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 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.

A new coalition of 20 healthcare organizations has come together to form the Patients Alliance for Drug Safety Protections, whose goal is to tout the public health benefits of Risk Evaluation and Management Strategies. The PADSP has also launched a website, DrugProtections.org, that explains the REMS program to patients and lists medication(s) that are currently marketed with a REMS…We encourage healthcare organizations to work collaboratively to design and conduct drug studies in order to ensure that people with serious diseases have access to appropriate treatments…

In a previous post—now almost one and a half years ago—I described "the coming storm" I anticipated would develop around the 340B drug discount program. After a brief tornado hit the House Energy and Commerce Committee when they considered including 340B reforms in their 21st Century Cures initiative, a slower, hurricane-style churn over the Administration’s proposed guidance on the topic has settled in…With the October 27 comment window steadily approaching, let’s take a look at what the rule says and what it could mean for interested stakeholders.

• A Brief History Of 340B
• What Happened At The Energy And Commerce Committee?
• What’s In The HRSA Guidance?

AstraZeneca Plc opened a new $224-million factory in Russia…The move is intended to reinforce the group’s long-term commitment to the country which is one of the drugmaker’s key emerging markets…it…opened a new manufacturing and packaging plant in the Kaluga region southwest of Moscow…largest foreign investment in the construction of a new pharmaceutical facility in the country…the plant to reach full capacity in 2017 and to produce about 40 million packs and 850 million tablets of some 30 medicines every year, which represents more than 60 percent of the medicines the company sells in Russia...

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…

Sharing electronic health records access between physicians and pharmacists can improve workflow efficiencies for both… that pharmacist involvement in patient’s medication therapy improves adherence and reduces costs. However, since it is not financially feasible for many physicians to employ full-time pharmacists, collaboration is often the best alternative…Sharing EHR access is one way that collaboration can benefit patients while simultaneously improving workflow efficiencies…Pharmacists were able to more readily collect data related to patients’ medical conditions, prescribed medications, lab data, and treatment plans. Communication between the pharmacists and providers was significantly enhanced...

During an inspection of Qualgen’s facility in Edmond, Oklahoma, FDA investigators observed "insanitary conditions, including poor sterile production practices, which raise concerns about Qualgen’s ability to assure the sterility of drug products that it produced," said the agency…The FDA recommended the company cease sterile operations until it fixed the problems, but Qualgen agreed only to voluntarily recall 67 lots of drugs. The recalled products were compounded before September 1, 2015 and have not yet expired…The Food and Drug Administration said it is not aware of any adverse events associated with Qualgen’s products…

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...

...the IMS Institute has just snuck out an interesting report: Emergence and Impact of Pharmacy Deductibles: Implications for Patients in Commercial Health Plans. The report’s overarching theme is unsurprising: Higher out-of-pocket costs reduce patients’ adherence to drug therapy and increase prescription abandonment rates…The report’s major contribution, however, links the growth in pharmacy deductibles to manufacturers’ copayment offset programs, which cover a beneficiary’s out-of-pocket costs for a brand-name drug. High deductible plans are shifting costs from payers to consumers and—in many cases—back to manufacturers.

Examples of big brands altering their commercial approach away from the rep-driven model have often involved mature products. Those in the sunset of their patent life provided drugmakers a haven for experimenting with alternative marketing channels: non-personal promotion, sophisticated CRM (customer relationship management)… we're in the middle of significant structural change…Digital transformation can be a key enabler of success in some really challenging and very fiercely competitive markets. But it's going to [require] us to do things very differently...