Author: Peter

U.S. women will soon have another drug option designed to boost low sex drive: a shot they can give themselves in the thigh or abdomen that raises sexual interest for several hours...The medication OK’d...by the Food and Drug Administration is only the second approved to increase sexual desire in a women, a market drugmakers have been trying to cultivate since the blockbuster success of Viagra for men...The upside of the new drug “is that you only use it when you need it,”...“The downside is that it’s a shot — and some people are very squeamish.”...The FDA approved the new drug, Vyleesi (pronounced vie-LEE’-see), for premenopausal women with a disorder defined by a persistent lack of interest in sex, causing stress. The most common side effect in company studies was nausea...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The National Association of Chain Drug Stores today praised Texas’ enactment of a bill (HB 2174) to address opioid abuse and addiction, while providing key safeguards to address the needs of those suffering from chronic pain...the new law will require electronic prescribing for controlled substances, to help prevent fraud and abuse. It also will limit the supply of a patient’s first opioid prescription to 10 days, when that prescription is for temporary, or acute, pain. It is important to note that this limit does not apply to prescriptions for ongoing, or chronic, pain. It also does not apply to cancer care, treatment of other illnesses, or end-of-life care...READ MORE

A Department of Veterans Affairs program launched last week will offer military veterans new options in accessing health care...The Maintaining Internal Systems and Strengthening Integrated Outside Networks Act, or Mission Act, essentially expands on earlier legislation intended to cut down on wait times at VA medical facilities by allowing veterans to see private doctors in some circumstances...“It was a temporary fix at that time to deal with wait times and scheduling issues,” Chuck Ramey, spokesman for the the VA Southern Nevada Healthcare System in North Las Vegas...“The VA has been working with the community to provide community care since day one.”...Under the new program...veterans can work with their VA health care provider or other agency staffers to see if they are eligible to receive care from local non-VA doctors...Dr. Ramu Komanduri, chief of staff at the VA facility in North Las Vegas, said the new act “offers many more opportunities for the veteran to make a choice.”...READ MORE

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

A report from the EUIPO demonstrated that a shift in the focus of counterfeited goods to include pharmaceutical products has caused significant loss of sales and employment...The European Union Intellectual Property Office has released a report this month regarding 11 analysed sectors in the region, including the pharmaceutical industry...The European Union organisation found that all analysed sectors lost sales as a result infringement of intellectual property rights for a total of €92 bn ($106bn) between 2013 and 2916...the pharma industry suffered the second biggest loss of sales, at €16bn…READ MORE

...Sanofi has teamed up with Google to work on innovations, aimed at using emerging data technologies to change how medicines and health services will be delivered in future...Sanofi and Google will use data sets to improve their understanding of key diseases and extract patients’ insights and feedback...Combining Sanofi’s biologic innovations and scientific data with Google’s industry-leading capabilities, from cloud computing to state-of-the-art artificial intelligence...READ MORE

The FDA has tied the contamination of blood pressure drugs by probable carcinogens to an approved switch in manufacturing to a process that uses certain solvents. Now an online pharmacy says it has discovered the solvents are as bad as the impurities they have been creating and has criticized the FDA for not taking steps to limit their use...In a citizen petition...Valisure says the FDA has established acceptable limits for impurities such as those commonly known as NDMA and NDEA after they were discovered in heart drugs last year, leading to massive global recalls...But it claims the FDA has not lowered the acceptable level for the solvent DMF, although it “has become apparent that the switch in the manufacturing industry to the use of the DMF solvent may be largely responsible” for the appearance of the impurities in the U.S. drug supply...The petition says the FDA needs to investigate the use of the solvent N,N-Dimethylformamide in drug manufacturing since it is classified as a Class 2 carcinogen...READ MORE

Scott Gottlieb (Former FDA Commissioner) warns that health benefit claims about CBD have gotten well ahead of what science actually knows about the substance...“The idea that you can put it in dog food and it’s going to calm your dog ... I think that’s pretty hokey,” he says...CBD is not a “benign compound,” and regulations will be needed to protect people from possible unknown side effects, Gottlieb said...READ MORE

Nevada Attorney General Aaron Ford filed a lawsuit...in Clark County District Court accusing dozens of drug manufacturers and distributors of propagating the state’s deadly opioid epidemic...The 241-page complaint names more than 40 defendants, including prescription drug makers such as Purdue Pharma and Teva Pharmaceuticals, and distributors including CVS, Walgreens and retail giant Walmart...It accuses drug manufacturers of pushing doctors to prescribe the addictive medication while downplaying the side effects. It also alleges that distributors supplied many more opioids than justified for the Nevada market, ignoring data that allowed them to track overprescribing...READ MORE