Author: Peter

There is a new price surge in the pharmaceutical industry—for a limited number of government-issued vouchers that drug makers… are buying to speed products to market…vouchers require the FDA to shorten its decision deadline to six months… Because companies can also sell the vouchers, a lucrative secondary market has emerged. AbbVie agreed in August to pay $350 million for a voucher from United Therapeutics Corp. ,which received it for developing a pediatric cancer treatment…the voucher program is attracting…criticism…These programs allow sponsors to ‘purchase’ a priority review at the expense of other important public health work in FDA’s portfolio… such as reviewing applications for drugs that treat more serious conditions...Adding to the escalating prices: the vouchers have a scarcity value because only seven have been issued…

...House of Representatives’ Committee on Energy and Commerce Subcommittee on Health convened a hearing called "Examining Medicare Part D Medication Therapy Management Program."...aimed at figuring out the best ways to strengthen MTM model as the Centers for Medicare and Medicaid roll out an overhaul… Rite Aid’s director of field clinical services… spoke in favor of expanding MTM…and highlighted recent efforts...which include the introduction of a bill…the Medication Therapy Management Empowerment Act that would increase access to MTM for patients with such chronic conditions as diabetes, cardiovascular disease, high cholesterol and COPD…given community pharmacist’s unique role as an easily accessible healthcare provider, they could be at the center of the expansion of MTM programs.

two steps…the president detailed in a memo all federal departments and agencies…providing prescriber training among federal health care professionals, a move that addresses concerns raised recently by the Center for Disease Control and Prevention, which noted that prescribing behavior was one of the biggest contributors to opioid abuse…need for patients to have access to treatments…Obama has directed federal agencies and departments to…facilitate easy access to health benefits and to find barriers to treatment for those with opioid uses issues.

On second thought, Pacira Pharmaceuticals, the FDA might just take it back...the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices…the FDA warning letter--now taken down from the agency website--Pacira had claimed that Exparel (bupivacaine), its pain drug and lead product, could work for up to three days at a time, though it's only approved for 24-hour pain relief… It would seem like a good old-fashioned pharma-government tussle over what companies can and cannot say about their products. But the argument has changed significantly, thanks to a series of court rulings that could open the door for drugmakers to market their products in previously unacceptable--even previously illegal--ways...

Scientists have found a genetic explanation for why the world's first malaria vaccine is not very effective in protecting some African children against the deadly mosquito-borne disease… The analysis…comes at a critical time for the experimental shot from GlaxoSmithKline, when global experts are assessing how it might be deployed…Mosquirix is specifically designed for use by African babies and toddlers. While it has the potential to help prevent many cases of malaria, researchers have been disappointed by its limited efficacy…scientists have discovered that genetic variability in a protein found on the surface of malaria parasites may help explain the patchy response because, while the protein comes in different forms, GSK's vaccine incorporates only one variant.

A…nurse who admitted taking kickbacks from a drug company that makes…Subsys (fentanyl sublingual) was pressured by sales representatives to increase her prescribing "so that the Subsys numbers would also increase,"…federal prosecutors charged that Heather Alfonso "continued to increase her prescribing of Subsys and to find more patients for whom she could prescribe the drugs" in exchange for a series of $1,000 kickbacks, totaling $83,000, from the company, Insys Therapeutics…the…narcotic is approved only for cancer patients, some of the patients given Subsys by Alfonso "did not have a cancer diagnosis,"...But "prior authorizations" submitted on behalf of patients falsely represented that they had cancer, misleading insurers into paying for the drug…She…was the highest prescriber in Connecticut in 2013, writing $2.7 million in prescriptions.

 23andMe announced the launch of a new consumer genetic test service…that will show whether an individual carries genes associated with 36 different disorders...The new test service…will allow healthy people to see if they carry a genetic variant related to 36 conditions that could be passed on to a child…cystic fibrosis...sickle cell anemia, Tay-Sachs disease and beta thalassemia…The service also provides non-medical details on traits like freckles or hair curliness as well as a person's lactose intolerance….23andMe, which is privately held, is backed by Google Inc and was valued at $1.1 billion in a recent round of venture capital funding.

Interrupted sleep and withholding of food can make hospitalized patients sicker, according to three U.S. physicians who say patient safety in hospitals is not just a matter of preventing falls and infections…adequate sleep and nutrition are key to keeping the immune system strong, but noisy hospital conditions and long wait times may be compromising the body's defenses…poor nutrition, present in up to half of all hospital patients - can contribute to inflammation, muscle breakdown and organ damage…hospitals are busier and as a result we are seeing longer wait-lists for procedures, diagnostic testing, and inpatient transfers such as from the ER..

Yesterday’s POS won’t cut it when it comes to providing a consistent experience across channels… retailers are struggling to unify their online and in-store experiences, with existing technology/infrastructure preventing them from moving forward with new omnichannel solutions… 77% of the surveyed retailers believe their legacy point-of-sale is preventing them from providing a consistent customer experience across channels…retailers…face significant challenges getting new technologies rolled out to stores and in helping employees respond to informed, smartphone-enabled shoppers. Key findings include:

• store and the digital experience must be brought together for a continuous, seamless experience
• getting new technologies rolled out to stores is a top challenge
• inventory insight across all channels is important
• real-time visibility into customer activity across all channels is important

A new report from the Centers for Disease Control and Prevention is shining light on steps that can be taken to prevent opioid abuse and misuse… CDC found that prescribing practices between states vary drastically… demographic differences between states do not entirely explain the variation...the CDC notes that the real way to fix the issue is to improve prescribing practices…A more comprehensive approach is needed to address the prescription opioid overdose epidemic, including guidance to providers on the risks and benefits of these medications…One of the largest contributors to opioid abuse is overprescribing done by a small number of prescribers whose prevalence is different between states…