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.
