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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Doctor with Ties to Purdue #Pharma Helped Develop Canadian Opioid-Prescribing Guidelines

Doctor with Ties to Purdue #Pharma Helped Develop Canadian Opioid-Prescribing Guidelines | Pharmaguy's Insights Into Drug Industry News |

It's a bad day when the federal health minister wants to check your work. But that's what's happening to a McMaster University committee that was assigned to develop new opioid-prescribing guidelines for Canada's doctors.


The rules from Health Canada were clear when it awarded the half-million-dollar grant to McMaster's Michael G. DeGroote National Pain Centre in 2015: No one with any ties to big pharma could be allowed to vote on the final draft of the guidelines, which were intended to help doctors make difficult decisions about opioid use for chronic non-cancer pain.


As the hand-picked experts sat around the table arguing about when doctors should prescribe the dangerous pills, everyone in the room assumed everyone else in the room was free of industry ties.


But the truth was revealed earlier this month, when the guidelines were finally published.


One of the members of the voting committee had ties to drug companies that sell opioids, including Purdue Pharma (Canada), which manufactured OxyContin, one of the most notorious prescription opioid drugs.


The guidelines on opioid-prescribing practices in Canada are now under review after it was revealed that a member of the voting committee had received financial compensation from Purdue Pharma Canada, as well as other companies that market such medications.


Dr. Nav Persaud, another member of the voting committee, said he was shocked when he learned the news.


"We were asked to complete conflict-of-interest declaration forms twice," Persaud said. "My understanding was that the declarations were going to be reviewed, and anyone with financial conflicts of interest was going to be excluded from the voting panel."


New guidelines for prescribing opioids encourage doctors to put down the pad

Yet somehow Dr. Sol Stern, a family physician based in Oakville, Ont., was allowed to become a member of the voting committee, despite disclosing he had received financial compensation from Purdue and other companies that market opioids for giving talks and serving on company advisory boards.


The entire episode shines a light on an aspect of Canada's health-care system that is widely accepted, but rarely discussed — the vast financial relationships between doctors, hospitals and the pharmaceutical industry.


Nearly half of the pain specialists on the broader expert advisory committee (six of its 13 members) also disclosed ties to drug companies that make opioid pills.

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FDA's Social Media Guidances Provide Little That's New, Says Coalition for Healthcare Communication

Indeed, at the Drug Information Association Annual Meeting held last week in San Diego, Abrams noted that he expected minimal use of space-limited media because of the agency’s requirements on risk information. Cooke wrote that OPDP’s call for risk information that includes the most serious risks associated with the product, as well as all boxed warnings, makes it “difficult to imagine a product that has fatal or life-threatening risk, contraindications or boxed warnings that could be contained within the space-limited context of a Tweet, which has a 140-character limitation.” For example, he cited one product’s boxed warning, which alone contains 692 characters.

This approach “would limit the availability of space-limited communications to the small subset of prescription products whose risk and benefit information” meet the agency’s requirements, Cooke said, adding that the framework set forth by the draft guidance “seems more amenable to the participation of products with limited risks and short benefit statements.” He told the Coalition that the agency “could have suggested some approved abbreviations to help companies meet the requirements in a limited space – such as using ‘risks incl death’ instead of ‘risks include’ and listing all possible inclusions –but it chose not to.”

In an e-mail to Bloomberg BNA June 17, James N. Czaban, chairman of the FDA Practice Group at Wiley Rein LLP, said that the risk/benefit guidance “is actually very limited in scope” because it does not address many other types of online activity. He also told BNA that “The idea that FDA would allow a black box warning to be condensed for use in the format of Google Sitelinks or even Twitter is quite surprising given existing promotional limitations on black box products, and the length and seriousness of such warnings for many drugs,” Czaban told BNA. “Will any company risk such an approach from a liability perspective, even if it could meet the space limitations?”

Czaban said that “the bottom line is that FDA’s guidance leaves many questions unanswered, and its examples are of limited utility.”

Pharma Guy's insight:

Here's how I believe pharma can create a compliant tweet INCLUDES a 692-character boxed warning: A Type of Rx Drug Tweet FDA Did Not Consider in its Recent Guidance

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Tweet #Risks as Well as #Benefits, #FDA Tells #Pharma

Tweet #Risks as Well as #Benefits, #FDA Tells #Pharma | Pharmaguy's Insights Into Drug Industry News |
“Don’t use Viagra if your heart isn’t healthy enough for sex.” After that warning, Pfizer Inc. will have just 81 letters left to tweet about the benefits of its erectile dysfunction drug, say U.S. regulators.

Drug and device makers who send social media messages on services like Twitter will be required to include the risks and benefits of their products when they do so, the Food and Drug Administration proposed today in two draft guidelines. That means packing that information inside the strict 140-character limit of the social media site from Twitter Inc. (TWTR)

Drugmakers have been awaiting the guidelines since the FDA held a publicmeeting in 2009 to gather input on social media promotion. Companies have avoided tweeting about products as they wait on the FDA, Lori Leskin, a partner at the law firm Kaye Scholer LLP in New York, said in an interview.

“I think this is clear enough guidance you’ll start seeing more tweets,” Leskin said. “It’s the more significant drugs that do have black box warnings, that do have more significant risk, that are used in limited populations that this won’t be appropriate for.”

Pharma Guy's insight:

We'll start seeing tweets... Really? I don't think so! Lawyers... what do they know? Read my take on this: 

FDA to Pharma: Forget About Tweets! But You Can Host Discussion Forums About Branded Rx Products, Sorta, & Kinda Correct Misinformation

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Adventures of PhRMA Intern. Episode 2: The Reminder Ad

Adventures of PhRMA Intern. Episode 2: The Reminder Ad | Pharmaguy's Insights Into Drug Industry News |

Principle #13 of  the final version of PhRMA’s Guiding Principles on Direct to Consumer Advertising about Prescription Medicines, which applies to both TV and print DTC ads, states:

"DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised."

Reminder ads are usually 30-second TV commercials or print ads that mention a drug's name without stating the health conditions for which the drug is approved and without listing the major risks associated with the drug. These ads are perfectly legal from a regulatory point of view. Signatories of PhRMA’s DTC Guiding Principles, however, are prohibited from using this type of ad.  

Back in 2006, when PhRMA Intern was active, she noticed an ad that she thought violated Principle #13. Here's the story...

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The FDA Social Media Guidances May Not Change Anything: Senak Explains

The FDA Social Media Guidances May Not Change Anything: Senak Explains | Pharmaguy's Insights Into Drug Industry News |
After a five-year wait, the FDA this week released guidelines for how drug and device makers should deal with social media. One provides a blueprint for correcting misinformation on websites run by others, while the second guidance discusses the use of Twitter. We spoke with Mark Senak, a senior vice president and partner at the FleishmanHillard public relations firm that works closely with drug makers and who also writes the Eye On FDA blog, about what the guidances may – or may not - change.

Pharmalot: And what about the other guidance, which refers to using Twitter?

Senak: Using Twitter for specific product communications prior to the guidance was problematic because there were so many unknowns. But now it’s problematic because of what we know.

Pharmalot: What do you mean?

Senak: In general, the manufacturer must present risk information in the same venue as any discussion of a product. In characters placed in a limited venue, people didn’t know how to cram all of that into 140 characters, particularly after the banishment of a one-click rule in 2009, [my emphasis] when you couldn’t use a link to take you elsewhere to read the info.

So people avoided Twitter, because it wasn’t known how to satisfy requirements. Looking at the guidance and the example of how to develop a Tweet, it’s still so constricted that I think product-specific communication by Twitter is still problematic. Again, I think it’s a situation where not much has changed.

Pharma Guy's insight:

I take issue with Senak's statement that the "one-click rule" was "banished" by the FDA in 2009. He's referring to the famous 14 letters FDA sent to major drug companies on April 2, 2009 (read "Ramifications of FDA Regulatory Actions").

Here's what I wrote in November 2007 - nearly one and one-half years prior to when Senak says FDA "banished" the one-click rule (read: The "One-Click Rule": Rant or No Rant?):

The "one-click rule" is no rule at all and is merely a platitude online pharmaceutical marketers spout to trick us into believing that they obey "rules." Since I spend a lot of time documenting how pharma marketers violate this "rule" repeatedly, I thought I would write a comment to the authors of a document that advised pharma about the "rule." Here it is. You decide if it is a "rant" or not.

In the paper, the authors make frequent reference to the so-called "one-click rule" regarding access to fair balance information on the Internet.

If you search Google on "one-click rule FDA" you won't find any references to this rule that the FDA has made, but you will find my post "Girl from Google." (posted in November 2005).

That's because, in that post, I discuss how the so-called "one-click rule" was used to justify Google Adwords (aka, "BAdwords") that violate FDA guidelines -- these ads mention the brand name and indication, but do NOT include any fair balance as is required by FDA. (NOTE: THE FDA'S 14 LETTERS PRECISELY TARGETED THESE KINDS OF ADS IN APRIL, 2009, MORE THAN 2 YEARS AFTER I POINTED OUT THAT THESE ADS VIOLATED FDA REGULATIONS!).

One person from a pharmaceutical company, perhaps playing the devil's advocate, contended that these "BAdword" ads may pass muster with the FDA because the package insert or brief summary is "one or two clicks away." His argument was that without specific guidance from the FDA, no one knows what is correct in this case.

It is a shame that the FDA does not have any guidance for the industry as far as Internet advertising is concerned. This means that marketers can use lack of guidance as a defense for sneaking in ads that push the envelope. What are the chances that the FDA would ever notice (BUT THEY DID!). These ads are fleeting, here today, gone tomorrow!


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