- FDA expected to announce new warning on Johnson & Johnson vaccine related to rare autoimmune disorder (msn.com)
The Food and Drug Administration is preparing to announce a new warning for the Johnson & Johnson coronavirus vaccine saying the shot has been linked to a serious but rare side effect called Guillain-Barré syndrome, in which the immune system attacks the nerves...About 100 preliminary reports of Guillain-Barré have been detected after the administration of 12.8 million doses of Johnson & Johnson vaccine in the United States, the Centers for Disease Control and Prevention said in a statement Monday. The cases have largely been reported about two weeks after vaccination and mostly in men, many aged 50 and older...READ MORE
- Pharmas’ return on $5B spent yearly on patient support programs? Only 3% are using them: survey (fiercepharma.com)
Talk about a meager return on investment. Pharma companies spend more than $5 billion on patient support programs every year, but when it comes to uptake, only 3% of patients are actually using them, according to a new survey from Phreesia Life Sciences...Taking into account people who have ever used any patient support program, the percentage ticks up a bit, but still only gets to 8%. Phreesia, a patient intake platform at point of care, conducted the survey with almost 5,000 people...So why the low usage? Lack of awareness is one clear factor—fewer than one-fourth (23%) of patients said they were extremely or very familiar with patient support programs, while another 18% said they were somewhat familiar...READ MORE
- New law will allow pharmacists to administer HIV prevention medication without prescription (thenevadaindependent.com)
Senate Minority Leader James Settelmeyer
Nevada will become one of the first states to allow pharmacists to prescribe human immunodeficiency virus prevention drugs to patients at risk of contracting the virus, as the state works to combat one of the highest rates of HIV diagnoses in the country...A bill signed by Gov. Steve Sisolak on June 6 authorizes pharmacists with sufficient liability coverage to prescribe, dispense and administer HIV prevention drugs — including post-exposure prophylaxis to people who may have come into contact with HIV and pre-exposure prophylaxis for people at risk — without a prescription from a practitioner starting as early as Oct. 1, in accordance with protocols to be developed by the State Board of Pharmacy over the next several months...READ MORE
- U.K. Supreme Court rejects NHS claim of €220M financial loss in Servier patent lawsuit (fiercepharma.com)
In the culmination of a 10-year case, the U.K. Supreme Court has ruled in favor of Servier Laboratories in its defense against England’s National Health Service over a patent on cardio drug Coversyl...The lawsuit surrounded the French pharmaceutical company’s alleged attempt to block the sale of generic versions of Coversyl by defending a patent that the company knew was not valid. The NHS claimed that Servier caused the government financial loss by deceiving the European Patents Office and the courts and sought €220 million ($300 million) in damages...By a unanimous vote, the court ruled in favor of Servier...READ MORE</strong>
- Biden Order Revisits Trump Answers on Drug Prices, Competition (news.bloomberglaw.com)Executive Order on Promoting Competition in the American Economy (whitehouse.gov)
President Joe Biden
President Joe Biden‘s executive order on competition resurrects Trump administration policy plays geared toward cutting down drug prices, calling for efforts that policy analysts say may face challenges getting off the ground...The executive order signed Friday includes measures to bolster health-care industry competition in the interest of lowering drug prices. Among its proposals are a push for the Food and Drug Administration to work with states to import prescription drugs from Canada and a call for the Federal Trade Commission to crack down on brand drugmakers paying generic manufacturers to delay putting their cheaper products on the market...READ MORE
- Pfizer victory in Vyndaqel copay lawsuit could kneecap the government’s only control on prices, lawyer warns (fiercepharma.com)
After coughing up nearly $24 million in a federal settlement over donations to patient charities, Pfizer went on the offensive last summer and took the U.S.' anti-kickback policies to task. Late last month, the drug giant got its day in court...The company, angling to help Medicare patients pay for its costly heart drugs Vyndaqel and Vyndamax, recently challenged U.S. copay and kickback policies in New York federal court...a Pfizer win...could spur drug pricing fallout across the industry...Pfizer last June sued HHS in a bid to assist patients with their Medicare copays for two costly new medicines. U.S. kickback laws currently forbid drugmakers from helping patients with those costs...Pfizer is battling for the go-ahead on two programs. The first would allow the company to offer copay support directly to Medicare patients on its tafamidis meds Vyndaqel and Vyndamax, which run for $225,000 a year before rebates. The second would allow it to fund an independent charity to help with copays...READ MORE
- How one rural town without a pharmacy is crowdsourcing to get meds (modernhealthcare.com)Association Between Pharmacy Closures and Adherence to Cardiovascular Medications Among Older US Adults (jamanetwork.com)
All Smoked Up BBQ
The building that once housed the last drugstore in this town of fewer than 600 is now a barbecue restaurant, where pit boss Larry Holtman dishes out smoked brisket and pulled pork across the same counter where pharmacists dispensed vital medications more than 30 years ago...It’s an hour long drive over treacherous mountain passes to Laramie, Wyoming, or Granby or Steamboat Springs, Colorado — and the nearest pharmacies. The routes out of the valley in which Walden lies are regularly closed by heavy winter snows, keeping residents in and medications out...Walden has suffered the fate of many small towns across the United States, as the economics of the pharmacy business have made it difficult for community drugstores to survive...With no local access to prescription drugs, the town of mainly cattle ranchers and hay farmers has crowdsourced a delivery system, taking advantage of anyone’s trip to those bigger cities to pick up medications for the rest of the town...READ MORE
- Study: Medicare spent billions more on generics than Costco due to distribution inefficiency (fiercehealthcare.com)
Medicare Part D spent $2.6 billion more in 2018 on generic drugs compared to Costco, likely due to the inefficient distribution system...The study published...in the Journal of the American Medical Association focuses on how intermediaries in the generic drug supply chain may be driving up costs for Medicare. In 2018, 88% of Medicare Part D prescriptions were for generic drugs, the study said...“Our analysis highlighted the inefficiencies the current system introduces through its complex and opaque system of intermediaries, which Costco largely bypasses,”...READ MORE
- Las Vegas hospital hit in cyberattack, data stolen (reviewjournal.com)
University Medical Center acknowledged...that it had experienced a criminal data breach after a notorious hacker group began posting personal information purportedly obtained in the cyberattack...Images of Nevada driver’s licenses, passports and Social Security cards of around half a dozen alleged victims were posted late Monday on the hacker group’s website...The statement said there is no evidence that any clinical systems were accessed in the attack but that patients and employees would be notified that their personal information may be at risk...READ MORE
- Dubbed ‘Baby Doc,’ medical school graduate serves in Nevada Air Guard (reviewjournal.com)
Nevada Air Guard Capt. Caleena Longworth knew at the age of 10 that she wanted to be a doctor, and by January of this year, in the final semester of her medical doctorate program, she was one class away...With the class not set to begin until April, UNLV’s Kirk Kerkorian School of Medicine offered her a two-month vacation. Instead, Longworth, an Air Force veteran and native of Reno, started administering thousands of vaccinations to Nevadans at Cashman Center...READ MORE