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...Anthem Inc said it had sued pharmacy benefit manager Express Scripts Holding Co to recover damages from drug pricing it believes was too high...latest development in a months-long dispute over Anthem's contract with Express Scripts...The lawsuit also seeks to recover damages from operational issues and for a declaration of Anthem's right to terminate its contract with Express Scripts…Anthem, which has been seeking $3 billion in annual cost savings through a repricing provision in its 10-year contract with Express Scripts, said it had not yet decided whether to end the contract...The latest news has taken a very unhealthy turn and we see it unlikely that Anthem renews its contract with Express Scripts past 2019, and is likely to leave sooner to the extent it can manage the transition for consumers smoothly...Express Scripts...said in a statement that it believed the lawsuit to be without merit. The company has consistently acted in good faith and in accordance with the terms of its agreement with Anthem…

The National Association of Chain Drug Stores...announced the expansion of its get-out-the-vote initiative for 2016, with new video ads to encourage pharmacy personnel to volunteer and vote for the candidates of their choice...The new ads are part of the larger NACDS RxIMPACT Votes get-out-the-vote effort, one aspect of NACDS’ suite of grassroots advocacy resources under the NACDS RxIMPACT name. The ads will bear the "hashtag" #PharmacyVoter that will be used in social media to foster a community-wide focus on voter engagement. NACDS also launched PharmacyVoter.org – a website targeted to the pharmacy community to showcase the effort... The first 30-second ad — called "Effective" — debuted...during the launch of NACDS RxIMPACT Day on Capitol Hill, when nearly 400 pharmacy advocates will meet with 90% of the U.S. Congress to discuss key patient care issues.

America's love affair with prescription drugs began in the 90s when narcotic pain killers left the hospital and headed home in the form of a pill..."Pain killers began being prescribed at such a high rate, and the folks who were prescribing them didn't necessarily have any training," said Jennifer Delette-Snyder...of Join Together Northern Nevada..."Think of Heroin. An opioid in a pill is the synthetic form of that type of a drug,"..."A surge in painkiller prescribing has been the main driving force over this epidemic and of the heroin epidemic," said Dr. Tom Frieden, Director of the CDC...This week the agency started to combat the problem by issuing new guidelines (for) the prescriptions of opioids. The guidelines say opioids should not be the default solution for pain care..."People don't realize that these opioids are lethal. No one ever takes a pill thinking that it is going to kill them and this is the type of awareness that we are trying to build," said Teresa Benitez-Thompson, Nevada Assemblywoman from District 27...Doctors in Nevada now have to log opioid prescriptions in a database. The practice prevents patients from doctor shopping as well as prevents doctors from accidentally over prescribing...Delette-Snyder says both the CDC actions and the legislature actions have the potential to save lives, but she says we need to stay the course and only look to opioids for only the most extreme situations...Physicians could go back to prescribing only Ibuprofen, but only time will tell if they will. The CDC guidelines are only guidelines. They are not a mandate.

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

According to PDS (PDS Life Sciences), SEND Express is a "turnkey solution for the generation of Standard for Exchange of Nonclinical Data datasets."...We aggregate and harmonize data from multiple organizations, information systems and file formats...to produce one set of harmonized SEND files, including define.xml and define.pdf, as required by the FDA...The platform's launch parallels the FDA's deadline for standardized electronic data submissions, which will require all datasets from studies supporting new drug applications, biologics license applications, and abbreviated new drug applications to be submitted in SEND format by Dec. 17...Having an industrywide, harmonized model allows for efficient analysis by regulatory authorities...The common formats assist in enabling the exchange of nonclinical data within companies and consortiums...this consistency of data makes it easier for vendors to develop tools that can use this data...

World Health Organization has suspended the approval of tuberculosis drugs made by India's Svizera Labs, a major supplier to developing countries, following an investigation into standards...The United Nations agency, which acts as a drug watchdog in markets lacking robust local regulation, said on Friday it had suspended all TB products made at Svizera's Mumbai site because manufacturing standards and quality management were unreliable...It also said independent experts should retest batches of medicine already on the market and it might be necessary to recall supplies, depending on the outcome of those tests...The move is a fresh blow for India's pharmaceuticals industry, which supplies cheap generic medicines to countries worldwide but has been tarnished by a series of quality problems in recent years, denting confidence in its products...The WHO plays a critical role in monitoring drug quality in poorer countries through its Prequalification of Medicines Program, which ensures that treatments supplied by U.N. agencies such as UNICEF are of acceptable quality.

When US lawmakers convened a hearing last month to discuss the pricing of prescription drugs, it was the testimony of Martin Shkreli...that garnered the headlines. But the hearing also looked at an issue that...could make drugs more expensive for far more people…The impetus was October’s announcement from Walgreens...that it was buying Rite Aid...Critics said that would create a drugstore duopoly with CVS, the market leader. They didn’t, however, look as hard at another effect of the deal, which likely will bring about the final collapse of the industry tasked with keeping prescription-drug costs under control...Buried inside Rite Aid is a bundle of pharmacy benefit managers...Walgreens says that acquiring Rite Aid’s PBMs would help it compete with arch-rival CVS, which controls a large and extremely profitable PBM called Caremark...combining pharmacies and PBMs under one roof creates a conflict of interest. It can restrict patients’ access to certain prescription drugs, and can prevent independent drugstores from competing fairly for new customers...As "competition decreases,"..."prices are going to increase. That’s what we’re finding now." If Walgreens successfully acquires Rite Aid and its PBMs, one of the industry’s last remaining constraints on drug prices will disappear.

A British vote to leave the European Union would threaten some prescription medicines with regulatory limbo, posing a legal headache for drugmakers, according to lawyers and industry officials...The highly regulated pharmaceutical sector has more at stake than most from a so-called Brexit, prompting top manufacturers GlaxoSmithKline and AstraZeneca, both of which oppose exit, to draw up detailed contingency plans...Currently, under EU rules, drugmakers launching a medicine get a single marketing approval that allows them to tap the entire European market of 500 million potential patients...In the event of a British exit, UK firms could no longer apply for or hold EU marketing authorizations, unless or until the UK negotiated to be part of the EEA. Licences would have to be transferred to businesses inside remaining member states..."The potential complexities around such issues as marketing authorization simply highlight the problems that could be faced by companies and patients alike in the event of exiting the EU,"...GlaxoSmithKline said leaving the EU would create uncertainty, add complexity and making some short-term disruption likely...

Patients with pancreatic cancer living in Wales will no doubt welcome news that Celgene’s Abraxane will continue to be available on the National Health Service in the country, despite a decision by the National Institute for Health and Care Excellence to reject its use...NICE confirmed back in November that Celgene’s Abraxane (nab-paclitaxel) will not be routinely funded for use in combination with gemcitabine for treating pancreatic cancer on the NHS in England and Wales, claiming that the drug’s cost does not justify its benefit to patients...the Institute said while the Abraxane/gemcitabine combination was more effective than the latter drug alone, it resulted in more serious side effects, and also caused more adverse events than a gemcitabine/capecitabine regimen despite having similar effectiveness...in a rare move, the Welsh government (All Wales Medicines Strategy Group) has now stepped in to ensure continued access for metastatic pancreatic cancer patients in Wales, on the back of data from the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, which showed an increase in median overall survival of 1.8 months with Abraxane in combination with gemcitabine, when compared to gemcitabine alone.

...Centers for Medicare & Medicaid Services spends $20 billion a year for drugs under Part B, which are those given in doctors’ offices and hospital outpatient centers. Many cancer treatments are provided that way, as are some treatments for rheumatoid arthritis, macular degeneration...Under a proposed rule, different methods would be tried in selected geographic areas over a five-year test period. Some of these experiments would begin this year, with others added in 2017...Dubbed "value-based pricing," such largely unproven ideas are the latest tactics being tried to slow growth in prescription drug spending amid rising public alarm about drug prices...The goal is to test whether alternative approaches will lead to better value...There is no perfect payment system, they all have upsides and downsides...What we don’t want to do is create a world where doctors only prescribe the cheapest stuff even if not in the interest of the patient...Here are four concepts the government is investigating:

1. Cut drug reimbursements for doctors and outpatient hospital centers.
2. Level payments.
3. Tie payments to effectiveness.
4. Cut patients’ out-of-pocket costs.