Yesterday, September 23 2008 FDA finally launched a long awaited crackdown against companies marketing prescription medications without government approval.
The NEW™ Institute involvement with the skin cream containing papain, derived from the tropical papaya plant, provided evidence that manufacturers were selling it without federal validation of their safety and efficacy.
The cream is being touted by about a dozen of manufacturers for treatment of chronic (non-healing) skin ulcers from diabetes and other causes.
As of today, there is no single approved version of such cream in a "business" worth about $50 million a year.
The adverse reporting noted that frequently the cream was of no help to patients and caused life-threatening allergiс reactions.
Companies making this unapproved cream have till November 24 to file for FDA approval or cease production in lieu of FDA seizures and other legal actions.
Be Well!
Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts
Wednesday, September 24, 2008
Monday, February 19, 2007
NEW™ Prescription for Pharma Marketing.
Since the beginning of my healthcarING© career in 1993, in addition to my full time clinical practice (since 1975), I have served as the Managing Editor of Managed Care Medicine, Editorial Board Member of the US Pharmacist, Advisory Board Member, Center for Consumer Healthcare Information, Board Member of The Formulary & Managed Care Information Exchange (M.C.I.X.), Editorial Board Member, The Medical Reporter, Editorial Board Member, Managed Healthcare Journal, Information Security Magazine, Editorial Board Member, ADVANCE for Health Information Executives, to name a few.In addition, I’ve served on numerous Advisory-Industry-Executive Boards: National Managed Health Care Congress, (NMHCC/IT), American College of Managed Care Medicine, American Board of Managed Care Medicine, Pharmacy Partnership/CMA Foundation, State of California Task Force on Health Plans and Managed Care, The IPA Association of America (TIPAA), US Congress, Ministry of Health of Russian Federation, Association of Medical Directors of Information Systems (AMDIS), American Society of Consulting Pharmacists, the Institute for Alternative Futures, and the National Pharmaceutical Council among many others.
As a private Consultant first, and later as the Chief Medical Information Officer, Superior Consultant Company, I had the privilege of working with the top 50 pharmaceutical, biotechnology & medical device companies in the world.
Given my expertise and track record, that I can categorically state that the days of detail and/or clinical liaison person as well as any and all financial incentives for physicians, pharmacists, nurses, and allied health providers are over. Similarly, the days of TV ads bombardment and hiring of models for the trade shows are over and should be over (please see "The Prescription Project ). 
The NEW ™-old prescription for pharma-biotech-device marketing has been around since September, 1995 when I was invited by the FDA to present my expert opinion on the subject of Pharmaceutical Marketing and Information Exchange in Managed Care Environments.
In my testimony, from October, 1995, I presented the key incentives and disincentives of implementation of then emerging information technologies by the pharmaceutical industry. (see the US FDA Archive). Here are the “nuts & bolts” of my model proposed to the FDA in 1995:
“…The pharmaceutical companies should be moving from drug providers to total health solution providers including an expanded self-definition and developing their identity as a shared vision. Customers and partners who share an expansive vision of health help pharmaceutical companies to identify and create new market opportunities. This enhanced feedback mechanism will move pharmaceutical companies along the path of development into markets that are being formed by new information systems that organize the population with ever-increasing regularity...
...The pharmaceutical companies will use this information technology for mass markets, where one size fits all, moving towards customized health solutions when one size fits one. In this growth, the competencies are naturally growing around disease management. The ever-evolving definition of disease management by customers, including patients and their families, as well as professional providers, both physicians, pharmacies and the allied health professionals, will expand the competencies of pharmaceutical companies...
...This evolution leads to an expanded marketplace that reaches beyond the products into services, including many that are non medical, but nevertheless effect health. The health care consumers ( patients with specific diseases) who interactively help shape the new services, will lead pharmaceutical companies to pay far greater attention to post-market information. For this information to develop, pharmaceutical companies will form new partnerships with information companies...
...The pharmaceutical companies that succeed in such partnerships will be those that are open to participatory information sharing and development. Increasingly, the customers and partners of the pharmaceutical company that succeed in redefining themselves will look to these health solution providers for leadership. Also, creating such a partnership will help deal with the concept of the “fantasy of certainty”©...
...One strategy is to use feedback to help consumers play a more important role. The successful application of this strategy also supports shifting consumers from possible recipients of care to empowered proactive self-care participants…”
In summary, I challenged the FDA to “…regulate less and guide more and become a source of information for all”. During my service on the FDA General Scientific Advisory Board (Consumer Representative), from 1998 to 2002 I continued to advocate and promote the use of the Health Care Value (HCV©) which I originally introduced 1995, based on evidence- supported, repeatable, verifiable outcomes. I also continued to champion the cause of informed health consumer-concerned provider partnerships (PPP) enabled by the ethical and socially-
responsible manufacturers.
“…The pharmaceutical companies should be moving from drug providers to total health solution providers including an expanded self-definition and developing their identity as a shared vision. Customers and partners who share an expansive vision of health help pharmaceutical companies to identify and create new market opportunities. This enhanced feedback mechanism will move pharmaceutical companies along the path of development into markets that are being formed by new information systems that organize the population with ever-increasing regularity...
...The pharmaceutical companies will use this information technology for mass markets, where one size fits all, moving towards customized health solutions when one size fits one. In this growth, the competencies are naturally growing around disease management. The ever-evolving definition of disease management by customers, including patients and their families, as well as professional providers, both physicians, pharmacies and the allied health professionals, will expand the competencies of pharmaceutical companies...
...This evolution leads to an expanded marketplace that reaches beyond the products into services, including many that are non medical, but nevertheless effect health. The health care consumers ( patients with specific diseases) who interactively help shape the new services, will lead pharmaceutical companies to pay far greater attention to post-market information. For this information to develop, pharmaceutical companies will form new partnerships with information companies...
...The pharmaceutical companies that succeed in such partnerships will be those that are open to participatory information sharing and development. Increasingly, the customers and partners of the pharmaceutical company that succeed in redefining themselves will look to these health solution providers for leadership. Also, creating such a partnership will help deal with the concept of the “fantasy of certainty”©...
...One strategy is to use feedback to help consumers play a more important role. The successful application of this strategy also supports shifting consumers from possible recipients of care to empowered proactive self-care participants…”
In summary, I challenged the FDA to “…regulate less and guide more and become a source of information for all”. During my service on the FDA General Scientific Advisory Board (Consumer Representative), from 1998 to 2002 I continued to advocate and promote the use of the Health Care Value (HCV©) which I originally introduced 1995, based on evidence- supported, repeatable, verifiable outcomes. I also continued to champion the cause of informed health consumer-concerned provider partnerships (PPP) enabled by the ethical and socially-
responsible manufacturers.HCV© is a near-quantitative time-tested measure, accepted by the FDA and a number of forward-thinking, proactive pharmaceutical, biotechnology and medical device companies trying to operate with quality and ethics in the industry's "quality vacuum" created by the ever-mounting requirements for quality performance reporting in the absence of government standards or industry consensus.
Let's now forward to 2007: The US FDA has "dropped the ball" and the overwhelming majority of the pharmaceutical and biotechnology companies are still engaged in the “traditional” marketing methodology of directly and/or indirectly "incentivising" physicians, pharmacists and allied health professionals to increase their respective market share of newer, as well as “me 2” drugs and drug delivery systems.
Instead of educating the providers, empowering the health consumers and empower health consumer-provider partnerships based on HCV© the majority of manufacturers are engaged in a barrage of “no-indications” TV ads devised to create demand “from below” by creating paranoia among the health consumers and overwhelming the providers.
With its corporate values of being science-based, competing intensely and winning, working in teams, creating value for patients, trust & respect for each other, ensuring quality, collaboration, communication and being ethical and accountable, Amgen seems to be "ahead of the pack". Sounds great, but is it factual?
Let's now forward to 2007: The US FDA has "dropped the ball" and the overwhelming majority of the pharmaceutical and biotechnology companies are still engaged in the “traditional” marketing methodology of directly and/or indirectly "incentivising" physicians, pharmacists and allied health professionals to increase their respective market share of newer, as well as “me 2” drugs and drug delivery systems.
Instead of educating the providers, empowering the health consumers and empower health consumer-provider partnerships based on HCV© the majority of manufacturers are engaged in a barrage of “no-indications” TV ads devised to create demand “from below” by creating paranoia among the health consumers and overwhelming the providers.
With its corporate values of being science-based, competing intensely and winning, working in teams, creating value for patients, trust & respect for each other, ensuring quality, collaboration, communication and being ethical and accountable, Amgen seems to be "ahead of the pack". Sounds great, but is it factual?
Hence, I am introducing the Pharmaceutical Ethical Marketing & Manufacturing (PEMM©) Index, which is a ratio of the R&D budget to the Marketing & Administration budget by the company across all product lines (% of, or actual expenditures). Currently, the industry-wide PEMM© index is around 0.39. This index will serve as rough, but sorely needed, guide for health consumers and providers.
Since Americans are already subsidizing every manufacturers world-wide sales (as evident by significantly lower prices for the same drugs in Canada, Mexico, Bahamas, Europe, etc.), it is totally reasonable on the part of consumers and providers of health care to expect a PEMM© index of every ethical and carING© manufacturer to be at least a 1.0, and preferably higher. I hereby invite and challenge Amgen and all other manufacturers to make their PEMM© index information public--I am confident Amgen's index will be much higher than industry average.
In the meantime, here is an unsolicited NEW™ prescription for pharmaceutical, biotechnology and medical device manufacturers: deliver verifiable, evidence-based health care value (HCV©), partner with & educate your customers (consumers & providers of health care, not the PBM managers or HMO executives), and foster patient-provider partnerships---keep your PEMM© index high, and your sales will follow!
Be Well!
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