Sunday, August 31, 2014

More Very Imformative Comments from Readers!

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!!
Anonymous
at 5:00 PM
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
Anonymous
at 11:36 AM
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
Anonymous
at 10:28 AM
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

1 comment:

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