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K-V Loses FDA Lawsuit Over Makena
K-V's lawsuit alleging that the FDA was allowing "unlawful competition" involving its Makena product was dismissed by a federal judge. The judge threw out the company's claims that the FDA caused it "irreparable harm" by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women. "This case is fundamentally an effort to get the court to direct and oversee the FDA's enforcement activities, and that it cannot do," the judge said in the 38-page ruling.
http://www.bloomberg.com/news/2012-09-06/k-v-pharmaceutical-loses-fda-lawsuit-over-makena-drug.html
KV Cutting Price of Makena
From $1500 per injection to $300�what a drop! KV's price on Hydroxyprogesterone Caproate Injection is again a news item. As a result of the outlandish price compared to the identical compounded version, KV is trying to woo states into placing their product on their state programs and sneaking in statements that only the FDA-approved product should be paid for; even at a higher price than the compounded versions of $20 per injection.
http://www.chicagobusiness.com/article/20120830/NEWS03/120839997/makena-maker-offers-price-cut-for-preterm-birth-drug
Automix IV Feeding System Class I Recall
Baxter is recalling its Automix intravenous feeding systems over concerns that incorrect dosing could lead to patient injury or death; the devices could fail and deliver dangerous and potentially fatal chemical doses to patients.
These systems provide automated IV feeding, pumping nutrients into the body while bypassing the gastrointestinal process. This recall resulted after finding that fluids could leak into the keypad and cause electrical failures that affect the total parenteral nutrition solutions delivered to patients. This could result in patients receiving inappropriate nutrient compounds, or the system may pump nutrition when it's not meant to.
http://www.massdevice.com/news/fda-slaps-baxter-intravenous-feeding-systems-recall-with-class-i-status
Chinese Pharmaceutical Companies Using Gutter Oil in their Production Processes
Chinese authorities have stepped up measures against gutter oil upon finding that more pharmaceutical firms have used gutter oil, a waste material, to replace soy oil in their production processes. The companies stood trial for processing and selling gutter oil (also known as swill oil), oil ladled from drains near restaurants. The State FDA told the country's pharmaceutical firms to carefully scrutinize their sources to prevent such ingredients being used in medicine.
http://english.cri.cn/6909/2012/09/03/2982s720247.htm
Chinese Fake Sales Data on Phony Weight-Loss Product
China Sky One Medical Inc. and its top executives have been sued by the U.S. Securities and Exchange Commission over claims they inflated revenue by about $20 million with fake sales of a weight-loss product, the "Slim Patch." The agency's suit against China Sky is the latest in a series of regulatory actions targeting financial statements from Chinese companies listed on U.S. exchanges; several companies have been delisted.
http://www.businessweek.com/news/2012-09-04/chinese-medical-firm-sued-by-sec-over-phony-weight-loss-product
Report: Health System Wastes $750B Each Year
The Institute of Medicine reports that the U.S. healthcare system squanders $750 billion a year—roughly 30 cents of every medical dollar—through unneeded care, excessive paperwork, fraud, and other waste.
The report states: "If banking worked like health care, ATM transactions would take days. If home building were like health care, carpenters, electricians and plumbers would work from different blueprints and hardly talk to each other. If shopping were like health care, prices would not be posted and could vary widely within the same store, depending on who was paying. If airline travel were like health care, pilots would be free to design their own preflight safety checks—or not perform one at all."
Getting healthcare costs better controlled is one of the keys to reducing the deficit, the biggest domestic challenge facing the next president.
http://www.washingtontimes.com/news/2012/sep/6/report-health-system-wastes-750b-each-year/
California to Use Taxpayer Dollars to Pay for Acupuncture and Massage Therapy?
States are trying to answer one of the health law's most important unknowns: What health benefits should every insurance plan be required to cover? Well, in California, the answer is coming together quickly and, if all goes as planned, acupuncture will be on the list.
Beginning in 2014, the healthcare law will require all insurance plans to cover a specific set of benefits, which includes 10 broad categories that must be included, but left the task of fleshing out a specific list to Health and Human Services; they then turned the job over to the states.
For California, as any other state, it's a bit of a balancing act. The goal is to provide comprehensive coverage while at the same time being mindful of the budget. A package with too many benefits could end up unaffordable and inaccessible to the people that ObamaCare is supposed to cover. This is why you could see discussions over some benefits like acupuncture and massage therapy as states decide what health care counts as essential and what doesn't.
http://www.washingtonpost.com/blogs/ezra-klein/wp/2012/09/01/acupuncture-as-essential-health-care-california-weighs-the-question/
Spain's Government Drug Spending Drops 24%
The Ministry of Health has reported that Spain's government spent 702 million euros on medicines in July 2012, a decline of 24% compared to the 923 million euros-worth of state spending in July 2011. The number of prescriptions dispensed this July fell 14.1% compared to the year before, and government expenditure on prescription items was down 11.4%. Inflation rose 2.2% during the period, and drug prices increased 36% on average, according to local reports.
The large drop in drug spending by the government is due to the series of severe austerity measures which have been rolling out since 2010. The mandatory patient co-payments ranging from 10% for retirees to 60% for working adults have helped, as well as the revision of drug prices on around 4,000 drugs used in the treatment of chronic diseases. Also, on July 1, 426 drugs were officially withdrawn from the government's basic co-payment list, a move which is expected to create savings of 559 million euros by the end of the year.
http://www.pharmatimes.com/Article/12-08-1/Spain_govt_drug_spending_falls_24.aspx
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