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European and U.S. pharmaceutical associations have waded into a diplomatic row between Germany and Saudi Arabia, warning that ongoing restrictions on German-made drugs could hurt Saudi patients and dampen future investment in the kingdom...In a strongly worded letter to Crown Prince Mohammed bin Salman....he associations highlighted the level of concern in Germany and elsewhere about restrictive procurement measures implemented by Riyadh in response to criticism of its policies...Germany’s foreign minister at the time, Sigmar Gabriel, condemned “adventurism” in the Middle East in comments perceived by some as an attack on increasingly assertive Saudi policies. Riyadh dismissed the comments as “shameful” and withdrew its ambassador to Germany...“For the past six months German healthcare companies have been having trouble doing business in Saudi Arabia,” said Oliver Oehms of the German chamber of commerce and industry in Riyadh. “It is not a general boycott, but the healthcare sector is clearly suffering.”...Saudi Arabia is the largest pharmaceuticals market in the Middle East and Africa, with sales of $7.6 billion last year, according to healthcare information company IQVIA...With a growing burden of chronic diseases tied to a more Western lifestyle, Saudi Arabia’s overall drugs market is growing at 10 percent a year and the tender sector is expanding by about 30 percent.

The Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto-injector for severe allergic attacks, including life-threatening anaphylaxis....The EpiPen was approved in 2007 and is marketed by Mylan. However, since then both the company and its product have been involved in a number of scandals. Notably the price of the EpiPen has increased from $57 in 2007 to approximately $600 in 2016 and in May, the FDA had to place Mylan’s EpiPen on its official shortages list as a result of manufacturing delays...The newly approved generic epinephrine auto-injector will be available in 0.3mg and 0.15mg strengths and is marketed by Teva. This the company’s second attempt to get its generic approved by the FDA; it was rejected in 2016...FDA commissioner Scott Gottlieb said: “Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the US is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval.

The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment...a first-of-its-kind RNA-based therapy for treating peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients...Polyneuropathy caused by hATTR is a rare, debilitating, and often fatal genetic disease characterized by the buildup of abnormal amyloid protein in peripheral nerves, the heart, and other organs...“This approval is part of a broader wave of advances that allows us to treat disease by actually targeting the root cause, enabling us to arrest or reverse a condition, rather than only being able to slow its progression or treat its symptoms...“New technologies like RNA inhibitors that alter the genetic drivers of a disease, have the potential to transform medicine, so we can better confront and even cure debilitating illnesses.

The Washoe County school board may open bidding for the district’s multi-million-dollar healthcare contract, school officials confirmed...The contract has been a point of conflict between the district and local healthcare provider Saint Mary’s Medical Group, which has said it was unfairly excluded from the bidding process — potentially at the expense of the district’s employees...The current proposal being weighed by the school board is an exclusive 3-year contract with Renown Health and its insurance arm Hometown Health, the district’s current health care provider. That plan would raise the cost of health insurance premiums by 10 percent in 2019...It's unclear if the move to accept other healthcare proposals comes too late to curb potential premium increases for 2019.

U.S. appeals court...tossed a $3 million verdict against GlaxoSmithKline over the suicide of an attorney who took a generic version of the company’s antidepressant Paxil, finding the company could not be held liable for injuries allegedly caused by a generic copy...The case weighing whether brand-name manufacturers can be sued for injuries blamed on generic drug versions was closely watched within the pharmaceutical and legal industries...Under a 2011 ruling by the U.S. Supreme Court, generic drug companies cannot be sued for failing to provide adequate label warnings about potential side effects because federal law requires them to use the brand-name versions’ labels...decision follows a series of state court rulings in similar cases. The top courts of Massachusetts and California ruled brand-name manufacturers could be sued by generic drug users...West Virginia’s Supreme Court...rejected liability claims against brand-name manufacturers for alleged failures to warn over a generic company’s drug.

...the Centers for Medicare and Medicaid Services' proposed changes to outpatient services, including site neutral clinic visits, 340B policy changes and broadening the list of surgeries covered at ambulatory surgical centers, would generally be credit negative and hurt hospital margins.

• Changes include no longer paying more for clinic visits in off-campus hospital or provider-based department clinics compared to a physician's office...
• Proposed changes to the 340B policy could also impact certain hospitals...CMS lowered reimbursement for Part B drugs to the drug's average selling price, minus 22.5 percent from the ASP, plus 6 percent. CMS said this would save Medicare about about $1.6 billion...
• CMS has proposed adding some nonsurgical procedures to those covered at ambulatory surgical centers, which are located off-campus, but are not hospital outpatient surgery centers...

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

The Trump administration on Thursday proposed that U.S. drugmakers cut production quotas of the six most abused opioids by 10 percent next year to fight a nationwide addiction crisis....the U.S. Justice Department and Drug Enforcement Administration said the proposed cut would be in keeping with President Donald Trump’s effort to cut opioid prescription fills by one-third within three years...

Walgreens and the Dept. of Veterans Affairs are working together to improve coordination of care for VA-enrolled patients. Through the partnership...VA providers will be able to see the entire medication and immunization history of the VA-enrolled patient if they receive prescriptions and immunizations at Walgreens...“This arrangement is the first of its kind, and it’s a strong collaboration,” said VA Sec. Robert Wilkie. “Partnerships like this will help VA continue to improve the way we care for Veterans.”...The VA-Walgreens exchange eliminates the need for providers to gather medication history from patients who fill their scripts at Walgreens...