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Feb29
Legal Experts Say FDA Is Making Off-Label Promotion Tougher, Rather Than Easier

Yesterday, Medical Marketing and Media published an analysis in its e-newsletterpills.jpeg focusing on the FDA’s new draft guidance on off-label promotion.  The article was interesting because it suggests that the proposed regulations make off-label promotion harder rather than easier.  In addition, the FDA is already following the guidance, even though it is not in final form.  According to the article:

“Sales reps could be effectively barred from circulating journal article reprints discussing off-label uses under FDA's draft guidance on ‘good reprint practices,’ and the agency considers the policy to be effective already, even in its draft form.”

Most importantly, the FDA is helping to clarify a raft of regulations developed by OIG that made pharma companies very uncertain about where they stood.  With the new guidance, the FDA is trying to take get ahead of the off-label regulatory race.

While the debate over this guidance is certainly interesting, there needs to be a similar effort focusing on off-label promotion in the context of online marketing.  Within pharmaceutical companies there is a big debate about what is permissible – and not – on the Web (especially as it relates to social media).  Right now, the focus is on context – i.e., is my promotional message off-label if it appears near content we don’t control?  

This is a tough question to answer.  Unfortunately, the FDA has yet to comprehensively address it. 

 


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The FDA and Its Progressive Lack of Citizen Protection

The Food and Drug Administration originated in its primitive form several decades ago to ensure the health and safety of the citizens of the United States. A book written by Upton Sinclair, while fictional, addressed the working conditions in a meat packaging company. While the author intended to address the effects of capitalism, the issue regarding food safety is what ultimately created the FDA.
However, their focus seems to have changed the past few decades, as they appear to have formed a pathological alliance with the pharmaceutical industry. An example is the large amounts of money the industry gives the FDA for various reasons- amounts so large that this accounts, according to some, for about half of the FDA’s income, upon information and belief. An example of funds received is due to the prescription drug user fee act, which began in 1992. Basically, the drug industry has been authorized and required to pay the FDA for faster approval of their pending medications. Results of this relationship between the drug industry and the FDA, one could posit, could be a contributing factor the progressive and recent approval of unsafe drugs and lack of regulation and monitoring of the pharmaceutical industry that the FDA is obligated to perform. Yet the FDA continues to validate what has been posited through their support from the drug industry, in ways that seem reciprocal, and as a consequence, have possibly neglected the health of the public as best as they should. However the growth of generics is about twice of branded meds annually, though, I believe.
Yet, the presumed intimacy between these two organizations, the FDA and the pharmaceutical industry, does in fact seem to continue to worsen- possibly due to the growth of generics. For example, and recently, a new proposal by the FDA has been introduced that would allow the pharmaceutical industry’s drug sales reps to discuss their products with prescribers off-label, which means that the FDA may allow and accept the industry with their approval to possibly creating harm to patients with this proposal due to uncertainty associated with unapproved uses of a drug promoted in this way. Yet the FDA claims that this proposal would enhance the education and knowledge of the prescriber by the pharmaceutical representative, and this is rather delusional, to say the least. Especially when one considers the high number of drugs that have been removed from the market or have been given a black box warning, which is possibly the equivalent of the drug being placed in a minimum security prison.
A prescriber, upon their own discretion, can in fact prescribe a drug off-label, but historically, however, representatives from the pharmaceutical industry have been prohibited from suggesting this type of activity. In fact, it is a federal offense for such reps to speak off-label about the drugs they promote, and more pharmaceutical companies are being penalized for this behavior in the past in the form of monetary settlements with the Department of Justice. The drug companies that have allowed such criminal offenses, through vicarious liability at times, perhaps, and rarely admit guilt as part of such settlements. Off-Label activities is only one of laws that have been fractured by pharmaceutical companies that have paid settlements.
This FDA protocol for drug reps. described and proposed is called, “Good Reprint Practices”, and would require pharmaceutical sales representatives to use what may not truly exist, which is truthful and authentic clinical trials, aseptic and sterile without bias, when and if they do speak off-label to prescribers. This in itself lacks etiology for such discussions by drug reps, as many clinical trials may be flawed due to the trials being possibly manipulated by the pharmaceutical companies of the meds involved in such trials, such as by a third party. Additional trial deception involves ghostwriting and invalid authors of such trials, and this is one of many concerns of this FDA protocol. These facts can be validated and have been discovered by others, so it appears the FDA did not take this into consideration.
Furthermore, this proposal is flawed in that most pharmaceutical reps lack clinical training and the ability for most drug representatives to analyze the unique statistical data regarding this issue with accuracy and meaning is unlikely, for the most part, I surmise. Remember that most drug reps have no medical or clinical training in any objective way, and, in my experience, have no interest in such training. So this seems to further complicate the idea of this off-label concept due to the ignorance of the reps of the complexities of these once reliable and dependable methods of proof. In addition, the relaxation of previous restrictions regarding off-label promotion could prove to be a catalyst for reps to embellish statements to prescribers for their own benefit in regards to their promoted meds. So, our previous safety association, the FDA, appears to be evolving into a possibly harmful association by suggesting such practices as this with deliberate intent and reckless disregard for public health, so it seems. Yet this situation of the FDA proposal mentioned appears to be of most benefit for the drug companies. It’s unbelievable this proposal ever came into existence, with the delusional fallacy that it would be of benefit to patient health, most likely. Furthermore, this may complicate existing patient medication errors, such as in the elderly or dosing for children, complicated by the fact that many are unable to understand label instructions on their med. So there are enough problems with prescribing, and adding this FDA proposal would just make the situation worse. We as citizens are no longer the concern of the FDA, one could conclude.
However, there is freedom of speech, but in the amendment may be restrictions in regards to public health, as speech should be accurate and objective. Perhaps another alternative would be to have clinically trained people discuss such issues with prescribers, instead of the drug reps, who, unlike those academically enriched, have the objective of increasing the market share of their promoted meds with no regard to the science behind these meds, in large part. Because historically, medications have in fact proven to be beneficial for other disease states other than what a certain med was initially indicated for upon approval. Regardless, awareness needs to happen by the citizens involving tactics that are possibly deceptive such as this and many more activities by the pharmaceutical industry that one could argue are in fact somewhat covert and tacit. As citizens, we have the right to insist of the pharmaceutical company to maintain focus on the interest of others besides themselves, which could be the case now with the FDA. And the health of the public is that interest what I believe we as citizens demand, and should be enforced than it appears to be presently.

“As far as we can discern, the sole purpose of existence is to kindle a light in the darkness of being.”
---- Carl Jung

Dan Abshear (author’s note: what has been written was based on information and belief)


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