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Shire filed a lawsuit in a federal court against Allergan, claiming anticompetitive practices in its reimbursement contracts with payers on the eye drug Restasis. It's the latest in a series of similar cases, and the verdicts could well upturn all pharma-payer negotiations...Shire makes a rival product, Xiidra, and its fight against Allergan challenges longstanding negotiation practices that many makers of follow-on products argue are stifling competition...The verdicts in these cases could well rewrite the rules that govern how drugmakers form contracts with payers...Any verdicts in favor of the antitrust arguments could make it easier for manufacturers of biosimilars and other products entering well-established markets to steal share from the incumbents...In Shire's case, it’s arguing that Allergan improperly entered into exclusive contracts for Restasis with Medicare Part D providers. Those exclusive deals prevent makers of rival dry-eye remedies from competing for patients, the suit said...

Last month, drugmaker Allergan announced that it has made a deal with a New York state American Indian tribe to help protect Restasis from competition, using the tribe’s sovereign immunity as a shield against patent challenges. The deal—the first such move by Allergan and, in the pharmaceutical industry, an unusual one at best—has unleashed a firestorm of criticism, including from lawmakers...Originally, patents on Restasis were set to expire in 2014. But Allergan filed more patents, covering the “specific formulation and the method of using” the product, that expire in 2024...Lawmakers and patient advocates, meanwhile, are concerned not only about the implications for Restasis but whether this will set a pharmaceutical industry precedent...The House Oversight committee wrote to Allergan Chief Executive Brent Saunders on Tuesday asking for documents and information regarding the deal...The agreement “may impair competition across the pharmaceutical industry and ultimately dissuade companies from pursuing less-costly generic alternatives to brand drugs,” according to the letter...Allergan said in a statement that it plans to comply with the information requests...patient advocates say they’re worried...Allergan’s sham patent transfer is an effort to circumvent the law to prevent a cheaper generic of Restasis to come to market,” said David Mitchell, the co-founder and president of the non-profit Patients for Affordable Drugs. “Patients will be hurt by this. Patients are being hurt by this. And it’s an outrage.”

The bullet wounds that University Medical Center trauma surgeon Dr. Jay Coates saw late Sunday night were to the head, chest, abdomen, legs and arms...“It was like we were in a war zone,” he said early Monday...“From our patients’ wounds, you could tell a high-powered weapon had been used.”...Despite that preparation, UMC medical personnel and others at Sunrise, Valley and St. Rose Dominican hospitals said the carnage...Stephen Paddock unleashed at the...country music festival adjacent to Mandalay Bay was beyond anything you could imagine. Patients arrived so fast that the surgeons and support personnel couldn’t begin to keep up...“It was controlled chaos, a combat medical hospital — blood everyplace,” said Dr. Dale Carrison, head of emergency...staff at UMC...UMC, Southern Nevada’s only Level I trauma center, received 104 patients. Other patients — the final number is still uncertain — were later transferred to the hospital from other medical centers that couldn’t handle the severity of the gunshot wounds...Sunrise Hospital and Medical Center, a Level II trauma center and the closest trauma center to the Strip, treated 214 patients, with at least 30 needing surgery. Fifteen patients died there. The Sunrise system’s other hospitals, Southern Hills and Mountain View, treated nine and eight patients, respectively...Gretchen Papez, a spokeswoman for the Valley Hospital System, said the network of hospitals received a total of 228 patients, eight of whom died. She provided this breakdown by individual hospital: Desert Springs, 105 patients treated; Spring Valley, 53; Henderson, 32; Valley, 29; Summerlin, six; and Centennial Hills, three.

Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Proponents argue that limits reduce the risk of addiction, but are they keeping pharmacists from caring for their patients?... As the opioid crisis worsens, pharmacies, pharmaceutical manufacturers, and legislators are scrambling to help solve the problem. Recently, those efforts have focused on limiting opioid supplies. But in the effort to prevent unnecessary medications, are pain patients getting left behind?...Express Scripts and CVS Caremark recently announced a seven-day supply limit, and PhRMA...supported a seven-day limit...one-size fits all approach and will supplant providers’ clinical decision-making and the needs of patients who have legitimate need for these medications...payer limits restrict patients with legitimate pain management needs from accessing opioids. Those limitations...will force patients not at risk of abuse or misuse to work with their prescriber and pharmacist—which will cost the health-care system and “significantly” impact patients with limited resources, physical restrictions, or transportation issues...

New Jersey...accused Insys Therapeutics Inc of engaging in a fraudulent scheme to boost sales of a fentanyl-based cancer pain drug, as Massachusetts announced a $500,000 settlement with the drugmaker to resolve similar allegations...The lawsuit by New Jersey Attorney General Christopher Porrino accused Insys of illegally directing its sales force to push prescriptions of Subsys for a broader range of patients than the opioid drug was approved for, and at higher doses...The lawsuit...alleged Insys also paid kickbacks, including sham speaker fees to medical practitioners to prescribe Subsys and defrauded insurers into paying for it...The lawsuit said Insys’ greed put hundreds of lives in jeopardy and led to the 2016 overdose death of a New Jersey woman who was prescribed Subsys to treat fibromyalgia.

The US Food and Drug Administration has been encouraging the adoption of continuous manufacturing techniques...and several companies recently offered the agency some suggestions to refine its work around the developing technology...continuous manufacturing allows companies to move more seamlessly and efficiently...Last week, FDA finalized guidance on how manufacturers can participate in the agency’s program to advance continuous manufacturing...And in a blog post, Michael Kopcha, director of FDA's Office of Pharmaceutical Quality, pointed to Vertex's cystic fibrosis drug Orkambi (lumacaftor/ivacaftor) and Janssen's HIV treatment Prezista (darunavir) as examples of companies successfully using continuous manufacturing after engaging with FDA's emerging technology team...Vertex Pharmaceuticals...noted several contradictions in how batch size is described in an FDA document and sought further clarity and certainty regarding FDA’s understanding and expectations regarding batch size...AstraZeneca...asked if FDA might consider harmonizing the assessment process of the changes relating to continuous manufacturing, including a mechanism by which there could be some mutual recognition across countries participating in the International Council on Harmonization. AstraZeneca also said it "does not see the need" for a full ICH guideline on continuous manufacturing, which the company says FDA has been supporting. But the European drug industry group known as EFPIA is suggesting a Q&A document based on ICH Q8 and AstraZeneca says it "concurs with that approach."

Medical cannabis classes will no longer be held at the University of Maryland-Baltimore...The...School of Pharmacy has cancelled plans to start offering medical cannabis classes this fall...The online classes covered cultivation, manufacturing, dispensing, and laboratory standards of medical cannabis. However, after consulting with the Maryland attorney general’s office, the University directed the School of Pharmacy to not offer the classes...“The decision is due to legal concerns about United States law, and does not reflect any school concerns about the substantive content of the course materials,” Alex Likowski, Director of Media Relations, Communications, and Public Affairs, told Drug Topics..., the federal Controlled Substances Act remains in effect...“Under the CSA, cannabis is treated the same as any other controlled substance without regard to any medicinal use.

Stephen Paddock, who killed at least 58 people and wounded hundreds more in Las Vegas...with high-powered rifles, was prescribed an anti-anxiety drug in June that can lead to aggressive behavior...Records from the Nevada Prescription Monitoring Program...show Paddock was prescribed 50 10-milligram diazepam tablets by Henderson physician Dr. Steven Winkler on June 21...Diazepam...studies have shown can trigger aggressive behavior. Chronic use or abuse of sedatives...can also trigger psychotic experiences...“If somebody has an underlying aggression problem and you sedate them with that drug, they can become aggressive,” said Dr. Mel Pohl, chief medical officer of the Las Vegas Recovery Center. “It can disinhibit an underlying emotional state. … It is much like what happens when you give alcohol to some people … they become aggressive instead of going to sleep.”

Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network