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Pfizer Inc's trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label...The FDA...expressed concerns about the collection and interpretation of data from a post-marketing study on the controversial drug...Pfizer has been trying to have the "black box" warning - which warns of psychiatric risks including suicidal thoughts, hostility and agitation - removed from the drug's label...the study...compared Chantix or...Zyban with a placebo or a nicotine patch in smokers with and without a history of psychiatric disorders, showed that the drug did not significantly increase the incidence of serious neuropsychiatric side-effects...FDA staff disputed the results, flagging inconsistencies in data collection and characterization of the severity of some side-effects...

A European Commission court upheld an antitrust fine that was imposed three years ago against Lundbeck and four other drug makers for allegedly conspiring to delay the availability of a lower-cost generic version of an antidepressant...The ruling...came in response to an appeal of a 2013 decision that found Lundbeck and the generic drug makers pursued a pay-to-delay deal that violated European Union anticompetition regulations. The European Commission had fined the companies a total of $165 million with Lundbeck ordered to pay the bulk of the fine, or about $105 million...Regulators argue these deals are anticompetitive, force consumers to overpay for medicines, and escalate costs to the overall health care system. In the United States, the Federal Trade Commission estimates such deals cost Americans about $3.5 billion annually. Drug makers counter that the deals are not only legal, but allow lower-cost generic drugs to reach consumers faster than if patent litigation continued...

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.

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

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.

There is a real need for patients to have information about out-of-pocket costs and clinical tools being used when it comes to their coverage. A new prescription drug search tool that includes information about cost sharing, prior authorization and step therapy will be available to residents of Washington, D.C., shopping for coverage during the upcoming open enrollment period. These types of tools are important for patients, enabling them to find the best health care plan to meet their needs...DC Health Link’s new offering will allow patients in D.C. purchasing private health insurance to input up to 10 prescriptions and see which plans cover their drugs and the cost sharing that goes with them...The new DC Health Link tool also improves transparency and information about deductibles. One feature allows people to clearly see plan details, including whether available plans have a separate drug deductible, whether a medication is subject to a copayment or coinsurance and copayment amounts and coinsurance percentages...While progress continues to make marketplace websites more consumer friendly, additional improvements are still necessary to ensure consumers have a clear understanding of the choices in front of them when picking a health plan...

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 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…

Celator Pharmaceuticals proudly displayed a large poster touting its experimental Vyxeos (CPX-351) medication as an effective salve for treating acute myeloid leukemia. The poster was, in fact, one of countless placards featured prominently on the exhibit floor at the American Society of Clinical Oncology meeting…the Celator poster managed to stick out...Vyxeos has not yet been approved to treat AML...Celator reported positive clinical trial results for the drug...But that’s not the same thing as having clearance to market a product. Unfortunately, that’s the impression regulators had after looking at the poster…As far as the Food and Drug Administration is concerned, Celator was, effectively, promoting a drug that was misbranded. And so the FDA sent the company (now Jazz Pharmaceuticals)...a letter to complain about its promotional behavior...From a public health perspective, these claims and presentations are concerning because they include representations in a promotional context regarding the safety and efficacy of an investigational new drug that has not been approved by the FDA...