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Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

Walgreens Boots Alliance said U.S. antitrust regulators are requiring a divestiture of between 500 and 1,000 retail stores if its acquisition of Rite Aid will be approved...In the Walgreens-Rite Aid deal, it’s the Federal Trade Commission that is evaluating the transaction and demanding divestitures if the deal is going to win approval...Despite the large divestiture of stores, Walgreens expects the deal to still close in the second half of this year leaving the company with more than 11,700 U.S. stores. Walgreens has 8,200 U.S. stores and Rite Aid has 4,500. Even a divestiture of up to 1,000 stores would make Walgreens larger than CVS Health and its 9,600 pharmacies ...Walgreens chief executive officer Stefano Pessina has vowed to be a consolidator in a U.S. market he sees as facing more government control of pricing thanks in part to broader health coverage under the Affordable Care Act. The U.S. also has a growing population of aging baby boomers gaining Medicare coverage.

The government has pushed the pause button on plans to implement a 6 percent cut to community pharmacy funding from October...In a speech to the Royal Pharmaceutical Society's Annual Conference, Pharmacy Minister David Mowat explained that the delay is to "make sure that we are making the correct decision and that what we do is going to be right for you, right for the NHS and right for the public."...Earlier this year, the Local Government Association - which represents more than 370 councils – warned that community pharmacies are at risk of going out of business because of planned budget cuts, which could potentially pull the plug on a vital lifeline for many elderly and vulnerable patients...Sandra Gidley, Chair of the RPS English Pharmacy Board, also welcomed the Minister's speech, noting: "I am heartened that a second look is being taken at the proposed community pharmacy cuts and that the Minister has recognised the strength of public feeling on the issue"...Around 1.6 million people visit pharmacies every day for treatment and advice, and there is widespread belief that the service could play a much greater role in helping to address some of the NHS' current challenges...

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

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

To protect patients, pharmaceutical manufacturers must monitor any adverse events we hear about with respect to the drugs we produce and report those adverse events to the Food and Drug Administration, as required by law...Developing and maintaining an accurate safety profile of a product is a joint responsibility between the manufacturer of the product, the FDA and consumers...As noted, reporting of adverse events to the FDA is a critical component of the patient safety protection system...While some compounding pharmacy adverse events are now haphazardly reported — FDA just last week sent warning letters to drug compounding pharmacies in Tennessee and Virginia following reports — there is a giant gap in that system that may put patients at risk —adverse events with respect to drugs made by compounding pharmacies are generally not required to be reported to anyone...Regardless of how quickly states work to improve their oversight of sterile compounding, an immediate step should be to require reporting of adverse events. If states do not act to require this kind of reporting, Congress should step in and mandate it. Until then, patient safety is at risk.

...Walgreens Boots Alliance and Prime Therapeutics rolled out a highly innovative partnership. It could have wide-ranging implications...This novel union aligns a pharmacy benefit manager, retail pharmacy chain, and health plans via joint ownership of a new mail and specialty pharmacy company. If executed properly, it will be a best-of-breed business model that could reshape the PBM and pharmacy industries. For manufacturers, organized customer management just got even more complicated...The new business could also pose a serious challenge to pure-play PBMs that lack a health insurer partner or an economically-aligned retail dispensing channel…

Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care, From the Managed Markets News Network.

The FDA’s Office of Criminal Investigations has spent thousands of hours pursuing foreign-imported, mislabeled drugs. But more than half of all OCI cases end without charges, and critics contend the agency’s efforts protect drug makers as much as consumers...On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic...West was chasing a lead that Dr. Anindya Sen...purchased an unapproved...cancer drug Avastin...Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging…A...judge later said West’s...statement about the drugs being counterfeit "apparently was not the truth." West’s search was declared illegal, and the evidence was deemed inadmissible…Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching…

Paul LeVine, vice president of Analytic Services at TrialCard, discusses how specialty pharmacies can best utilize data to improve patient outcomes.