Reports: SCOTUS to take up branded-generic patent settlements
NEW YORK — The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients’ access to cheaper drug treatments, according to published reports.
Politico reported that the justices had agreed to hear three cases, including Federal Trade Commission v. Watson Pharmaceuticals, involving settlements between branded and generic drug companies that critics deride as "pay-for-delay" deals.
Typically, when a generic drug company wants to be the first to market a generic version of a drug, it will file for Food and Drug Administration approval for it before the branded drug has lost patent protection. This usually prompts a lawsuit from the branded drug company, and while the suits often go to trial, in many cases, they will result in a settlement that allows the generic drug maker to launch at a later date.
While the "pay" part of the deal may be monetary, it frequently consists of a promise on the part of the branded drug maker not to market an authorized generic — essentially the branded drug marketed at a discount under its generic name, usually by a third-party company — during the 180-day market exclusivity period to which generic companies are entitled if they are the first to win approval for a generic, when they have the sole right to compete against the branded version.
The FTC estimates that the deals raise the cost of drugs by $3.5 billion per year, while drug companies say that the deals get drugs into the hands of consumers faster than they would if the patent-infringement suits went to court, and that delaying the launch of a generic drug beyond patent expiration would be illegal anyway.
Industry trade groups like the Generic Pharmaceutical Association and the Pharmaceutical Research and Manufacturers of America have defended the deals, while others, such as the American Medical Association, have come out in favor of legislation to make them illegal, as the AMA did in a statement last month.
Biotech company acquires vaccine from Pfizer
EXTON, Pa. — Biotech and vaccines company Nuron Biotech has bought rights from Pfizer for a vaccine to prevent infection by a bacteria that is a major cause of infectious disease around the world.
Nuron said that it acquired the rights to Meningitec, used to prevent invasive disease caused by Neisseria meningitidis serogroup C., a major cause of diseases such as meningitis, sepsis and pneumonia. The bacteria live without causing symptoms in the nasopharynx in about 10% to 25% of the population, but may cause disease if they enter the bloodstream through the nose and throat. The bacteria is estimated to cause 500,000 cases of disease worldwide each year with a 10% to 20% fatality rate, a rate that can climb to 90% without treatment; up to 19% of survivors have hearing loss, brain damage, renal failure and limb amputations.
"Meningitec is a tremendous opportunity to expand Nuron Biotech’s portfolio with a commercially successful vaccine within an established market," Nuron Biotech CEO Shankar Musunuri said. "The addition of Meningitec represents an important milestone toward bringing innovative biologics and vaccines to patients with unmet needs around the world."
RxAlly’s pharmacy advocates find their clinical-care champion
If you’re a student working toward a degree in pharmacy, or a practicing pharmacist, here’s something you can feel good about. The expanding army of pharmacists working to advance patient care, lower health costs and integrate the nation’s fractured health system has found a true champion to lead its clinical-care efforts.
Rebecca Chater, the highly regarded pharmacy leader and EVP in charge of Kerr Drug’s clinical services division, Kerr Health, has become VP-health outcomes at RxAlly, the national network of more than 22,000 chain and independent pharmacies working to advance patient-care services and cost-effective solutions for patients and health plan payers.
According to the group’s CEO, former National Community Pharmacists Association chief Bruce Roberts, Chater will help “develop and implement on a national scale industry-leading clinical service programs that support RxAlly’s member pharmacies in providing the highest quality pharmacy care available.” Roberts rightly enthuses about Chater’s “impressive credentials…and her genuine passion for enhancing the value of community-based, patient-focused quality pharmacy care."
By its own description, RxAlly is “creating a solution that transforms an outdated approach to pharmacy care into one that can benefit all of us.” Its message to patients, both in print and online, is that the tens of thousands of pharmacists who now embrace its mission are taking “a greater role in coaching and customizing a care plan.
“They coordinate refills, reconcile medications, give you tools to make taking and managing your prescriptions easier, and offer clinical services like adult and adolescent immunizations and blood pressure and other health testing – all in collaboration with the rest of your help care team,” RxAlly tells patients.
The underlying message to both patients and health plan payers, says the organization, “is to make a significantly measurable difference in health outcomes and health care costs.” That mission – and that vision for a fully engaged and patient-focused brand of pharmacy practice –defines perfectly what the new chief of health outcomes is about.
Rebecca Chater has been one of pharmacy’s most prescient, determined and visible proponents of pharmacy-based clinical care for two decades. As the long-serving head of clinical-care initiatives at 77-store Kerr Drug, itself one of retail pharmacy’s boldest innovators in patient care and preventive-health services, Chater has been a tireless champion for a higher level of pharmacist practice. She’s also past president of the North Carolina Board of Pharmacy and has served as visiting clinical professor in pharmacotherapy at the University of North Carolina’s Eshelman School of Pharmacy.
Her enthusiasm is infectious. I’ve had the pleasure of knowing Rebecca for a decade or more, and every time we meet or speak by phone, I’m charged up with a renewed sense of community pharmacy’s still-untapped potential as a critically important part of a smarter, more cost-effective and more patient-centric U.S. health system.
“RxAlly’s goal is to empower community pharmacies to provide personalized pharmacist care to improve health outcomes and lower health care costs, so it’s a perfect fit with what I have been focusing on professionally for a long time,” said the Kerr veteran.
So congrats on your new role, Rebecca Chater, and good luck. RxAlly – and the quest for a full seat at the health care table for retail pharmacists – are in good hands.