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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FDA's Reprint Distribution Guidelines are "Counterintuitive" & "Indecent"

FDA's Reprint Distribution Guidelines are "Counterintuitive" & "Indecent" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The consumer watchdog group Public Citizen garnered significant attention this week when it raised an alarm against an FDA proposal that would enable pharmaceutical companies to distribute new drug safety data from clinical trials directly to doctors, prior to FDA review for a potential label change. Its concern is that this proposal would allow pharmaceutical companies to publicize medications as "more safe" than what the FDA approval process had previously revealed.


As noted in a Reuters article covering Public Citizen's protest, "Last June the Food and Drug Administration proposed allowing the distribution of new risk information about approved drugs, saying that a drug's safety profile "evolves" as exposure to the product increases." And yet the article states, "Companies would not be allowed to distribute literature about newly identified risks or information that shows an already identified risk is more serious than stated on the label. Such information would need to be reviewed by the FDA and potentially included in the label."


Huh? Why would FDA acknowledge that as new information emerges it changes the safety profile of a drug (which it does -- see Table 1), but that those data should only be conveyed if drugs are presenting as more safe than expected? Isn't that totally counter-intuitive. More safe is like an added bonus, a surprise treat in the cereal box. Less safe? As in new, unanticipated side effects, isn't that what people really need to know about? And quickly? Isn't the FDA's primary goal to ensure the safety of the public at large? How could keeping dangerous side effects a secret be a good thing for anyone?



Pharma Guy's insight:


I believe the FDA is tipping the balance in favor of commercial "free speech' and away from drug safety. For more on that read and a review of the FDA guidelines, read this Pharma Marketing News Article:  "More FDA Guidance on Distribution of Reprints." 


Topics include (partial list):

  • Some Off-Label Litigation History
  • A String of Off-Label Guidances
  • WLF vs FDA
  • Criteria of Approved Off-Label Studies
  • Sidney Wolfe Cries Foul!


Download the full text PDF file here:
www.pharma-mkting.com/news/pmnews1308-article02.pdf

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Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance

Public Citizen Accuses FDA of a Coverup Re Off-Label Reprints Distribution Guidance | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Public Citizen has told HHS secretary Sylvia Burwell that FDA should withdraw its recent draft guidance on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products — Recommended Practices because it would allow pharmaceutical companies to tell physicians that marketed drugs could be less risky than FDA-approved labels say they are.


In an October 22 letter to Burwell, the group's founder and senior advisor, Sidney M. Wolfe wrote that  the guidance would allow pharmaceutical salespeople to “inform physicians of the purportedly lower risks by distributing peer-reviewed articles assessing a drug's risks and discussing with doctors the information about the ‘lower' risks, without the FDA reviewing the articles, analyzing the data, or approving distribution of that information.”


His letter also complained about FDA's decision to withhold over 1,700 public comments on the draft guidance, suggesting that it is trying to cover-up criticism of the proposal.


“Of the 1,781 comments submitted on the proposal, only one comment has been posted on the government agency's Web site in the 58 days since the comment period closed,” Wolfe wrote, adding that on 10/15 it requested under the Freedom of Information Act the release of the comments.


Pharma Guy's insight:


Sidney Wolfe Cries Foul!

In a JAMA Internal Medicine viewpoint article pub- lished on August 15, 2014, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Re- search Group, argues that the draft guidance “suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products” and would “let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approv- ed labeling.”

Does Wolfe have a case? 


For more about that, read More FDA Guidance on Distribution of Reprints

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Two Pradaxa Post-Marketing Safety Studies Reach Different Conclusions: Which One Will Boehringer Distribute to Docs?

Two Pradaxa Post-Marketing Safety Studies Reach Different Conclusions: Which One Will Boehringer Distribute to Docs? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Boehringer's anti-clotting drug Pradaxa is marketed as better and safer than warfarin, the generic and much cheaper alternative. The ads specifically mention that no frequent blood tests are needed to monitor the safety and effectiveness of Pradaxa, whereas such tests are necessary for warfarin.

This makes easier to sell Pradaxa to cardiologists and family practitioners who can pass on these obvious safety advantages to patients who need to carefully weigh benefits vs. risks of these powerful drugs. 

But this task is made much more difficult when there are two post-marketing approval safety studies that come to two different conclusions. Considering that news of the studies have been released on the same day (today), the stage is set for battling it out in public.

One study of Medicare patients -- by the FDA -- was published online inCirculation on October 30, 2014. A press release dated today (November 3, 2014; here) claimed that it "further reinforces the favorable benefit/risk profile of PRADAXA."

Another, independent study of Medicare patients, titled "Dabigatran Associated with Higher Incidence of Major Bleeding vs. Warfarin," was published online November 3, 2014 in JAMA Internal Medicine (and embargoed until 3 pm Central). That study claimed that the "incidence of major bleeding was 9 percent for the dabigatran (Pradaxa) group and 5.9 percent for the warfarin group."

How do two different studies seemingly reach two different conclusions based on the same population? And which study will Boehringer (BI) distribute to docs via its sales reps?

Pharma Guy's insight:


Recall that BI was sanctioned for violating Clauses 2, 9.1, 3.2, 22.1 and 22.2 of the ABPI Code of Practice in 2011. The case originated from a complaint by a "general practitioner" filed with the Prescription Medicines Code of Practice Authority (PMCPA), which oversees the ABPI Code.

The PMCPA "was very concerned about the content of the press release and the briefing material for spokespersons. The [PMCPA] Panel considered that these would in effect encourage members of the public to ask their health professional to prescribe a specific prescription only medicine. The Panel was concerned about the lack of information in a consumer press release relating to side effects."

The news articles written based on BI press materials made some great marketing statements that BI could never make, such as referring to Pradaxa as a "super pill" and a "revolutionary drug." The stories also dissed the competition (warfarin) by referring to it as "rat poison." BI press materials did not refer to warfarin as rat poison and "otherwise made no disparaging remarks about the medicine," said PMCPA, which had no evidence about how warfarin had been described by Boehringer Ingelheim’s spokespersons or at any press conference. Therefore, no breach of the Code was ruled in that regard.

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

FDA's "Off-Label Risk Reduction" Approach to Reprint Distribution is "Misguided," Says Sidney Wolfe | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In June, the FDA issued a THIRD draft guidance document regarding reprint distribution by pharmaceutic companies. This new guidance describes FDA’s recommendations for distributing reprints that convey "new risk information" for approved drugs.


In a JAMA Internal Medicine viewpoint article published today, Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, argues that the draft guidance "suggests that the agency has now tilted toward protecting industry's commercial speech and away from protecting patients from the risks of prescription drugs and biological products" and would "let the pharmaceutical industry essentially circumvent drug labeling rules and tell doctors that its products have fewer risks than those described in the FDA-approved labeling."

Does Wolfe have a case?

Pharma Guy's insight:


Take my little poll at the end of this post:


Do you agree that new risk information should only be conveyed in the drug's labeling, not via reprints?

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