- Do links count? FDA to re-examine online drug ads (medcitynews.com)
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...
- Buyers clubs for cheaper drugs help fight hepatitis and HIV (reuters.com)
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...
- This Week in Managed Care: November 4, 2016 (ajmc.com)
Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.
- Brexit threatens supply of new drugs, report warns (reuters.com)
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...
- Zipline raises $25M as it prepares to launch drone delivery medical supply service in U.S. (medcitynews.com)
Zipline, a San Francisco Bay-area company that’s using drones to deliver medical supplies such as blood, (and soon, medication and vaccines) to rural areas and in developing countries, has closed a $25 million Series B round...The funding comes at a time when Zipline is expanding its business in Rwanda and preparing to launch in the U.S...The drone business is planning to launch its drone delivery service in the U.S. next year, as part of a partnership with the White House and the U.S. Federal Aviation Administration...Zipline has been ramping up its medical drone business in Rwanda. The company signed a one-year partnership with Rwanda’s government to deliver blood for transfusions to the western half of the country and plans to start deliveries in the eastern half of Rwanda by the end of the year.
- Under drug-cost attack, Big Pharma CEOs raise the value-based pricing flag (fiercepharma.com)
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...
- Drug flippers exploit pharma’s price-hike climate for fast profit (fiercepharma.com)
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,”...
- Use Canada and the WHO’s ‘essential medicines’ as guides for US drug pricing (statnews.com)
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…
- Walter Reed starts testing Zika vaccine in humans, joining Inovio, NIAID jabs in the clinic (fiercepharma.com)
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.
- Pharmacy Week in Review: November 4, 2016 (pharmacytimes.com)
Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.