient was diagnosed.

 

Because the reps gave doctors a misleading impression about the risks cited in the FDA-mandated REMS program, some physicians who prescribed Victoza were unaware of those risks, the Justice Department alleged. A government survey conducted in 2011 found that half of primary-care doctors were unaware of the cancer risks associated with Victoza.

 

In a statement, the drugmaker said it disagreed with the government's “legal conclusions” and denied wrongdoing. “We're pleased to have negotiated a resolution that allows the company to return its full attention to developing medicines that help improve the lives of patients,” Doug Langa, Novo Nordisk's president and EVP and head of North America operations, said in the statement.

 

Novo reported that Victoza – part of a class of drugs called GLP-1s, which includes Eli Lilly's Trulicity – brought in $3 billion in sales in 2016. In addition, the drugmaker has pursued new indications for the therapy. In 2015, a formulation of Victoza was approved as Saxenda, a treatment for weight loss. Earlier this year, the FDA approved Victoza as a treatment to lower the risk of cardiovascular events like heart attacks and strokes.

 

Novo spent $128 million on direct-to-consumer advertising for Victoza in 2016, according to Kantar Media.

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Whoops! Consumers Miss Risk Info in DTC Ads, Says Eye-Tracking Study

Whoops! Consumers Miss Risk Info in DTC Ads, Says Eye-Tracking Study | Pharmaguy's Insights Into Drug Industry News | Scoop.it

How much attention do people pay to the risk information for prescription drugs?

 

If you said “not much,” you would be correct.

 

A recent study found that, while about 80 percent of those viewing risk information for a fictitious allergy drug claimed to have read at least half or more of the warnings, an eye-tracking tool found they actually read little to none of the cautionary material on a product website. Of 29 people, eight did not read any of the side effect disclosure, some of which was supposedly unique to this medicine.

 

In general, the participants — all of whom had been diagnosed with a seasonal allergy and reported suffering symptoms during the past year — had a very low recall level. Of 12 side effects mentioned, on average, the participants correctly recalled just one. And nearly 45 percent did not recall any risks, while 17 percent recalled just one risk

Pharma Guy's insight:

Meanwhile, #FDA May Believe TV Direst-to-Consumer Drug Ads Overstate Risks; http://sco.lt/4t338z 

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Will #Pharma Get on FDA's "Less is More" DTC Risk Information Bandwagon?

Will #Pharma Get on FDA's "Less is More" DTC Risk Information Bandwagon? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

“Less is More” is being applied to health care communication. The FDA is overcoming the DTC Fear Factor and casting aside unnecessary risk information with the intent to drive superior patient comprehension. The FDA has issued draft guidelines that require less, not more, risk information in the Consumer Brief Summary portion of DTC print ads. PharmaGuy provides a comprehensive (and as always, entertaining) review of the proposed guidelines in his February Newsletter.


But the FDA is not using the editing pen wily-nilly. Knowledge born of research, is taking the edge off of their DTC Fear Factor. Upcoming research includes a study on the risk information presented in television ads. The objective is to see whether listing only the most actionable risks leads to better comprehension than the usual mind-numbing laundry list.


Certainly the FDA has reason to fear getting the level of risk information wrong. AsDaniel Carpenter, a Harvard professor who studies the FDA posits in a Health Affairs article, the FDA is driven by it’s “desire to safeguard its reputation for protecting the public’s health.” The FDA’s “Less is More” approach certainly has its critics. Public Citizen criticized the FDA for its proposed August ’14 guidelines on how pharmaceutical companies should present risk information to physicians


This new “Less is More” approach to risk information demonstrates that the FDA is willing to undergo reputational risk to do the right thing for patients by presenting the information in a way patients can understand and act on. There is substantive evidence that links lack of patient understanding with negative health outcomes.”


So what is the likelihood of pharmaceutical review committees embracing the “Less is More” philosophy regarding risk information? Certainly the new review FDA guidelines will help, but as anybody who has sat through a review committee meeting can tell you, there is wide latitude in how FDA guidelines are interpreted. Many opt for the most conservative approach.

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FDA Plans Another DTC TV Ad Study That is Sheer Torture!

FDA Plans Another DTC TV Ad Study That is Sheer Torture! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The FDA plans to to study the "Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads" (see Federal register Notice). 

"Generally," says FDA, "it has been argued that first exposure to an ad results in attention, second exposure affects learning of the advertised message, and third and subsequent exposures reinforce the learning effects of the second exposure. To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads."

To fill that void, FDA's Office of Prescription Drug Promotion OPDP) plans to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads.

The experimental design calls for volunteers to be randomly assigned to view a prescription drug ad one, three, or six times as part of "clutter reels" embedded in a 42 minute TV program. 

My concept of a volunteer participating in this study is shown on the image above/left.

Guess how many "volunteers" FDA plans to torture in this experiment. Click here to find out.

Pharma Guy's insight:


In this 3.5-minute audio snippetAdrienne E. Faerber, PhD, and David H. Kreling, PhD, talk about the key results of their content analysis of claims made by TV direct-to-consumer (DTC) drug ads and advise consumers how to recognize potentially misleading or outright false claims -- including celebrity endorsements -- made by these ads.

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Joel Finkle's curator insight, November 13, 2014 11:28 AM

I had to scoop this article just for the image: FDA to test effects of direct-to-consumer advertising.

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That Eye-Tracking Risk Research Study is Flawed, Says @Richmeyer. Marketers Should Pay It Little Attention.

That Eye-Tracking Risk Research Study is Flawed, Says @Richmeyer. Marketers Should Pay It Little Attention. | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A recent study in the Journal of Risk Research suggested that patients, when visiting pharma websites, don’t read drug risk information (read “Whoops! Consumers Miss Risk Info in DTC Ads, Says Eye-Tracking Study”; http://sco.lt/7WY049).  This study is flawed in many ways and DTC marketers should not read too much into it.

As any DTC marketer knows, or should know, the “safety information” page is always among the top pages on drug websites.  Patients want to understand what to expect from their Rx’s both before and after filling an Rx.

The Journal of Risk research would have us believe other wide, but there are significant flaws in the study... more

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FDA Official Says Detailed Drug Risks in TV Ads Are a "Waste of Time"

FDA Official Says Detailed Drug Risks in TV Ads Are a "Waste of Time" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Long lists of scary prescription drug side effects at the end of television advertisements are a waste of time for patients, one of the U.S.’s top drug regulators said.


“When they give the adverse events, or adverse reactions, it’s this litany of complaints” -- death, or “‘Don’t use if you have MAE1,’” said Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration.


“What patient knows what MAE1 is?” Pazdur said. “It’s just a waste of time.”

Pazdur’s remarks come after the FDA last year began studying whether long lists of side effects in TV ads may cause viewers to overlook the most dangerous aspects of the medicine. An agency document about the study said it might be best to list only the most serious side effects and cover any lesser risks with a statement saying there are other potential harms.


Pazdur spoke at a Friends of Cancer Research meeting Tuesday in Washington.

Pharma Guy's insight:


I haven't heard the ad that mentions "MAE1" but this sounds like a straw man argument - using an unusual case to diss all ads. In any case, you might be interested in reading this Pharma Marketing News article: "Do TV DTC Ads Overstate Rx Drug Risks?": http://bit.ly/pmn130202 

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FDA Prohibits Package Inserts in DTC Print Ads & Recommends New "Consumer Brief Summary"

FDA Prohibits Package Inserts in DTC Print Ads & Recommends New "Consumer Brief Summary" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

On February 4, 2004, the FDA issued long-awaited draft guidance documents designed to improve communications to consumers and health care practitioners about health conditions and medical products. One document was titled “Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements.”

“Our new regulatory guidance,” said Mark B. McClellan, M.D., Ph.D., FDA Commissioner at the time, “provides new direction to sponsors on how to provide higher-quality health information to the public, based on recent evidence on what works and what doesn't in drug promotion” (read "FDA Draft Guidance for Print DTCA: Less than Feared").

But now even NEWER evidence - and complaints from the pharma industry - forced the FDA to issue a "revised draft guidance" titled "Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Human Prescription Drugs," which you can find here (Docket No. FDA-2004-D-0500).

Released on February 9, 2015, this revision was ELEVEN years in the making. Compared to that, the four years FDA took to issue draft social media guidelines was lightening fast.

The guidelines address the requirement under provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which require that an advertisement for a prescription drug to disclose each side effect, warning, precaution, and contraindication from the labeling. This is referred to as the "brief summary requirement."

So what's new in the guidelines? Read more...

Pharma Guy's insight:


One consumer-friendly format that FDA recommended is a "Prescription Drug Facts Box," which is based on a format used for OTC products. In 2009, a Dartmouth Study concluded that a "Fact Box" on risk/benefit is good for consumers. The study included a mock up of a Fact Box for Lunesta (shown below), a popular sleep aid drug that was heavily advertised to consumers at that time.

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Number of Drug Recalls Surges - Especially Ones with Serious AEs!

Number of Drug Recalls Surges - Especially Ones with Serious AEs! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.


Pharmaceutical companies occasionally need to recall—that is to say, remove—products from the market. While the reasons for product recalls vary, they are commonly related to packaging defects, contamination of a product, improper testing of a product, or inherent safety problems which could lead a product to harm a patient.


Those recalls are classified according to a three-tier system administered by FDA:


  • Class I Recall - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
  • Class II Recall - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III Recall - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.


Pharma Guy's insight:


Meanwhile, FDA's new off-label reprint distribution guidance states: "FDA does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling, and is distributed by a firm in the form of a reprint or digital copy of a published study." For more on that, read 

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe

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