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The Department of Health and Human Services has proposed allowing physicians to prescribe buprenorphine for twice as many opioid-addicted patients as they do now...Buprenorphine is a medication-assisted treatment for opioid use disorder, and certain physicians are permitted to prescribe or dispense the drug in their offices because it has low potential for abuse...Under current usage guidelines, physicians looking to prescribe and dispense buprenorphine must participate in training before receiving a special Drug Enforcement Administration number. Physicians certified to prescribe buprenorphine for opioid use disorder are currently permitted to prescribe it to up to 30 patients in their first year and then request authorization to prescribe it to up to 100 patients—a cap that HHS said "limits the ability of some physicians to prescribe to patients with opioid use disorder."...If the HHS proposal is adopted, then qualified and currently waived physicians will be able to prescribe buprenorphine for up to 200 patients.

Dr. John Alan Littleford, and three others were indicted by a federal grand jury in Denver last week on charges related to the illegal distribution of prescription medication and money laundering...Littleford...Dianna L Smithling...Stanley G. Callas and Scott Alan Eskanos were arrested this morning...defendants are alleged to have dispensed and distributed controlled substances to individuals in quantities and dosages that would enable the individuals to abuse, misuse, and develop or maintain dependencies or addictions to controlled substances. Littleford routinely wrote new prescriptions for opioids when the individuals for whom he was writing the prescriptions should have still had opioids left from a prior prescription...Callas and Eskanos knowingly filled these "early refill" prescriptions written by Littleford. The indictment specifically alleges unlawful distribution of controlled substances to seven individuals who presented as patients at the Pain & Injury Clinic and filled their prescriptions at Crown Point Pharmacy, Sky Ridge Pharmacy...The indictment alleges that Littleford’s unlawful distribution of Oxycodone to two of the individuals resulted in their respective deaths. Finally, the indictment alleges the defendants committed money laundering with the intent to promote the carrying on of their unlawful distribution of controlled substances.

A Medicare proposal to test new ways of paying for chemotherapy and other drugs given in a doctor's office has sparked a furious battle, and cancer doctors are demanding that the Obama administration scrap the experiment...At issue are some of the most expensive drugs for treating life-changing diseases...Medicare now pays doctors and hospital outpatient clinics the average sales price of a drug, plus a 6 percent add-on, somewhat reduced by federal budget cuts. Naturally, 6 percent of a $15,000 drug is more than 6 percent of a $3,000 drug. But does that influence doctors' decisions, raising costs for the government as well as those on Medicare?... The new formula...combines a 2.5 percent add-on with a flat fee for each day the drug is administered...The experiment could become permanent policy if it lowers costs while maintaining quality...Specialist doctors, drugmakers and some patient advocacy groups are trying to compel Medicare to drop the plan. Primary care doctors, consumer groups representing older people, and some economic experts want the experiment to move ahead...Opponents say if that happens, cancer patients will be forced to go to outpatient hospital clinics instead of their local cancer doctor for the latest and most effective drugs. That's because smaller, doctor-owned clinics may no longer be able to afford the upfront costs of cutting-edge medications. In rural areas, patients may have to travel long distances to get to a hospital clinic...

Domestic and foreign drugmakers in Japan may cut spending on R&D as the scope of mandated price cuts for reimbursed products kicks in--suggesting that future investments are at stake...Pfizer and Eli Lilly have raised the issue as a combination of price reviews for pharmaceuticals hits in one of the top 5 reimbursement markets globally...Without stability and predictability in drug prices, investments will go elsewhere...cost cuts raise the risk of less investment in Japan...Reimbursement in Japan was a double-whammy this fiscal year that started April 1 for many drug firms, with price cuts for widely prescribed drugs by Japan's Central Social Insurance Medical Council, known as Chuikyo, reaching as much as 50 percent...Under the formula, drugs with annual Japan sales of more than ¥150 billion ($1.8 billion) and that see sharp sales gains can face cuts...On top of that, the every-other-year price-cut exercise by the government at the same time aims for savings of $1.5 billion. The exact revenue losses for companies won't likely be known until second-quarter results are released--although several companies flagged the issue in fourth-quarter earnings calls... Japan's Ministry of Finance has suggested the price cuts need to be every year as healthcare costs balloon along with a rapidly aging society that requires increasingly expensive care...

At the end of March, over 1,900 people convened in Atlanta, Georgia, at the National Prescription Drug Abuse and Heroin Summit, with attendees including advocates, clinicians, treatment providers, law enforcement officers and government officials…first time heroin was included in the conversation...The conference was put on by Operation UNITE…Of the many discussions held at the summit, the primary takeaways in continuing the fight against opioid addiction include:

1. Reduce Demand
2. Clinician Education
3. Holistic Approach
4. Collaboration

A decade-old drug that was once seen as a commercial flop is getting a second chance to thrive as the fight against the opioid abuse epidemic shifts toward medical treatment in the U.S...Alkermes Plc’s Vivitrol, a $1,300-a-month shot that helps kill the high from painkillers and heroin, is poised to get a sales boost after President Barack Obama’s recent push to give millions of Americans better access to addiction medicines through expanded Medicaid coverage and extra budget funding...Alkermes is getting support from governors, police chiefs and judges who helped start more than 100 programs offering Vivitrol with counseling across 30 states...Nobody steals Vivitrol. Nobody traffics it unless they want to get sober...Vivitrol’s sales revival 10 years after its introduction is unusual in the pharmaceutical industry...The active ingredient in Vivitrol, naltrexone, binds to the same receptors in the brain as opioids and blocks the pleasurable feelings associated with taking narcotics...Designing drugs for addicts comes with thorny challenges: How do you prevent addicts from becoming addicted to the addiction treatment, and how do you prevent them from selling it to other addicts?

The worlds of science, technology and patent law eagerly await the...government’s decision on who deserves patents on what many have referred to as the biotechnology invention of the century: the CRISPR/Cas9 gene-editing technique...Scientists hail CRISPR/Cas9 as more accurate and efficient than other, now-traditional genetic engineering methods...CRISPR has generated worldwide debate about how it could accelerate the manipulation of plants, animals and even human beings at the molecular level. That some DNA modifications can be passed on to future generations raises particular concern...But the patent dispute, focusing on whether scientists at the Broad Institute of MIT and Harvard or those at University of California, Berkeley invented the technology, seems far from these ethical concerns...the...Patent and Trademark Office, which will make a decision in the next few months...But amid all the breathless anticipation, we’ve been ignoring two important lessons from the CRISPR/Cas9 patent dispute: patent systems no longer fit the realities of how science works, and patents give their owners significant control over the fate and shape of technologies.

• Do we need patents to stimulate innovation?
• Power of patents, in absence of regulations
• CRISPR’s future use in one institution’s hands

In the latest effort to push back against drug costs, the California legislature will hold a hearing on Wednesday to review a bill that would require companies to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would have to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move...The legislation, which would also require insurers to provide regulators with spending data on prescription medicines...The...bill "will bring prescription drugs in line with the rest of the health care sector by shedding light, for the first time, on those drugs that are having the greatest impact on our health care dollar," said state Senator Ed Hernandez...The Pharmaceutical Research and Manufacturers of America...in its own letter opposing the bill, argued that the reporting requirements are "extraordinarily broad" and would potentially apply to many drugs for which the impact of a price hike on insurance premiums would be "essentially" minimal and "would reflect an imperceptible change in the total cost of care."...BioCom maintained that the bill fails to require payers and pharmacy benefits to similarly disclose their reasons for increasing copayments, deductibles, and out-of-pocket expenses for consumers...

...Medicare is in trouble...The program -- designed to protect our nation's senior citizens by covering some of the eligible costs tied to their hospitalization and outpatient care -- is on an unsustainable course...the Hospital Insurance Trust Fund stands just an estimated 14 years away from burning through its excess cash reserves...2030 would be the year Medicare's HI Trust exhausts its cash reserves...Once the cash reserves...are exhausted, hospitals would only be reimbursed at a rate commensurate to what the program brings in via payroll tax revenue...Medicare's prescription drug problem...prescription drug costs that Medicare Part B covers...include injections given on an outpatient basis by a physician...the real culprits the GAO report identified for rising Medicare Part B expenses are new Part B prescription drugs...between 2007 and 2013, new prescription drug introductions...83 in total, added $5.4 billion in costs to Part B...almost two-thirds of Part B new drug treatments are for ophthalmologic or cancer-based diseases...these are not inexpensive indications...Nine drugs wreaking havoc on Medicare's bottom line (total expenditures in 2013)...

• Lucentis: $1.37 billion
• Eylea: $1.09 billion
• Prolia: $665 million
• Treanda: $332 million
• Lexiscan: $257 million
• Yervoy: $224 million
• Privigen: $184 million
• Provenge: $183 million
• Soliris: $150 million

Fifty four large investors managing 1 trillion pounds ($1.41 trillion) in assets have launched a campaign to curb the use of antibiotics in the meat and poultry used by ten large U.S. and British restaurant groups...McDonalds and JD Wetherspoon were among those to receive a...letter from institutions including Aviva Investors asking them to set a timeline to stop the use of medically important antibiotics in their supply chains...The other eight approached were Domino's Pizza Group, Brinker International, Darden Restaurants, Mitchells & Butlers, Restaurant Brands International, Restaurant Group, The Wendy's Company and Yum! Brands...The move follows warnings from the World Health Organization that the world is moving towards a post-antibiotic era in which many infections would no longer be treatable because of the overuse of antibiotics...Drug-resistant infections could cost the world about $100 trillion in lost output by 2050...