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China will grant four global drug companies priority-review status to launch groundbreaking new hepatitis C treatments in China, a rare move to open the lucrative market to foreign players...China's Food and Drug Administration expedites domestic drug applications to encourage innovation. But its lengthy drug-approval process for foreign companies means none of the direct-acting antiviral agents that have been shown to cure more than 90% of hepatitis C patients within a few months have been approved in China, which has among the highest rates of the disease in the world with an estimated 10 million people infected...It shows that the CFDA is serious about prioritizing important new innovative medicines that address real unmet medical need or improve substantially on what's currently available, whether they originate in domestic or [global] pharma companies...The policy also encourages foreign companies to manufacture drugs in China, saying companies will qualify for priority treatment if they submit applications for approvals in China simultaneously with U.S. and European Union approvals and use the same production standards as in those markets.

Walgreens...announced that it has installed 50 safe medication disposal kiosks in Walgreens drug stores across California, representing the first of two programs in California to combat drug abuse...By making safe medication disposal kiosks available in select California stores and expanding to other states this year, Walgreens is taking an important first step to curb the misuse of medications throughout the country...As a pharmacy, we are committed to playing a role in what must be a comprehensive solution to prevent prescription drug and opioid abuse…To kick off the launch of the safe medication disposal program in California, Walgreens will host a series of events with local lawmakers working to fight the drug abuse crisis in the state leading up to the U.S. Drug Enforcement Administration’s National Prescription Drug Take Back Day on Saturday, April 30…Walgreens also is working to make naloxone, a potentially lifesaving opioid antidote, available without requiring a prescription from an individual’s physician at California pharmacies. The medication is currently available with a prescription in California and can be used in the event of an overdose to reverse the effects of heroin or other opioid drugs, and is administered by injection or nasal spray.

Hospital groups and lawmakers hailed a federal agency's decision Wednesday to delay the release of its new star ratings until July...The Centers for Medicare & Medicaid Services, bowing under industry and Congressional pressure, announced...that it would postpone the launch date, scheduled for today...until at least July...The ratings, which will measure hospitals on a five-star scale, are based on 113 measures of inpatient and outpatient quality derived from the Hospital Consumer Assessment of Healthcare providers and Systems survey. Quality measures are grouped in seven categories, giving higher weight to mortality, safety of care, readmissions and patient experience than effectiveness of care, timeliness of care and efficient use of medical imaging...The overall star rating is meant to give consumers an easy metric that they can use to shop for the best care...many industry watchers worried that the data doesn't provide an accurate picture of hospital quality care because it fails to consider patients' socio-demographic status. As a result, some of the nation's most prestigious hospitals that treat lower-income patients may unfairly receive lower star ratings...The delay, he said, was necessary so that hospitals and health systems can work with CMS to improve the rating methodology by taking socio-demographic factors into account...

...the European Parliament...formally approved new rules to help companies protect their trade secrets. The move creates a framework for the European Union in which companies can take legal action against someone who allegedly steals confidential information...The rules...were devised in response to longstanding complaints by corporations that Europe lacks a uniform approach to dealing with the theft of trade secrets...harmonization should allow the creation of a safe and trustworthy environment for European companies, which will see their intangible assets and know-how secured...the rules, known as the Trade Secrets Directive, are sparking sharp protest from numerous organizations that claim the effort may jeopardize the legal rights of whistleblowers and others that attempt to disclose alleged wrongdoing by corporations

The Obama administration...set new standards for Medicaid private insurance plans, which in recent years have become the main source of coverage for low-income people...The rules apply to insurers operating as Medicaid middlemen in 39 states and Washington, DC. Each state runs its own program, although the federal government pays most of the cost. Private insurers now provide coverage to about two-thirds of the more than 70 million Medicaid recipients...the rules specify that insurance companies must guarantee access to certain types of service providers, and that at least 85 percent of what insurers get paid must be spent on medical care. They also envision a quality rating system to help Medicaid recipients pick a plan...The regulation issued Monday is more than 1,400 pages long, and it will take time for states, consumer advocates, and insurers to assess all its implications. The changes start to take effect next Jan. 1, and will take years to fully put into place.

The last few months have witnessed the unraveling of the remarkable life sciences company Theranos, culminating in the latest news that federal regulators may ban founder Elizabeth Holmes from the blood-testing industry for at least two years. The company is also facing a federal criminal investigation into whether it misled investors about its technology and company operations...How has this widely acclaimed biomedical innovator fallen so far, so fast?...Theranos' revolutionary claim...wowed investors, journalists and even groups like the Cleveland Clinic and Walgreens with what you might call an "iMedicine" vision of blood testing...A few drops of blood from a fingertip are collected into a "nanotainer" collection tube and analyzed on the company’s proprietary machine, named after...Thomas Edison. How exactly the Edison devices work is unknown. But the claim was that many – possibly dozens – of tests could be run on those few drops of blood...Millions invested without any proof?...Why didn’t investors and journalists dig more deeply, such as by demanding a head-to-head comparison of Theranos' Edison machine to standard chemistry analyzers?...Part of the problem seems to have been the secrecy surrounding these types of startups...which means that there was...no peer-reviewed information out there about its technology...the leading explanation seems to be that they were enthralled by the company’s charismatic young founder...It still remains possible that Theranos has discovered a breakthrough technology...But even if this increasingly unlikely prospect is a reality, Holmes' erstwhile acolytes need to remember the lessons learned from the pantheon of past pied pipers and summed up by statistician W. Edwards Deming: In God we trust; all others must bring data.

Last month, a coalition of more than 300 medical societies, patient advocacy groups, and others asked Congressional leaders in a letter to help kill a proposal for changing how Medicare pays for drugs administered in clinical settings...They contend that under the less favorable terms of the new plan, many of their members would no longer be able to afford administering drugs in their offices that preserve a patient's eyesight, mobility, or life. As a result, those treatments would shift to a costlier hospital outpatient setting, and thus become unaffordable for many patients...Missing from the list of signatories, however, were societies for family physicians, internists, orthopaedic surgeons, and cardiologists. That might not be surprising: Their members stand to earn more money — for family physicians, more than 40% more — by administering drugs to Medicare patients...Medicare policy promises to make some physicians financial winners and some financial losers...

Latest Pharmacy Industry Healthcare Policy Update Review with Ron Lanton – Government Affairs Strategist for the Pharmacy Podcast Show and President of True North Political Solutions. (podcast 30 min)

Hepatitis C drugs are not the only part of California’s troubling drug spending picture. Despite recent cost-cutting measures, such as putting tighter controls on which patients get coverage for which drugs and when, California’s spending on pharmaceuticals has gone up, and so has the number of pricey drugs it is covering. It’s not clear state agencies have the means to balance drug cost pressures in a way that serves the best interests of patients, taxpayers and public health...California voters are expected to decide in November on a measure to put a ceiling on what the state pays for drugs, and lawmakers have proposed drug price transparency requirements on pharmaceutical manufacturers and health insurers...Medi-Cal (Medicaid) says pharmaceutical costs are kept under control by a strong push toward generic drug use for the 10 million enrollees who get health services through health plans. Up to 95 percent of the prescriptions dispensed by these plans are lower-cost generics...The Department of Health Care Services, which manages Medi-Cal, says it has a 20-year practice of controlling drug costs by negotiating deep discounts with drugmakers...Health consumer advocates and economists argue that paying a lot for some drugs that only treat a limited population may not serve larger public health interests, or be the best use of taxpayer dollars...Are we going to have a sustainable (pharmaceutical) industry where we are making sure the drug companies make enough money where they can bring great new products to the marketplace, yet we control cost well enough that people — all people, even the most vulnerable, have access to the drugs they need?...State Medi-Cal administrators say it’s too soon to assess the sustainability of current prescription drug spending trends. If more high-cost drugs come on the market and treat small populations, it won’t have a major budget impact...

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.