What is characterized as "greed" here is a good first step, but, it refers to only a stratum of greed layered on top of the baseline enrichment--what are already very high profit margins that can be obtained from mixing drugs from scratch from chemicals that may have no warranties on their certificates' stated attributes--a reality that probably has not been disclosed to parties involved in compounded drug transactions, including payers. It may not be characterized as "greed" if you only mark-up for the pharmacy--but is it is okay to expose patients to untested drugs if you keep the margins under the radar? Does it become greed only when you mark-up in a manner that trips the payer alarms, after building in added profits for the pharmacy, the doctors, the business partners, etc? Then the non-FDA approved drugs stand out like neon on a black and white photocopy. The recent case highlighting creams sold for thousands revealed that the pharmacy was charging less than 100.00. If on Finally a Compounder Says It: Greed Is Not Good!!
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Anonymous
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at 5:00 PM
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If you look across the industry over decades, you will notice the “would-be” NDA/ANDA/BLA holders’ organized market entry campaigns that pop-up simultaneously across the nation—bioidentical hormones, chelation therapy, nicotine lollipops, topical pain creams take I (local anesthetics) and topical pain creams take II (centrally acting agents). These national “launches” have taken on new meaning after the Supreme Court decision, with pharmacies nudged by the “would-be” NDA/ANDA/BLA and patent holders to hire individual or shared sales forces to “detail” specific products to any willing doctor, or medical practice, or hospital, or alternative care setting. It is a truly brilliant model for escaping and/or circumventing public health oversight—spread the manufacturing across 10,000 pharmacies, and, separated into so many pieces it has very little chance of raising regulatory scrutiny, by FDA, states, or other. And if people are being harmed in small numbers here and there from on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 11:36 AM
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The sooner payers (and pharmacists and doctors) recognize that they are the "pass throughs" in a vastly decentralized, sub-standard drug industry, the better. The "would be" NDA/ANDA holders are the entities filing patents, selling chemicals and formulas, and marketing and promotional materials, without warranty, escaping layers and layers of legal and regulatory scrutiny under the imprimatur of the practice of medicine and pharmacy. File a patent, write a recipe, source the chemicals, call in the marketers, drop it into 10,000 pharmacies or doctors' offices nationwide and "game-on." on Compounding Group Taps Former Express Scripts Official
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Anonymous
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at 10:28 AM
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I could not access the entire article, but, if you look at historical warning letters over time, you will see the FDA has used the same enforcement options prior to 1997 FDAMA, and under Section 503A, and under Section 503A in regions where it held with advertising restrictions severed after the SC ruling, and where 503A was not in force post SC ruling, under prior guidance. The new law resolves ambiguity--nothing new with respect to enforcement options? on FDA Releases Slew of Warnings to Compounding Pharmacies
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Sunday, August 31, 2014
More Very Imformative Comments from Readers!
Finally a Compounder Says It: Greed Is Not Good!!
The Compounder Forum: Greed Is Not Good Read It here
Saturday, August 30, 2014
Compounding Group Taps Former Express Scripts Official
The United Compounding Network, which was launched last month to negotiate with payers and pharmacy benefit
managers on reimbursement for compounded drugs, named its key leaders, including a former high-level manager from
Express Scripts, a PBM which has drawn the ire of compounders for recently restricting its coverage of such products.
UCN Wednesday (Aug. 27) named David Ott as president and Diana Baumohl as vice president of business development.
Ott held executive positions with Anthem/ WellPoint Health Networks and worked most recently as founder and
principal consultant of Innova Health Solutions, UCN said. Baumohl has worked more than 20 years in the healthcare
industry, including “a variety of executive management positions at Express Scripts, Inc. (ESI),” UCN said in a press
release. “As VP of Business Development, her understanding of the market from both sides will guide UCN’s efforts in
working with compounding pharmacies and payors.”
The network will include state-regulated compounding pharmacies that, based on accreditation and quality standards,
meet a higher bar. The network plans to negotiate reimbursement levels and provide other services, such as standardized
claims billing.
In July Express Scripts started blocking compounding coverage of more than 1,000 bulk ingredients because of increased
prices. It is among other PBMs and payers making recent coverage changes for compounded drugs. The separate Patients and
Physicians for Rx Access — which includes participation from the International Academy of Compounding Pharmacists,
physicians and patients — also recently formed to fight the coverage restrictions. — Alaina Busch McBournie
quoted from here
Wow!! Here are some of the Reasons Prescribers and Patients Should Beware of Compounded Medications including Compounded Pain and Scar Creams!!
There are numerous theoretical basic science, animal and clinical science safety signals related to any proposed multi-ingredient transdermal formulation intended for the far reaching indications for which the compounded creams are marketed-- from scar removal to the treatment of cardiovascular circulatory problems. There are also very serious safety signals related to prior compounded cream deaths.
The pervasively marketed, patent-holding compounded pain creams simply have not been investigated and vetted prior to marketing--they are experimental. But you would not know that from their promotion.
More Great Comments From Readers!! Must Read!!
at 6:23 PM
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"...GMP requirements" above should read "...GMP requirement exemptions" on The New Federal Compounding Law by Mike Corrado
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Anonymous
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at 5:56 PM
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Under 503A, compounded drugs that meet stipulated conditions are exempt from 3 provisions of the FFDCA, and, they may still be held to other provisions for which they are not exempt. Guidance available here: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf If you read most recent FDA warning letters, making drugs under unsanitary conditions can result in adulteration charges, wether or not conditions are being met for new drug, labeling, and GMP requirements. Bird feathers fungus and filth should not make their way into FDA-approved or compounded pharmaceuticals, regardless of whether or not they are intended for sterile administration. on The New Federal Compounding Law by Mike Corrado
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Anonymous
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at 5:54 PM
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Non-sterile compounds are covered under the original 503A, which was substantially weakened by the Supreme Court ruling but which may have been corrected under DQSA, with clarifications regarding false and misleading claims. But I agree--non-sterile compounds can be just as dangerous, and are currently heavily marketed through sophisticated programs. Check out this patent for "compounded transdermal pain management," including 30-40% by weight of ketamine, intended for mixture with other potent and potentially toxic substances, including clonidine, and local anesthetics implicated in previous compounded drug deaths and for which FDA has taken prior enforcement actions: https://www.google.com/patents/US20130085171?dq=ininventor:%22Charles+D.+HODGE%22&hl=en&sa=X&ei=SkkCVKXEA43BggSp7IHACw&ved=0CFAQ6AEwBw on Second Question of the Day August 30, 2014 Did Congress make a huge mistake by not including nonsterile compounded medications in the DQSA because they may pose just as big a risk as sterile compounded medications?
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U.S. congress debates doping in horse racing
August 30, 2014
Leaders from the horse racing industry spoke before the United States congress to discuss whether the sport needs federal oversight to ban doping. Legislation in the U.S. could be followed by similar bills passed in Europe.
Congress considered legislation regulating horse racing in the 1980’s. Last month, federal authorities arrested members of a Mexican cartel using racehorses bred and trained in the United States for laundering drug money.
Sen. of has proposed legislation to ban race-day medication in horse racing. Udall's bill would ban substances such as , a diuretic that is considered a performance-enhancing drug.
continue to read here
Congress considered legislation regulating horse racing in the 1980’s. Last month, federal authorities arrested members of a Mexican cartel using racehorses bred and trained in the United States for laundering drug money.
Sen. of has proposed legislation to ban race-day medication in horse racing. Udall's bill would ban substances such as , a diuretic that is considered a performance-enhancing drug.
continue to read here
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