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Seeking to address rising concerns about prescription medicines, the watchdog arm of the Department of Health Human Services is adding to its list of pharmaceutical issues to be examined...The...Office of Inspector General...is trying to widen its focus as questions accelerate about drug costs and the sources for some medicines, according to a new work plan released today...the new issues that are being studied: the amount of medicine that may be wasted when cancer treatments...are distributed in single vials; the amount of money the government might save in the Medicare Part B program if rebates were tied to inflation; and questionable billing for topical medicines that are compounded and covered by Medicare Part D...The OIG is devoting more resources and “drilling down” as concerns rise over drug pricing and accompanying billing patterns...Prescription drug oversight is a top priority…

It’s back to the drawing board for the FDA...After years of slow reaction to pharma marketing online, the agency announced this week a new research initiative to better understand how consumers process short-form posts and ads...the FDA is trying to determine whether links in tweets and Google ads can independently convey all the necessary information about product risk...Under current guidelines, drug companies are required to balance the information they provide in character-space-limited posts. That means for a typical 140-character tweet, at least 70 characters must be dedicated to explaining risks and side effects...Regulatory change could be good news for pharma marketers, who have for a long time sought clarity on what they can and cannot do...

Smart pharma CEOs are getting ahead of the drug pricing argument. Rather than getting in the trenches to defend their price tags, they’re flanking the fight by talking up value-based payer deals...Novartis chief Joe Jimenez and Amgen CEO Robert Bradway...have spoken out publicly about pegging drug costs to their results. They’re veterans of the practice--Novartis has performance-based contracts on its heart failure med Entresto, for one, as does Amgen on its PCSK9 cholesterol-fighter Repatha--so they can already claim to be part of the spending solution…the entire pharma industry needs to move to value-based models that focus on outcomes, not per-unit pricing...Jimenez actually paints pharma as a potential standard-bearer for healthcare spending in general...We believe in the efficacy of our products, and by collaborating with payers on solutions for reimbursement, we hope to help start a shift toward value pricing in the healthcare system...We want to be rewarded for the tangible outcomes our products provide patients, not for simply selling pills...

Drugmakers currently use the European Medicines Agency as a one-stop-shop to get drugs licensed across Europe, but Britain is likely to drop out of that system if it severs EU ties and leaves the single market in a scenario dubbed "hard Brexit"...An approach to leaving the EU which saw ideological considerations placed above securing the right relationship for the economy and for UK patients would see the UK life sciences sector relegated to a second-tier player...Being cut off from the European system could put British patients at the back of the queue for new medicines because applications for new licenses from Europe...warning comes amid growing concern that Britain's successful pharmaceutical and biotechnology sector could be hit hard...In addition to worries about trade barriers and drug regulation once Britain leaves the EU, industry executives are concerned about their ability to recruit foreign staff and loss of EU science funding...

The proliferation of counterfeit medicines is nothing new to pharma; however, the scale of the problem seems to be escalating, especially with the Internet providing an easy means for fraudsters to dispense their fakes. Counterfeiting has a devastating impact on public health and the economy. Not only are consumers paying for products of inferior quality, but their wellbeing is also put at risk. For genuine drugmakers, profits are diluted, but the repercussions extend beyond that…The European Union Intellectual Property Office reported...that the pharmaceutical industry is stripped of approximately €10 billion ($ xxxxx) of revenue every year because of counterfeit medicines...the lost sales translate into 37,700 jobs lost across the pharmaceutical sector in the EU as a result of legitimate manufacturers and distributors employing fewer people than they would do had this problem not existed…With serialization and track-and trace legislations being rolled out over the next few years, pharma is doing its part to secure its supply chain. The problem will be an ongoing challenge for the industry, but with advances in technology, it will become easier to detect the fakes in the near future...

Finding ways to price pharmaceuticals fairly will be a top priority for the next president and Congress. In tackling this thorny issue, they should use the World Health Organization’s essential medicines list as a starting point for the discussion and the Canadian system for negotiating drug pricing as a guide...The WHO launched the concept of essential medicines...in an attempt to provide developing nations...with a minimum list of medications required for a functioning health system. According to the WHO, essential medicines satisfy the priority health care needs of the population...the Canadian drug pricing system…is determined through a multi-tiered process tied to the approval of the drug. It is first evaluated for safety, quality, and efficacy by Health Canada...Once approved...the Common Drug Review looks at cost-effectiveness based on the price set by the pharmaceutical company and the prices for existing treatment options. In parallel, the Patented Medicine Prices Review Board...compares pricing data from other countries…the pan-Canadian Pharmaceutical Alliance...begins negotiations with the pharmaceutical company around price. Once a single price for a drug is determined, an agreement is made to list the drug on provincial and territorial formularies...The set price...is often kept confidential...This isn’t a completely foreign idea for the US health system. It has been used before in emergencies...There is an opportunity to test a new framework for drug pricing in the US. A multi-level system, where approval is tied in with pricing…As well, the creation of a dedicated pharmaceutical negotiations group...It could serve a stopgap function to set pricing limits based on comparative cost-effectiveness data with existing alternatives and prices…

In a move that illustrates the stepped-up pace of Zika vaccine development, the Walter Reed Army Institute of Research is moving into human testing for its candidate, which uses an inactivated virus to spur immunity to the disease...It's the third Zika-fighting shot to step into the clinic...after Inovio Pharmaceuticals...and the NIH…Walter Reed plans to enroll 75 adults in a Phase I trial of that Zika purified inactivated virus (ZPIV) vaccine...To bolster its Zika effort, the institute has brought in other experts: It partnered with flavivirus vets at Sanofi Pasteur and Brazil’s Fiocruz. The collaborative effort has additional governmental assistance from the National Institute of Allergy and Infectious Diseases, and the Biomedical Advanced Research and Development Authority is contributing funding.

Amid the election fervor...Walgreens Boots Alliance quietly took action against its former partner, Theranos, for breach of contract...The retail pharmacy filed a $140 million lawsuit against the embattled blood test device maker, suing for breach of contract…”We are disappointed that Walgreens filed this lawsuit," Elizabeth Holmes...founder and CEO of Theranos said in a statement. "Over the years, Walgreens consistently failed to meet its commitments to Theranos."...On June 12 Walgreens announced that it would terminate its relationship with Theranos and close all 40 of its Theranos Wellness Centers, which operated in Arizona. This followed the company's January announcement that it was halting Theranos lab testing operations at its Palo Alto, Calif. location.

Frustrated by the high price of antiviral drugs, thousands of patients from London to Moscow to Sydney are turning to a new wave of online "buyers clubs" to get cheap generic medicines to cure hepatitis C and protect against HIV infection...While regulators warn that buying drugs online is risky, scientific data presented at a recent medical conference suggest that treatment arranged through buyers club can be just as effective as through conventional channels...The buyers clubs' websites act as middlemen by providing details of trusted online pharmacies and drug manufacturers, exploiting a loophole in World Trade Organization patent rules that allows small-scale imports of medicines for personal use...the advent of today's buyers clubs is just the latest chapter in an ongoing war over drug prices...

Hefty drug price increases have been an outrage-provoking subject for politicians, the public and pharmacy benefits managers all year long. But another group besides drugmakers has been benefiting from them: dealmakers...Private companies have been taking advantage of climbing prices by buying older drugs on the cheap, hiking their stickers, and reselling them…drug flippers aren’t the only price-hike offenders. Plenty of drugmakers have notched sizable increases on meds that haven’t changed hands at all, and one need only look at key Mylan blockbuster EpiPen...they’re taking advantage of a dysfunctional market...A lot of jacked-up drugs still do fly under the radar...while drug flippers may not be the only group contributing to skyrocketing drug costs, “the bottom line is it all adds up,”...