Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
11/27/13 - The license suspension stands until at least January for a South Lyon pharmacy accused of mass-producing drugs for hospitals and clinics in violation of its license. The hearing was held yesterday before Administrative Law Judge David Cohen in Detroit, who ruled that the license suspensions of Specialty Medicine Compounding Pharmacy and its owner, Kenny Walkup Jr., will remain in place until at least January when a full hearing will take place. Attorney General Bill Schuette ordered the suspension after several of the pharmacy’s products at Henry Ford Hospital in Detroit were found to contain fungus. Tuesday’s hearing went late into the evening and hours of testimony centered on the whether or not the facility was sterile and whether Walkup and the pharmacy were licensed to mix products in bulk. The Detroit Free Press reports that inspectors for the state and the FDA testified that the pharmacy was not following proper procedures to ensure products were sterile. Walkup is said to have been acting as a drug manufacturer by distributing large amounts of medication to various hospitals and clinics even though the pharmacy is currently only licensed to fill individual prescriptions. He had applied for a license to manufacture drugs in October 2012, but that application was denied. Walkup’s attorney maintains that regulations allow pharmacists with that type of license to provide the service if it is less than 5% of the pharmacy’s business. A final decision will be made by the Michigan Pharmacy Disciplinary Subcommittee, which will be based on the judge’s recommendation. (JM)
Tacrolimus is a relative new drug to the veterinary world. It comes from a class of medications called "calcineurin inhibitors," and it is used most frequent for treating keratoconjunctivitis sicca (also known as KCS or dry-eye). Less commonly this medicine is used topically to treat for allergies (atopy) and for some of the autoimmune skin diseases (discoid lupus erythematosus, pemphigus erythematosus, etc.). In human medicine this medication is used orally for similar conditions at massively higher dosages.
by Michael Markarian, President of the Humane Society Legislative Fund — Our thanks to Michael Markarian for permission to republish this post, which originally appeared on his blog Animals & Politics on November 21, 2013. Racehorses are impressive, and it would be hard not to be awed by their power and grace. But there’s an important power they lack: unlike other athletes, they have no control over the drugs administered to them. That’s why groups such as The HSUS and HSLF and concerned legislators and citizens must be their voice. Horse race—image courtesy Humane Society Legislative FundThe House Subcommittee on Commerce, Manufacturing and Trade heard that voice today during a hearing on H.R. 2012, the Horseracing Integrity and Safety Act, a bill introduced by Reps. Joe Pitts, R-Pa., Ed Whitfield, R-Ky., Jan Schakowsky, D-Ill., and Anna Eshoo, D-Calif., to protect horses from pervasive race-day doping and other inhumane practices. (A companion bill, S. 973, is sponsored by Sen. Tom Udall, D-N.M.). The legislation would safeguard both the animal and human athletes who participate in the sport, as well as help the racing industry’s reputation recover from bad publicity about cheating and unfair - See more at: http://advocacy.britannica.com/blog/advocacy/2013/11/#sthash.fUr3sx4y.dpuf
Drugmakers had to give up a big chunk of their profits when Obamacare, officially known as the Patient Protection and Affordable Care Act of 2010, was enacted. But the companies didn't seem to mind; well ahead of when the final law was written, the drug industry signed on to the law, giving seniors in Medicare Part D prescription coverage a discount on their drugs. The rebates cover seniors as they hit the so-called doughnut hole after prescription drug coverage runs out but before catastrophic coverage kicks in. In the doughnut hole, senior were responsible for covering the full cost of their prescription drugs, but as part of Obamacare, the pharmaceutical industry agreed to offer seniors discounts. For brand-name drugs, the discount started at 14% in 2012 and will eventually rise to 75% in 2020. Drugmakers with drugs that primarily treat seniors are disproportionally hurt by the legislation, but pretty much all drugmakers will end up losing profits from the discount to seniors. The only exceptions are drugs such as Dendreon's (NASDAQ: DNDN) Provenge and Regeneron Pharmaceuticals' (NASDAQ: REGN) Eyela that are administered by doctors because they're not covered by Medicare Part D.
Obamacare also increased …
Yet the drug industry was largely in favor of implementing Obamacare despite the discounts that cut into drugmakers profits.
Now we know whyAs was widely suspected, it appears the drug industry is going to benefit substantially from Obamacare in the long run.
The IMS Institute for Healthcare Informatics ran some scenarios, including a full implementation of Obamacare and a botched implementation leading to a significant decline in health-care utilization, and found that the difference between the two could be as much as $140 billion in 2017.
Under IMS's rosy scenario, drugmakers stand to profit from U.S. drug spending between $420 billion and $460 billion in 2017. Much of that gain comes from "increased enrollment, screening, removal of caps, and management of existing conditions."
In non-insurance speak, that's more patients, better diagnosis, no maximum payouts, and more spending on chronic diseases, which all leads to an increase in spending on drugs.
If Obamacare isn't instituted, the situation is much bleaker. Drugmakers will only share U.S. spending between $300 billion and $320 billion, which sounds like a lot, but it's actually a decline from the $328 billion Americans spent on drugs in 2012.
In the worst-case scenario, IMS predicts that drug spending will decline because insurers will push back on spending for new medications with premium prices.
Somewhere in the middleIMS's actual prediction is somewhere in the middle. The analysts predict U.S. drug sales will hit $350 million to $380 million in 2017, producing an annual compounded growth rate of 1% to 4% from 2012 levels. The prediction assumes a third of the target levels of enrollment in Obamacare by the uninsured and some pushback from insurers resulting in having drugmakers compete on price.
In that scenario, companies that are developing drugs that treat unmet needs -- Vertex Pharmaceuticals (NASDAQ: VRTX) in cystic fibrosis and Sarepta Therapeutics (NASDAQ: SRPT) in Duchenne muscular dystrophy for example, should be good investment because of a lack of competition and therefore pricing pressure.
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In 2011, a year before the outbreak, the Colorado State Board of Pharmacy detected problems with the NECC when it was determined that the company was distributing compounded drugs in our state that had been manufactured ahead of time without first obtaining patient-specific prescriptions. This left Colorado patients at risk for being given a medication not appropriate for their specific medical needs and necessary health requirements.
Our state board issued a cease-and-desist order to the NECC, and notified the Massachusetts Board as well. But that was all it could do; ultimately, it was not enough to stop the NECC’s actions and prevent the tragic outbreak that swept across the nation a year later. Despite Colorado’s warnings, the state of Massachusetts did not act and, because it was hamstrung by existing regulations, the FDA could not act, either. quoted from here