Category:

US ranks first in terms of how its domestic policies contribute to global biopharmaceutical innovation, according to a recent analysis...The report , released by the Information Technology and Innovation Foundation, a nonprofit, nonpartisan research and educational institute focusing on the intersection of technological innovation and public policy, includes findings that assess 56 countries making up nearly 90% of the world’s economy...relative to its share of the global economy (22%), the US contributes twice the share (44%) of global R&D investment in the life sciences...it also pays closer to "the true cost of medicines developed...It means too many other nations aren’t doing their share to bear the costs of biomedical discovery and innovation...This underinvestment in biomedical research is one of the most significant factors slowing the pace of biomedical innovation. Moreover, there’s a game theory problem here where some nations are incented to free-ride off the investments of others...Countries must recognize that excessive price controls are actually damaging to long-term biopharmaceutical innovation...Strong intellectual property rights are vital for a robust life sciences innovation ecosystem; with biologic drugs the frontier of biomedical innovation, countries should implement strong IP protections for biologics, including biologics data exclusivity periods of at least 10 years or longer...

Critics of how prescription painkillers are administered in the U.S. are calling on health officials to phase out hospital procedures and questionnaires used to manage pain...They say the current system inadvertently encourages the overprescribing of addictive drugs like Vicodin and OxyContin, fueling an epidemic of overdoses tied to the opioid medications. Deaths linked to misuse and abuse of prescription opioids increased to nearly 19,000 in 2014, the highest figure on record, according to the Centers for Disease Control and Prevention...More than five dozen nonprofit groups and medical experts sent a letter...to the Joint Commission, a nonprofit agency that accredits U.S. hospitals, asking it to revisit its standards for pain management...The letter specifically takes issue with guidelines instructing doctors to ask patients to assess their pain...Aggressive management of pain should not be equated with quality health care as it can result in unhelpful and unsafe treatment...a bipartisan group of senators introduced legislation that would eliminate the connection between pain survey questions and the payment rates hospitals receive from Medicare.

ASHP created a Women in Pharmacy Leadership Steering Committee to help guide ASHP’s efforts in providing services and support for women pharmacists as they seek leadership positions...Professional opportunities to conduct direct patient care combined with flexible scheduling and six-figure salaries have drawn more...women into the profession...ASHP is preparing for the future of the pharmacy workforce by identifying and addressing barriers to female leadership...To jumpstart the process of building a new generation of female pharmacy leaders, ASHP held several live networking events at both its 2015 Conference for Pharmacy Leaders...and its 2015 Midyear Clinical Meeting & Exhibition...The moderators...shared their own professional experiences and provided insights into ways to grow into leadership. The events served to connect younger women in the early stages of their careers with positive role models...gender shifts and generational changes have a real potential to change the profession...We need to cultivate a new generation of leaders at every level—clinical, administrative, academic pharmacy, and more. And to do that, we need a candid and thorough assessment of the needs that women pharmacists have and the opportunities for advancement…

Rare disease drug specialist Shire has been on a buying streak lately, culminating with its $32 billion deal for Baxalta. Now the company says it is time to build something...The...company intends to invest $400 million to erect a biologics plant in Ireland, its first manufacturing facility in its adopted home country. Shire's only other manufacturing is in the U.S...Construction is expected to begin this summer in Piercetown...it will add 400 jobs when the project is completed in 2019...Shire says it needs the new plant to meet growing demand for its products. It saw good growth last year, underpinned by its ADHD and binge eating treatment Vyvanse (lisdexamfetamine), as well as strong sales from hereditary angioedema products, Cinryze (complement C1 esterase inhibitor) and Firazyr (icatibant). With Baxalta, Shire gets products for treating hemophilia. Some analysts are unsure why Shire is so hot for Baxalta, given the competitive hemophilia market where new drugs could decimate the business going forward...

GAO report also finds inconsistent wait times at individual hospitals...Two years after a nationwide scandal prompted an investigation, unacceptably long wait times persist at Veteran Affairs facilities...An audit by the Government Accountability Office found the VA's method of calculating wait times often conceal the actual time it takes before a patient sees a clinician...The report found that according to the most generous estimate, the official VA wait times underestimate wait times by a factor of two...This report proves what we've long known: wait-time manipulation continues at VA and the department's wait-time rhetoric doesn't match up with the reality of veterans' experiences," said House Veterans Affairs' Committee Chair Jeff Miller, according to the Washington Post. "But given the fact that VA has successfully fired just four people for wait-time manipulation while letting the bulk of those behind its nationwide delays-in-care scandal off with no discipline or weak slaps on the wrist, I am not at all surprised these problems persist."

UnitedHealth, the largest health insurer in the United States, is planning a widespread exit of the Obamacare market due to mounting losses from participating in the program...the Obamacare market has continued to show high risk...Next year we will only remain in a handful of states...UnitedHealth lost $425 million last year due to Obamacare...though United is the most prominent insurer to announce widespread exit from Obamacare, there has been a broader trend of participating insurers struggling to turn a profit...The program has suffered from lower-than-expected enrollment, particularly among younger and healthier customers who are necessary to offset the costs of covering older and sicker enrollees. If insurers start to exit, it will mean less competition, which will drive already rising premiums up even further.

The Australian consumer watchdog says manufacturer Reckitt Benckiser profited substantially and should be fined accordingly...Nurofen’s manufacturer Reckitt Benckiser should be fined $6m for misleading consumers over a range of “targeted” pain products that cost twice as much as its standard painkillers despite all products in the range having the same active ingredient and effect, the Australian Competition and Consumer Commission has found...the federal court found the British company...had engaged in “misleading conduct” by representing that its Nurofen Specific Pain products targeted a type or area of pain despite being identical, and ordered they be removed from supermarket shelves...There needs to be some serious taking away of profit...Targeted painkillers zero in on one vital organ – the wallet...Nurofen did not set out to mislead consumers. Nurofen has cooperated with the ACCC in relation to these proceedings and will fully comply with the court order….

Scientists in Singapore have developed magnetic micro-sized bubbles with cancer drugs on their surface that can be guided to gather around a tumor and then release their payload...Filled with gas, the microbubbles can be coated with particles of both cancer drugs and iron oxide. The iron gives them their magnetic characteristic, allowing a robotic surgeon to guide the bubbles to a tumor’s location and thereby cutting back side effects associated with free chemotherapy in the bloodstream...Once they have reached a tumor, the surgeon would then apply ultrasound to vibrate the microbubbles, shaking loose the drug, which is then close enough to enter the cancer cells more effectively.

Blood-testing start-up Theranos took a number of management missteps that led to its most recent tangle with health regulators...For several months, federal health regulators have raised concerns about the accuracy of the company's blood-testing technology...the Centers for Medicare and Medicaid Services threatened to impose stiff sanctions on the company — including a ban that could prohibit Theranos CEO Elizabeth Holmes from owning or running a lab for at least two years...Theranos has never been forthcoming about its test results...If Theranos is ultimately sanctioned, however, it could spell out the company's demise...

Current political debates...have highlighted specialty pharmacy in a less than favorable manner. When stories in national publications focus on the "Pharma Bro" and question relationships between pharmaceutical manufacturers and specialty pharmacies, we are bound to receive negative attention...The challenges we are currently facing could have dire consequences, and it is because of these challenges that we must participate in advocating for our industry. As a profession, we need to invest our time to gather together, speak up, and interact with our government officials at all levels...As a voice for our industry, we are a voice for our patients. We have the ability and responsibility to speak up, not only for ourselves, but also for the individuals who trust us with their care...Access and affordability of specialty medications are critical. Our patients have unique needs, as well as safety and care issues, and we must be a voice for them on the legislative and regulatory side...The key to winning the hearts and minds of legislators is approaching legislative issues the same way you approach your work every day: patients first. Demonstrate that your primary goal is having a positive impact on your patients’ well-being rather than your own bottom line...For more information on this topic, I encourage you to attend the panel, "The Practice of Specialty Pharmacy and Our Government Representatives" at the upcoming Armada Specialty Pharmacy Summit, on May 3, 2016. Armada, the largest US conference for specialty pharmacy, is an opportunity to learn about relevant industry topics, network with peers, and gain real insight into key issues...