Author: Peter

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 way we pay for prescription drugs is more complex than the way we pay for anything else in the health system...When we pay for innovative medications...we’re not paying just for the pill – we’re paying a high price to incentivize the 10 years of clinical research needed to get that drug through the FDA approval process, and all the failures along the way. This high price is often negotiated down by various middlemen, but it nevertheless remains a "monopoly price." Patents, along with FDA-granted market exclusivity, preclude competitors from marketing the same drug under the same or different name for a period of time...the U.S. doesn’t have any national, price controls, profit controls, or other active or passive forms of across-the-board price regulation. This makes the American drug market unique, both in its strengths and weaknesses. Drug pricing reform should ideally protect those strengths while minimizing the weaknesses...

The state's first public medical school launched its new look...complete with updated logo and branding identity. The University of Nevada, Reno School of Medicine on July 1 officially added "Reno" to its name after a decades-long history of being the University of Nevada School of Medicine…"An organization's branding is far more than a name or logo; branding is the perception of our school in the minds of our many constituents," said Thomas L. Schwenk, M.D., dean of the University of Nevada, Reno School of Medicine. "Our new name and logo represent the stunning and positive changes taking place as we build a full clinical, teaching and clinical research campus in Reno. The School of Medicine has not gone through a transformational change of this magnitude since its founding, and the branding campaign is our opportunity to share this exiting story widely."...The changes more closely align the School of Medicine with its parent university, the University of Nevada, Reno. The new branding also further clarifies the school's affiliation, location and distinct role in the state...

...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…

A major food allergy advocacy group said this week that it would stop accepting donations immediately from drug companies selling epinephrine auto-injectors until there is “meaningful competition” in the market...While not mentioning Mylan by name, the statement from Food Allergy Research and Education implies that the EpiPen manufacturer is one of the targets. Mylan is the only one of FARE’s corporate sponsors that currently markets epinephrine auto-injectors. The organization...would not specify the exact amount of money that Mylan has donated to FARE, and the statement did not address how it would make up the lost donations...The organization has been actively involved in efforts across the country to expand access to epinephrine auto-injectors in public places like schools...

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…

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...

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.

Shares of Kroger were lower Wednesday. The supermarket chain has emerged as a buyer for stores of Rite Aid. The drugstore chain is close to being acquired by Walgreens Boots Alliance, but Rite Aid would have to sell off overlapping assets in order to appease regulators. Kroger looks to be the potential buyer for all of Rite-Aid's overlapping stores considering that it is well capitalized and has experience running pharmacies in its stores.

Mylan Pharmaceuticals is facing two lawsuits relating to its pricing of EpiPen treatments for life-threatening anaphylactic shock...One suit…in an Ohio...alleges that the company’s price increases — which brought the list price up to about $600 for two EpiPens — violated the state’s consumer protection law..."Defendant has a legal duty and obligation to set a fair, affordable, and reasonable [price] and not hold consumers hostage by forcing them to pay exorbitant prices for its medically necessary product," the complaint states...Another lawsuit was filed...in Michigan and focuses on Mylan’s practice of selling EpiPens in the United States only in packs of two. The plaintiffs allege that Mylan packages EpiPens that way for marketing reasons, not for health and safety reasons..."Defendants have misstated the science regarding, and regulatory framework governing EpiPens in order to require consumers to buy extra, unneeded EpiPens, which are likely to go to waste, at an inflated cost," the complaint states...Mylan is also the subject of investigation by the New York Attorney General for potential antitrust violations...