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The second half of Day One was all about what the FDA is doing to help spread the message of safety/efficacy -- with a particular focus on the issue of "safe use" of drugs.
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
Solid presentations from all my old buddies -- Ellen Frank (Director of Public Affairs/CDER), Mary Hitch (Senior Policy Advisor, Office of the Commissioner), Cathy McDermott (Director, Public Affairs, ORA) and Karen Feibus (OND, CDER).
They all presented their terrific work. All the more so considering the shoe-string budgets under which they operate.
But what does any of this have to do with DTC and under-served communities?
Let's just say it's tangential.
But (and not surprisingly) it really caught the attention of the committee. Good conversations, lots of kudos, some good ideas about how the FDA could do a better job in leading the "safe use" conversation ... but at the end of the day, and as interesting and important as it is ... it's mission creep.
Danger, Will Robinson, danger.
Day One closed with "Committee Discussion." Some nutty. Some really useful.
Some examples:
* A lot of comments on how FDA could do a better job on it's own communications efforts and a general call for the agency to get/allot more money for FDA communications efforts.
* The need for the agency to create an "Office of Minority Health"similar to the FDA's existing Office of Women's Health (often referred to as the "WFDA"). Good idea.
* A "Critical Path" program for health care communications/health literacy that would include the FDA, academia, other government entities (i.e., the FTC) and industry.
Yes, industry.
A potential hornet's nest for all the obvious reasons (hello Representative DeLauro), but a nifty idea.
* And some really wacko comments such as that the FDA should pre-review television ads "after they have been produced." And my other favorite, that DDMAC should pre-review "media placements."
At the end of the day, the issue the committee was supposed to address -- how DTC impacts under-served communities (socio-economic, minority, elderly) was answered in three simple words ... not enough information.
Onwards to Day Two and a stimulating conversation on 800 numbers for television ads.
To spice up my testimony, I enlisted help from Samuel Johnson, Juvenal, Woody Allen , and W. Edwards Deming.
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening?
In closing, I urged the committee to ponder this question posed by T.S. Eliot:
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in Information?
Is anybody listening?
Andreas Lord, of Eastern Research Group, presented a lit search of studies done relative to DTC issues and the "under-served" populations discussed in FDAAA.
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle.
Conclusion -- there isn't a lot of it and the studies that exist are "scattered and preliminary."
The recommendations of the committee -- more research.
Very helpful.
This hearing is beginning to be like treading water in treacle.
Only two people offered public comment. One was a woman talking about advertising for atypical antipsychotics. The other was me. The buzz among the press corps was "where's pharma?"
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
Committee chair Baruch Fischoff seemed somewhat perplexed at the general lack of industry comment (although he did specifically mention the importance of the docket). He then said a rather disturbing thing -- that industry should attend the meetings of the committee so they could "learn something that can help them make a buck."
I hope that someone at the FDA's Office of Advisory Committee Oversight reminds Dr. Fischoff of his role and the importance of choosing his words more carefully in the future.
Very pleased to announce the launch of "The Patient," the new benchmark journal for peer-reviewed authoritative and practical articles on the application of pharmacoeconomics and quality-of-life assessment to optimum drug therapy and health outcomes.
According to the publisher (Wolters Kluwer Health), The Patient is "an invaluable source of applied pharmacoeconomic original research and educational material for the healthcare decision maker. The journal is dedicated to the clear communication of complex pharmacoeconomic issues related to patient care and drug utilization."
Here's a link to the magazine's website
John Bridges (Johns Hopkins School of Public Health and Senior Fellow, Center for Medicine in the Public Interest) is the journal's lead editor.
(And, in the interest of full disclosure, I am on the editorial board.)
Here is a link to the magazine's website: http://thepatient.adisonline.com
We welcome this important new voice to the debate.
Raising premiums and squeezing providers...that will just put HMOs on the political hot seat again. Ultimately the health care decisions and dollars will have to flow doctors and patients and the real solution will be found in technologies based on underlying mechanisms of disease..
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washingtontimes.com/apps/pbcs.dll/article
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A few members of the New York State Assembly, led by Assemblyman Gottfried, the Chairman of the Assembly’s Health Committee, have introduced a bill that would require pharmaceutical detailers to obtain state licenses and abide by some peculiar rules.
For example: The bill would "establish a code of ethics for the practice of pharmaceutical detailing and collect information from registered pharmaceutical detailers relating to their communication with health care professionals, health care providers, or employees, agents or representatives of health care professionals or health care providers located in the state.”
What about the existing, rather stringent, government and industry regulations? Is the state going to legislate a floor or a ceiling? And as far as “collecting information,” that’s a pretty strong dose of Big Brother if you ask me and begs the question, “Whose next?”
The bill states that, “A pharmaceutical detailer shall not: engage in any deceptive or misleading marketing of a pharmaceutical product … For purposes of this section, it shall be considered an act of deceptive or misleading marketing to provide information regarding a use of a pharmaceutical product not approved by the federal food and drug administration.”
Even though the actual verbiage makes it sound as if pharmaceutical detailers shouldn’t be promoting investigational drugs (no argument there), I’m sure what Mr. Gottfried meant to address is off-label promotion. Perhaps he should have a chat with the folks at the FDA to, um, seek “guidance” on the matter. Or at least he should consult with an attorney familiar with the various and un-subtle legal precedents. (And what about the fact the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.)
Moving from the uninformed to the subjective, the bill states that all pharmaceutical detailers must, “be of good moral character and suitability.” According to whose standards? Elliot Spitzer?Quis custodiet ipsos custodes?
In the “Justification” section, the rational for this legislation states that, “Pharmaceutical companies are increasingly using detailers to go into doctors offices and market their prescription medicines.” But the fact is, for accuracy’s sake, that pharmaceutical detail forces are on the decline. Oops.
But what are facts when you have a research study done by that unbiased arbiter of truth and justice – Public Citizen. In discussing the need for a state-mandated code of ethics, the “Justification” continues, “A 2005 study conducted by Public Citizen and published in The Journal of Public Health Policy found that more than half of the drug makers participating in the 2002 America Psychiatric Association convention violated either the Association's own drug marketing guidelines or FDA rules.”
Further, “Congressman Henry Waxman of the House Committee on Government Reform found that "there has been a marked decline in enforcement actions taken against drug manufacturers by the FDA for illegally promoting their products since December 2001.” Perhaps a conversation with the FDA might enlighten Mr. Gottfried and his co-sponsors to the reality of the situation. (And a primer on federal preemption would also probably be useful.)
If this whole thing sounds familiar – that’s because it is. Remember the District of Columbia “Safe Rx Act of 2007? The devil is in the details – not the detailers.
For example: The bill would "establish a code of ethics for the practice of pharmaceutical detailing and collect information from registered pharmaceutical detailers relating to their communication with health care professionals, health care providers, or employees, agents or representatives of health care professionals or health care providers located in the state.”
What about the existing, rather stringent, government and industry regulations? Is the state going to legislate a floor or a ceiling? And as far as “collecting information,” that’s a pretty strong dose of Big Brother if you ask me and begs the question, “Whose next?”
The bill states that, “A pharmaceutical detailer shall not: engage in any deceptive or misleading marketing of a pharmaceutical product … For purposes of this section, it shall be considered an act of deceptive or misleading marketing to provide information regarding a use of a pharmaceutical product not approved by the federal food and drug administration.”
Even though the actual verbiage makes it sound as if pharmaceutical detailers shouldn’t be promoting investigational drugs (no argument there), I’m sure what Mr. Gottfried meant to address is off-label promotion. Perhaps he should have a chat with the folks at the FDA to, um, seek “guidance” on the matter. Or at least he should consult with an attorney familiar with the various and un-subtle legal precedents. (And what about the fact the FDA already regulates all educational efforts between physicians and sales reps? Inconvenient truths.)
Moving from the uninformed to the subjective, the bill states that all pharmaceutical detailers must, “be of good moral character and suitability.” According to whose standards? Elliot Spitzer?Quis custodiet ipsos custodes?
In the “Justification” section, the rational for this legislation states that, “Pharmaceutical companies are increasingly using detailers to go into doctors offices and market their prescription medicines.” But the fact is, for accuracy’s sake, that pharmaceutical detail forces are on the decline. Oops.
But what are facts when you have a research study done by that unbiased arbiter of truth and justice – Public Citizen. In discussing the need for a state-mandated code of ethics, the “Justification” continues, “A 2005 study conducted by Public Citizen and published in The Journal of Public Health Policy found that more than half of the drug makers participating in the 2002 America Psychiatric Association convention violated either the Association's own drug marketing guidelines or FDA rules.”
Further, “Congressman Henry Waxman of the House Committee on Government Reform found that "there has been a marked decline in enforcement actions taken against drug manufacturers by the FDA for illegally promoting their products since December 2001.” Perhaps a conversation with the FDA might enlighten Mr. Gottfried and his co-sponsors to the reality of the situation. (And a primer on federal preemption would also probably be useful.)
If this whole thing sounds familiar – that’s because it is. Remember the District of Columbia “Safe Rx Act of 2007? The devil is in the details – not the detailers.
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