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A US senator is urging the US Federal Trade Commission to accelerate its antitrust investigation into a drug maker that sells Suboxone (buprenorphine/naloxone), a medicine used to treat addiction to opioids and narcotics...The appeal by Senator Edward Markey comes less than a week after 35 states filed an antitrust lawsuit against Indivior (Reckitt Benckiser), accusing the company of engaging in a scheme to block generic competition. In doing so, the company "drove up prices and deprived states and consumers of lower costs," Markey wrote in his letter on Tuesday to FTC…Reckitt raised the price of its pill while lowering the price of the newer film version. And the patent on the new version does not expire until 2023. This is a pharmaceutical industry tactic known as forced switching, since patients and physicians have little choice but to consider a newer, higher-priced version...Markey also pointed out that the manufacturer has "significantly impeded the FTC investigation by attempting to deny the FTC access to thousands of pages of documents that are integral to the investigation." However, he also noted that the federal court overseeing the matter later ordered the company to produce the documents...So will the FTC step on the gas?

A North Las Vegas doctor was arrested...in connection with a lewdness incident involving a patient...detectives arrested Jorge Burgos, 50, at his office in the 1800 block of East Lake Mead Boulevard on multiple counts of open and gross lewdness...Allegations were made that on multiple occasions, the doctor inappropriately touched a patient...Police said the investigation is ongoing, and they are seeking other possible victims...Burgos, an internal medicine physician, has no record of disciplinary actions by the Nevada State Board of Medical Examiners.

U.S. lawmakers...blasted Mylan NV Chief Executive Heather Bresch for sharply increasing prices for the EpiPen emergency allergy treatment at a congressional hearing in which Republicans and Democrats questioned the reasons behind rising U.S. drug costs...The House Committee on Oversight and Government Reform called Bresch to testify in the wake of public outrage over EpiPen, whose list price has risen to $600 for a pair of the devices compared with $100 in 2007...Lawmakers in turn described the actions as "sickening," "disgusting" and showing "blatant disrespect" for American families who can no longer afford the life-saving device for children susceptible to severe allergic reactions...At several points, they cut off Bresch's efforts to explain the intricacies of U.S. pharmaceutical pricing, including how health insurers and other payers take a percentage of treatment sales...

Prescription drug prices increased 6.3% over the last year, according to consumer price index data...You’ve been paying more for prescription drugs — and it’s not just Mylan’s EpiPen...Prices for prescription drugs increased 6.3% over the last 12 months, the highest year-long prescription drug price increase in over a year and a half, government consumer price index data shows...Data from the CPI, which examines changes in what consumers are paying for day-to-day goods and services, lends support to the idea that broad changes in health care are having repercussions for consumers alongside health insurers and other players...Drug prices are indeed rising, and have been for many years. But the phenomenon is exacerbated by another health care trend, the rise of high deductible health insurance plans, which shift more of health care costs to consumers...Though other factors, such as new terms of health insurance plans, could also be at play, “I think the hidden secret here is it’s the consumer’s out-of-pocket costs that are increasing,”...Search data...shows that consumers have reacted to the trend by shopping around...

Diabetes may be a widespread disease for which millions of people need treatment, but a new analysis finds that developing new medicines has been a risky proposition for drug developers...How so? Here are a few key findings:

• Only 1 in 13 investigational diabetes drugs that entered clinical testing from 1995 to 2007 ultimately received regulatory approval, compared with 1 in 8 for all investigational drugs…
• The likelihood that a diabetes drug entering clinical testing would make it to late-stage testing was about 13 percent...
• the most important challenge for drug makers...continues to be the regulatory approval process, which has grown more demanding in the wake of a controversy in 2008 over the heart risks of a widely used diabetes drug.
• so-called first-in-class approvals for diabetes — which refers to new types of medicines — represented almost 30 percent of all FDA approvals.
• of all new diabetes drugs that were approved by the FDA from 1995 to 2015, 15 percent received a so-called priority review designation...
• The 61 diabetes and other endocrine drugs approved from 1995 to 2015 accounted for 10 percent of all new medicines approved by the FDA during that time...

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

...2bPrecise (subsidiary of Allscripts) is conducting an early adopter program at the National Institutes of Health...The goal is to take clinical and genomic information and make it actionable, structured, machine-readable and machine-learning for physicians. And then take those results and inject the relevant information back into workflows...We focus on the last mile of genomics and cross-collating clinical info with genomics and bring it to the point-of-care...With NIH, we’re putting this to the test and demonstrating the value of genomics in clinical and research activity…People are recognizing genomics is needed, powerful and useful...What’s missing are regulations and reimbursement around this type of data. As healthcare continues to move into this space, I think we’ll see another spike in interest, with a huge level of interest and motivation to try to use genomics more…

The Department of Health and Human Services issued its final rule on submitting registration and summary results to clinicaltrials.gov. In a nutshell, the new guidelines define which clinical trials must be registered and when, how results should be reported (and when) and potential penalties for non-compliance...The rule seeks to clarify the Food and Drug Administration Amendments Act of 2007, which left significant room for interpretation...Enhancing access to clinical trial information means more useful data for patients and scientists. People who have exhausted their treatment options may have more access to experimental therapies. Scientists can build on trial success and avoid failures...Overall, the rule is getting good reviews for its effort to increase transparency and respond to systemic flaws...It reflects that we have this learning healthcare system, which is what we want...We want laws that learn, that take feedback and are able to understand what is working and what is not working and be amended in order to work better...

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.

Healthcare organizations and manufacturers are very vulnerable when it comes to their data protection measures, according to the Intel Security 2016 Data Protection Benchmark Study...While the gap between data loss and breach discovery is increasing, healthcare organizations are “sitting ducks,”...the typical data loss prevention approach is increasingly ineffective against new theft targets...Not only is data getting outside of company control, it has probably been used or sold before the theft is noticed...Discovering and preventing breaches internally requires a better understanding of who is behind these thefts, what they are most likely to steal, how they are getting the data out, and the most effective steps to take to improve data loss prevention systems and processes...Healthcare is likely a top target because it holds desireable information - PHI and intellectual property. At the same time, healthcare typically has weaker systems that can be easier for hackers to access...