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Two compounding pharmacists from Alabama will spend a year in prison for distributing tainted drugs... The adulterated drugs were compounded at Advanced Specialty Pharmacy, which did business as Meds IV... David Allen...and William Timothy Rogers...pleaded guilty...to 2 misdemeanor violations of the Federal Food, Drug and Cosmetic Act...the 2...were sentenced to 12 months and 10 months in prison, respectively...also...1 year of supervised release after they get out of prison, and they’ll each have to pay a $5000 fine...Meds IV compounded...its own amino acid solution, then mixed it with other ingredients to create TPN (Total Parenteral Nutrition)...The amino acid solution happened to be contaminated with Serratia marcescens, and the TPN was prepared, packed, or held in insanitary conditions...the amino acid was prepared by Meds IV outside a laminar airflow workbench and was kept unrefrigerated, in a room that was not sterile, in a large pot sitting on the floor, sometimes overnight, before it was sterilized and used...Nine patients developed bloodstream infections and died, while others developed S. marcescens bloodstream infections but survived.

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.

Gilead Sciences won regulatory approval...to sell a new hepatitis C combination drug, which can combat all six strains of the disease, and priced it below its older treatments...Epclusa, combines the older Sovaldi (sofosbuvir)medication with the newer velpatasvir, and costs $74,760 for a 12-week course of treatment, although that’s before any rebates are offered to payers. This is less than the list prices for both Sovaldi and Harvoni, another Gilead hepatitis C treatment...Gilead has argued its treatments are more affordable than paying for liver transplants, cancer, and hospitalizations. To what extent the newest drug will cause payers concern is unclear. Epclusa will cost roughly half of the most commonly used treatment regimen for patients with Genotype 3 of the disease...(which)...is...the most difficult to treat and one of the reasons Epclusa was granted priority review by the FDA...One consumer advocate charged the pricing for the new drug was out of line...Gilead still doesn’t get it — their pricing is outrageous. Once again, Gilead has shown that it is more concerned with protecting its profits rather than making its drugs available to all Americans...

A divided U.S. Supreme Court...rejected an appeal filed by pharmacists in Washington state who objected on religious grounds to providing emergency contraceptives to women...The justices, with three conservatives dissenting, left in place a July ruling by the San Francisco-based 9th U.S. Circuit Court of Appeals that upheld a state regulation that requires pharmacies to deliver all prescribed medicines in a timely manner...In Washington, the state permits a religiously objecting individual pharmacist to deny medicine, as long as another pharmacist working at the location provides timely delivery. The rules require a pharmacy to deliver all medicine, even if the owner objects...Alito said there is evidence the regulation was adopted because of "hostility to pharmacists whose religious beliefs regarding abortion and contraception are out of step with prevailing opinion in the state."..."If this is a sign of how religious liberty claims will be treated in the years ahead, those who value religious freedom have cause for great concern," Alito added.

Renown Health is paying $9.5 million to settle allegations of Medicare fraud after its former compliance director-turned whistleblower accused management of encouraging "systemic" overcharging — and sometimes double-billing — of hundreds of patients...U.S. Attorney Daniel Bogden announced the settlement agreement...between the Justice Department and...Renown Regional Medical Center, the largest hospital and health care network in northern Nevada with more than $1 billion in annual revenue...Cecilia Guardiola, a registered nurse and law school graduate, said in a federal whistleblower lawsuit filed in 2012 that she began to discover the "billing deficiencies" shortly after Renown hired her as its director of clinical documentation in June 2009...

A team of JAMA authors urged the FDA in 2014 to add "black box" warnings to dopamine agonists, linking the Parkinson's meds to pathological gambling, compulsive shopping and sexual obsessions...Public Citizen is upping the ante with a citizen petition to the agency, citing more than 80 studies supporting its claims...Public Citizen’s petition calls for stronger warnings on six FDA-approved medicines including GlaxoSmithKline’s Requip, Boehringer Ingelheim’s Mirapex and UCB’s Neupro. Used to treat Parkinson’s disease and restless leg syndrome, the medicines can cause uncontrollable urges that in turn lead patients to divorce, financial ruin and suicide attempts…

Drug makers generally don’t complain when regulators widen the market for their medicines. But AstraZeneca filed a lawsuit...claiming the Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition...The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8...the drug maker won FDA approval to sell Crestor to treat children with a rare genetic disorder called homozygous familial hypercholesterolemia...Under the Orphan Drug Act, the company was awarded an additional seven years of marketing exclusivity for Crestor, but only for treating this particular rare...disease...Several generic companies are lined up to sell a version of Crestor. AstraZeneca argues that a generic must include all pediatric labeling information approved for the corresponding brand-name drug. The company filed its lawsuit over concerns that the FDA will, instead, rely on a decision it made last year allowing generic companies to exclude certain information, so long as a safety risk is not created...AstraZeneca...believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US...the American Journal of Clinical Oncology, a team of researchers argued that drug makers are exploiting loopholes in the Orphan Drug Act that allow them to widen the market for such drugs and distorting the original purpose of the law.

...two Chinese companies　with ties to Western drugmakers have been called on the mat to account for problems in their manufacturing. The FDA has issued warning letters to plants operated by Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical, slamming them both for manipulating testing and turning in falsified batch test results on APIs...

• Shanghai Desano Chemical Pharmaceutical - FDA...criticized the facility for conducting "unofficial" tests of drug batches that it kept out of its official record...also disturbed by finding many electronic logs of production deviations in a folder titled "GMP Anomalies" that had never been investigated…
• Chongqing Lummy Pharmaceutical...FDA...warning letter slams the drugmaker for widespread and serious data manipulation of batch analyses...In one egregious case, the FDA...an analyst set the gas chromatography personal computer clock back to make it appear as if testing had been done...7 months earlier. The analyst then performed 5 injections to produce falsified results for long-term stability for a finished API lot, deleted four and reported only the results of the final injection as passing in the quality-control...

Drug Enforcement Administration released the 2016 National Heroin Threat Assessment Summary – Updated...The report outlines the expanding public health crisis afflicting America due to the use and abuse of heroin and other opioid drugs. Some key facts:

• The number of people reporting current heroin use nearly tripled between 2007 (161,000) and 2014 (435,000).
• Deaths due to synthetic opioids, such as fentanyl and its analogues, increased 79 percent from 2013 to 2014.
• Deaths involving heroin more than tripled between 2010 (3,036) and 2014 (10,574) – a rate faster than other illicit drugs.

A new way to curb the proliferation of prescription painkillers in West Virginia is in the works: "Prescriber report cards."...The state Board of Pharmacy is developing a system that will rank doctors by specialty based on the number of prescriptions they write for pain medications..."We’re going to categorize prescribers, and then send notifications of how they rank among their peers with their prescribing practices," said Michael Goff, a pharmacy board administrator. "It’s a way of telling them, ‘Hey, among other doctors in your field, doctors who do what you do, here’s where you rank.’"...One drawback: The report cards won’t be made public. State law requires such information to be kept confidential. Doctors would only see their own numerical ranking, not a complete list of rankings by specialty...