Obama administration tells FDA to let compounders copy FDA approved/available drug
earlier in Oct, I posted the above article on this blog…
now a article has been published http://vitals.nbcnews.com/_news/2012/10/30/14810526-pharmacy-made-pregnancy-drug-under-scrutiny-after-meningitis-outbreak
from the article:
the FDA issued what many observers saw as an unusual statement, saying that “to support access to this important drug, at this time and under this unique situation,” it would not take enforcement action against pharmacies that properly and safely made similar versions of the drug.
In the past, the FDA had sent warning letters or pursued other action against pharmacies when it could show they were mass producing copies of FDA-approved drugs.
Insurers covering the private market, meanwhile, have a range of rules around the use of Makena. UnitedHealthcare, one of the nation’s largest insurers, says in a policy document that it “continues to support the use of compounded, preservative-free” versions of the drug through “local and national… pharmacies.” However, it also reimburses doctors who choose to prescribe Makena.
Cigna covers Makena, as well as the compounded drugs, according to an April 2012 policy document.
Still, some physicians may feel pressure to prescribe the cheaper versions even when the insurer says it will pay for the brand name drug.
Last week, KV filed a complaint with the U.S. International Trade Commission alleging that the New England center and other pharmacies use active ingredients imported from Chinese factories that are not routinely inspected by the FDA.
Imagine raw ingredients from China … not inspected by the FDA… made in facilities not inspected by the FDA and after recent revelation about pharmacies that do sterile compounding… using questionable procedures. Insurance companies and many state Medicaid dept – with the support of the FDA – will only pay for this product… which according to the law is a ILLEGAL PRODUCT.
I didn’t hear any outcries when Humibid LA went generic/OTC and a company stepped in and go the rights to market it under Mucinex… at a much higher price … Didn’t hear much of a when Colchicine went through a similar process and was back on the market as Colcrys at a much higher price.
Are we on a slippery slope of third party payers strongly encouraging/mandating a product that is being produced ILLEGALLY… where is the stopping point??
Filed under: General Problems
HOLD on one freakin’ minute, Peon. It is NOT the ‘Obama’ administration that is saying they will not prosecute compounding pharmacies for making a drug.
President Obama complained as loudly as anyone else that corporations were to be considered as individuals, which to me, implies that Baxter, KV, Hospira, CatamaranRx, any manner of pharmacy-related companies can act wherever and however as individuals with freedom under the law to make as much money as they can to the full extent of the law.
The precedent for ethical treatment standards has long-been established and consequently slipping long before the ‘Obama’ administration, with congressional arranged ‘drug junkets’ to Canada, consideration of those drugs generally regarded as safe and effective grandfathering, drugs not unlike Makena, recalling quinidine, papaverine, quinine for leg cramps, injectable indomethacin, and later ibuprofen injection. Many Catholic hospitals refuse to provide the birth control medication their female patients took prior to admission, but early in that time of particular restriction there seemed no problem in continuing to fill orders for yohimbine as administered prior to admission to the hospital.
Apparently each case is handled individually. Do you recall the last time filling Qualaquin prescription when the patient paid cash?
My point, do the research and contribute as a professional expert to the decision-making process instead of allowing paid lobbyists and non-pharmacy lawyers, stockbrokers, MBA Admin., economics, political science and other non-health related, non-science logical careers make decisions that impact us as pharmacists and our patients.
Makena is FDA approved. It would seem logical that if anyone else made the drug and sold it that this would be illegal. But, the Obama administration is saying they will not prosecute compounding pharmacies for the making the drug. A clear violation of the law! I have noticed that the Obama administration has frequently violated laws. They just do whatever they want to do with a total disregard for the law. Now, we have the fiasco over the compounding pharmacy and the fungus. Looks like the drug market is becoming like the Wild West where anything goes and there is little if any oversight over the manufacturing of the drugs.
Chains definitely have it easy right now. It’s similar to how it’s illegal for independents to get together and agree on accepting/denying an insurance plane… But a single chain has the same effect!
The FDA is not doing its job to regulate these drugs. Pharmaceutical companies are doing whatever they want because they have the money to pay the government off. Somebody needs to step up to stop this mess. Thank you Pharmacist Steve for all your insight!