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

A report from the majority staff of the House Energy and Commerce Committee found that distributors, which fulfill orders for prescription drugs to pharmacies, failed to conduct proper oversight of their customers by not questioning suspicious activity and not properly monitoring the quantity of painkillers that were being shipped to individual pharmacies...The committee also found that the DEA did not properly use a database that aims to monitor the flow of powerful prescription painkillers from manufacturers to sellers, something that could have allowed federal agents — in real time —...The agency also curtailed enforcement of distributors...and infighting inside the agency affected the way cases were handled...

Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities...ottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products...

Walgreens and FedEx are teaming up...The companies have launched Walgreens Express, a service that will provide next-day delivery nationwide, as well as same-day delivery in select markets...Patients who are enrolled in Walgreens text alerts will get a text message notification when their qualifying prescriptions are ready. They can then follow a process to choose to have their prescription delivered the next day for a $4.99 fee...Walgreens said most prescription orders are available to be delivered by the next business day, it said some prescription benefit plans and insurance plans do not allow home delivery, encouraging patients to talk to a pharmacist with any questions.

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.

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

The drug maker Actelion Pharmaceuticals has agreed to a $360 million settlement stemming from an investigation into whether the company illegally funneled kickbacks through a patient-assistance charity...Actelion...makes expensive drugs to treat a rare lung condition, is the latest pharmaceutical company to settle federal inquiries into their ties to patient-assistance groups, including whether companies have used the patient programs to increase the price of their drugs...But federal anti-kickback laws prohibit companies from giving such financial assistance to Medicare and Medicaid beneficiaries because doing so is considered an inducement to buy their drugs. For years, drug makers have skirted those laws by instead donating to nonprofit charities, which then give the money to Medicare patients. Such arrangements are legal as long as there is no direct coordination between the pharmaceutical company and the nonprofit organization...Federal prosecutors said Actelion violated the law by collecting detailed data in 2014 and 2015 about the patients receiving help from a nonprofit, the Caring Voice Coalition, and using the data to budget for future donations. As a result, Actelion ensured that the money it donated would be used only to assist patients who used its drugs, and not competing companies’ treatments for the pulmonary condition.

An advisory panel to the Food and Drug Administration....recommended prescribing the opioid overdose reversal drug, naloxone, along with addictive painkillers...The recommendation of the panel underscores concerns about the growing opioid overdose epidemic...FDA studies found that co-prescribing naloxone to all patients who are prescribed painkillers could increase annual healthcare costs by $63.9 billion to $580.8 billion...I think co-prescribing is an expensive way to saturate the population with naloxone. The at-risk population is not necessarily the ones that are being prescribed new narcotics...

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.

Nevada could soon have almost twice as many marijuana dispensaries as it does now after the state issued 61 conditional licenses, although it’s not releasing details about who the winners of the potentially lucrative permits are...“We issued a number of state-level licenses in counties that have thus far declined to allow marijuana establishments,” said spokeswoman Stephanie Klapstein of the Nevada Department of Taxation, which regulates marijuana. “There’s a chance some of those licenses will not ultimately result in operational retail marijuana stores.”...License winners have one year to obtain local approvals and pass a final inspection from the tax agency before they are issued a final state license. At that point, the name of the dispensary will be published on the state list of open retail stores, which currently includes 65 dispensaries in five counties.