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The Colombian government and Novartis appear to be headed toward a showdown over the widely used Gleevec cancer treatment. In the latest twist, Health Minister Alejandro Gaviria is giving the drug maker a few more weeks to reduce its price for the medicine, or he will issue a so-called "compulsory license" that will allow generic companies to sell lower-cost versions...For us, it’s a question of survival...The ultimatum comes amid heightened tension over the government’s plan to widen access to the medicine...Novartis has consistently maintained that it is "actively seeking a resolution" to the dispute, while arguing that compulsory license should not be used to force price negotiations. The company has also insisted that the price for Gleevec in Colombia is subject to government controls and that generics are available in the country...The episode has quickly become another heated example of the clash over intellectual property rights and access to medicines between the pharmaceutical industry and cash-strapped governments. Global drug makers argue that compulsory licenses should be reserved for public health emergencies and as a measure of last resort, not a tool to use in negotiations for a lower price...

Two recently released reports from the University of Nevada School of Medicine say Nevada has remained near the bottom of many health care rankings partly because of population growth...The 2016 editions of Physician Workforce in Nevada and Health Workforce Supply in Nevada...offer insight into the state’s health care workforce, including what researchers say is the importance of education and training opportunities in meeting the state’s health care needs...Nevada falls well below the national rates of medical doctors per 100,000 members of the population and doctors in patient care per 100,000 population...Nevada has seen increases in the number of health care practitioners in many fields, but that growth isn’t reflected in per capita numbers because of the state’s growth...Per capita, Nevada ranks 48th in the nation in physicians and 50th in primary care physicians...Trying to keep up with the demand is a real challenge, so that’s part of the issue...Another part of the issue is that in order to educate the health care workers of the future, you have to have clerkships and internships for them in the state....

The fight over how biosimilars should be named in the US isn’t over yet despite the Food and Drug Administration’s use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars...The group of nonprofits and other stakeholders, spearheaded by the Alliance for Safe Biologics, requested in a letter that FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used with the first biosimilar approval for Zarxio (filgrastim-sndz). The group said meaningful suffixes are preferable to the random suffixes described in the FDA’s draft guidance on biosimilar naming...In that draft guidance, FDA said the meaningless suffixes will help prevent inadvertent substitution (which could lead to medication errors) of biologics that are not determined to be interchangeable by the FDA..."Meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products."

Moves in Congress to link billions of dollars in new medical research funding to revised standards for drug and medical-device approvals are troubling some public-health experts, who say the combination makes it too easy for lawmakers to support lower patient-safety standards...These safety advocates say legislation to beef up research funding for the National Institutes of Health should be separated from product-approval changes at the Food and Drug Administration..."This is the first time this has been done this way, and it’s a deal with the devil," said Dr. David A. Kessler, onetime FDA commissioner during the 1990s under presidents of both parties. "It’s time to uncouple the promise of research funding from the requirement that FDA standards be lowered."...To its supporters, linking NIH funding with FDA bills (21st Century Cures Act)—including changes to approvals of antibiotics and some medical devices—produces innovation in life-saving products and research. Politically, it is a classic Washington bargain that has something for everyone...The new FDA commissioner, Dr. Robert M. Califf, said in a recent talk that "this legislation, if not carefully crafted, could pose significant risks for FDA and American patients…Innovative therapies are not helpful to patients if they don’t work, or worse, cause harm," he said...

...anesthesiologist Jaime Guerrero, who had practices in Kentucky and Indiana, was sentenced to 100 months in prison...according to...plea agreement, Guerrero agreed to forfeit his license to practice medicine, and to forfeit real property owned by Guerrero Real Estate Investments...Further, Guerrero agreed to pay $827,000 in victim restitution to nine health care benefit programs...pleaded guilty to 31 counts of a 35 count Superseding Indictment...including unlawful distribution or dispensing of controlled substances, health care fraud, conspiracy and money laundering...Guerrero conspired with others to knowingly and intentionally distribute and dispense Schedule II and III controlled substances to patients, without a legitimate medical purpose and beyond the bounds of professional medical practice... Guerrero...fraudulently submitted over 100 claims to various health care benefit programs for office visits at a higher code than the service provided; for office visits that were not medically necessary or within the course of usual medical practice; submitting claims for services that were not sufficiently documented in the patient’s medical record; and making claims for office visits as though a physician saw the patient...

Dr. Robert Rand did not enter a plea during his appearance in federal court Monday in Reno...Rand has been indicted and charged with taking part in a criminal prescription drug distribution ring...His attorney, John Arrascada, told News 4 that Rand would plead not guilty to all charges...Eight other people have been indicted by a federal grand jury. All eight have pleaded not guilty to the charges they face individually, though only Richard Winston West II remains detained...Doctor Robert Rand will be arraigned...to enter a plea on charges of conspiracy to distribute and possess with intent to distribute controlled substances...

Pfizer Inc has taken steps to ensure that none of its products are used in lethal injections..."We are enforcing a distribution restriction for specific products that have been part of, or considered by some states for, their lethal injection protocols," the...drugmaker said on its website. "Pfizer strongly objects to the use of its products as lethal injections for capital punishment."...The move shuts off the last remaining open market source of drugs used in executions, following similar actions by more than 20 U.S. and European drugmakers, according to a report in the New York Times...Pfizer’s distribution restriction limits the sale of the seven products to a select group of wholesalers, distributors, and direct purchasers under the condition that they will not resell these products to correctional institutions for use in lethal injections, the company said.

A public health campaign in Vermont is getting naloxone into the hands of those who may need it, and pharmacists at the state's major academic medical center are doing their part to help...a pilot program operated by the Vermont Department of Health distributed 8723 "naloxone rescue kits" or kit refills from a network that now includes 10 sites around the state...The sites, which are operated by drug treatment, harm reduction, and recovery centers, get the kits at no cost from the health department and distribute them to patients who are at high risk for an opioid overdose. Friends and family members may also pick up the kits...Meghan Groth, emergency department pharmacist at the University of Vermont Medical Center...developed a similar protocol for dispensing naloxone rescue kits to patients in the ED...Mark DiParlo, manager of UVMC's outpatient pharmacies, expects to have a pharmacy-based naloxone dispensing plan in place by summertime...

Leading UK charities have written to Prime Minister David Cameron urging a review of the system for commissioning drugs in England and Wales which, they argue, has put thousands of cancer patients at risk of missing out on the most innovative therapies...In an open letter to the Prime Minister...the heads of leading cancer charities warn that plans to leave the appraisal methodology employed by the National Institute for Health and Care Excellence unchanged will soon lead to effective new cancer medicines struggling to gain approval...Under current government proposals the Cancer Drugs Fund’s assessment of medicines will be handed back to NICE..."We must not forget the CDF was established as an emergency measure to bypass the very NICE appraisal process to which it is now returning because it was not working for cancer patients," the charities said, and called for "a sustainable system, flexible enough to ensure that the best cancer drugs can routinely benefit NHS patients"...With an anachronistic NICE system still unable to engage in price negotiation, it’s inevitable that patients will not be able to access the clinically-proven medicines that could mean so much to them...it is "high time" for a review of the system.

It is "highly uncertain" how much money the state of California would save if a ballot measure to cap drug prices passes in November — and it might not save money at all. That’s the key finding in a preliminary report by the Legislative Analyst’s Office...The ballot initiative, known as the Drug Price Relief Act, would prohibit the state from paying more for a prescription drug than the lowest price paid by the U.S. Department of Veterans Affairs...But the financial impact on the state is unclear, the analyst’s office said, for two reasons.

• One, the lowest prices paid by the VA are not known and there’s no guarantee they will be revealed to the public — or to state officials.
• Two, it’s unclear how drug companies would react if the measure became law: The companies might, for example, raise prices on the VA, nullifying the intended effect.

"This measure is misleading and unworkable," Hollaine Hopkins, executive director of the Lupus Foundation of Southern California, said in a prepared statement. "It will lead to increased red tape and bureaucracy, and could actually increase costs for the state’s taxpayers."...Opponents of the measure had raised more than $58 million as of May 4, according to the California Fair Political Practices Commission. The AIDS Healthcare Foundation has raised a little more than $4 million in support of the initiative.