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President Obama has signed a law that resets approval dates for some medicines that contain controlled substances. The goal is to streamline the process used by the Drug Enforcement Agency to place prescription drugs that are controlled substances on a list of medicines for which distribution is restricted…the new law ensures that a company offering such medications will not effectively lose time from a five-year period under which it can exclusively market the drugs…Drug makers have griped they are often at a competitive disadvantage, since controlled substances must first be placed on the DEA list before they can reach pharmacies. Companies have complained the process is often lengthy and hampers their ability to take advantage of a five-year marketing exclusivity period following Food and Drug Administration approval during which generic competition is delayed…the Improving Regulatory Transparency for New Medical Therapies Act, would require the DEA to list a drug within 90 days after receiving notice from the FDA...

Bergen is the last stop on a global drug route that gives it one of the worst heroin problems in Europe…Now with a change in local government here and in the capital, Oslo, there is an appetite to use radical policies to curb the alarming number of Norwegians who die from heroin overdoses each year. Alongside traditional replacement therapies, such as methadone, the new left-wing local leaders want to use a medical form of injectable heroin [diamorphine] to treat the most at-risk users…The official goal is to wean them off the drug entirely, but even the most ardent supporters admit the most achievable target is to bring them within a safer environment, while helping to tackle the crime associated with heavy drug use…Norway has the worst heroin mortality rate in Western Europe...

…ex-CFO (James Canedo ) of the now-defunct Pacific Hospital in Long Beach, Calif., was among those who recently reached a plea agreement with prosecutors for his involvement in a fraud scheme that generated $580 million in false billings…The 15-year-long fraud scheme involved…submitting bills to workers' compensation insurers and the U.S. Department of Labor for spinal surgeries. The surgeries were performed on patients who had been referred by dozens of physicians, chiropractors and others who were paid illegal kickbacks…More than $580 million in bills were fraudulently submitted by Pacific Hospital during the last eight years of the scheme alone. [California Pharmacy Management and its successor, Industrial Pharmacy Management, were also important players in the scheme. Both companies set up and managed what were essentially mini-pharmacies within doctors’ offices.]

European Medicines Agency has published a good practice guide on medication errors to improve the reporting, evaluation and prevention of medication errors by regulatory authorities and pharmaceutical industry throughout the EU…The…guide on medication errors published today complements the guideline on good pharmacovigilance practices…It consists of two parts:

• details how suspected adverse reactions that are caused by medication errors should be recorded, coded, reported and assessed. The goal is to improve reporting and to learn from medication errors for the benefit of public health.
• clarifies key principles of risk management planning in relation to medication errors. It describes the main sources and types of medication errors and proposes options to minimise the risk of medication errors throughout the lifespan of a medicine.

…the Orphan Drug Act was passed to give drug makers incentives to create medicines for rare diseases, which are defined as maladies that affect fewer than 200,000 people. The incentives include tax credits and seven years of marketing exclusivity. Since then, more than 400 orphan drugs have been approved by the Food and Drug Administration. Last year, though, 41 percent of all FDA approvals were for orphan drugs. And sales of orphan medicines, which carry high price tags, are forecast this year to total $107 billion…team of researchers argues that drug makers are exploiting loopholes that allow them to widen the market for such drugs and distorting the original purpose of the law. We spoke with Martin Makary, a cancer surgeon and professor of health policy at Johns Hopkins School of Medicine…

Food and Drug Administration says it plans to make an announcement on the birth control device Essure in February 2016, after the agency completes a "high priority" review of the device's safety…The agency is also considering a recent MDEpiNet study…found women who received Essure had a "more than 10-fold higher risk of undergoing reoperation," when compared to women who had laparoscopic sterilization…Essure is a permanent birth control device…marketed by Bayer…Essure was first approved...in 2002 under FDA's premarket approval process…In recent years Essure has been surrounded by controversy as patients and activists have claimed the device has caused serious and debilitating side effects… Others have claimed the device is not as effective as it claims…in November, Representative Mike Fitzpatrick introduced a bill titled the E-Free Act directing FDA to pull Essure's PMA within 60 days of the bill's passage. So far the bill has four co-sponsors, including Reps. Marsha Blackburn, Christopher Smith and Lou Barletta.

Executives with Arizona's nonprofit health insurance co-op said Tuesday that they have failed to come up with additional financial backing and the insurer plans to shut down all operations Dec. 31…The announcement by Meritus Health Partners means 59,000 Arizonans it now covers need to find a new insurer by Dec. 15…The decision comes nearly a month after the state Department of Insurance suspended its right to sell new policies or renew current ones and placed it under formal supervision… The nonprofit was one of 23 co-ops created under the Affordable Care Act to provide competition to for-profit insurers, but many have struggled and more than half have now failed or will close by the end of the year.

For the 2.5 million people living with epilepsy… medications can help control their seizures — most of the time. But some suffer unpleasant side effects from the drugs. And a few remain at risk of death…Researchers at the Johns Hopkins University hope to help those with the neurological condition by collecting information about their seizures through their…Apple Watches…"Physicians often ask patients to record their seizures, but that can be hard, especially when a patient loses consciousness," said Dr. Gregory Krauss…who is working on the program, named EpiWatch…collects data that help researchers better understand epilepsy, while helping patients keep a more complete history of their seizures," he said…The data could not only help doctors adjust an individual's treatment to make it more effective and less burdensome, but could also help...counter sudden unexpected death, a danger some face from seizures.

Food and Drug Administration should allow the importation of pharmaceutical products from Canada if they meet certain stipulations, Sens. Chuck Grassley and John McCain wrote in a letter to Health and Human Services Secretary Sylvia Burwell… senators call on FDA to “immediately” certify the importation of prescription drugs

• if they are off patent and are no longer marketed by the drug developer,
• if there are “significant and unexplained” price increases,
• if no direct competitor product is currently marketed and the introduction of a new drug will benefit US consumers, or
• if the drug is “produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.”

Drugs could also be imported from countries outside of Canada “with similar regulatory regimes related to drug approvals,”…As far as how FDA could go about allowing such imports, the senators point to the Medicare Prescription Drug, Improvement and Modernization Act of 2003 that allows FDA to permit pharmacists and wholesale retailers to import drugs from Canada.

Bradley Bender, Southampton Town Councilman, pleaded guilty today to conspiring to illegally distribute oxycodone…Bender received phony prescriptions for oxycodone from a Riverhead physician assistant, Michael Troyan, filled those prescriptions, and illegally exchanged the oxycodone pills for cash and steroids with another co-conspirator. The oxycodone pills were then re-sold to drug abusers…“Councilman Bender’s actions in this oxycodone distribution conspiracy victimized the very community he was entrusted to represent…guilty plea should serve as a reminder that no one is above the law, including those entrusted with passing our laws.”