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Merck is suing the Biden administration to avoid potential fines for cutting off 340B contract pharmacies from getting discounted products...The pharmaceutical giant argues in a federal lawsuit filed Friday in the U.S. District Court for the District of Columbia that favorable rulings in similar cases make a warning letter from the federal government moot. The lawsuit is the latest in a feud between the federal government and drugmakers over the 340B program...In 2021, Merck became among nearly 20 drugmakers that cut off sales of 340B-discounted drugs to contract pharmacies, which dispense the products on behalf of covered entities. Merck told 340B entities that if they do not join the company’s integrity program and submit claims-level data then it will no longer provide the drugs to contract pharmacies...READ MORE

Apparently, a $107 million deal value isn't large enough to be considered anticompetitive when viewed in the context of delaying generics to a blockbuster brand...A Delaware federal judge reached that conclusion when he threw out an antitrust claim targeting a pay-for-delay deal between AstraZeneca and generic maker Accord Healthcare over the British pharma’s popular antipsychotic Seroquel XR...But that was only a half-win for AstraZeneca in a class action suit. The judge has allowed another similar claim brought by drug wholesalers, retailers and payers against a separate deal that AZ originally signed with Handa Pharma and later passed on to Endo’s Par Pharmaceutical...Both claims allege that the “reverse payment” agreements AZ inked with those generic makers to settle Seroquel XR patent disputes delayed and suppressed competition, causing higher prices...READ MORE

Pharmacies are temporarily limiting purchases of the morning-after contraception pill following a surge in demand prompted by the U.S. Supreme Court’s reversal of Roe v. Wade...CVS, Walmart and Rite Aid...announced purchase limits on emergency contraceptives. Some Michigan pharmacists have reported shortages, but most stores are still stocked and dispensing the pill, said Farah Jalloul, state emergency preparedness coordinator for the Michigan Pharmacists Association...READ MORE

Some 20 million babies, toddlers, and preschoolers are now eligible to be vaccinated for COVID-19, after the Centers for Disease Control and Prevention's Director Dr. Rochelle Walensky signed off on unanimous votes from her agency's outside vaccine advisers to recommend shots from Moderna as well as Pfizer and BioNTech for children as young as six months old..."Together, with science leading the charge, we have taken another important step forward in our nation's fight against COVID-19," Walensky said...READ MORE

America’s economically disadvantaged patients can point in two directions when talking about what is wrong with the 340B Drug Pricing Program, which is designed to help hospitals caring for underserved communities — and the patients they treat — keep necessary medicines reasonably priced: large supposedly “nonprofit” hospitals and for-profit pharmacy benefit managers that serve as 340B contract pharmacies, which together divert billions of dollars in savings that should be helping patients in need...The problem is that the 340B program has become a slush fund for its other participants, the large, supposedly nonprofit hospitals and health systems. They buy drugs at steep 340B discounts, then charge insurers, the uninsured, and cash-paying patients a huge markup. The profits pad the hospitals’ bottom lines and provide ample capital to take over and consolidate local markets, particularly in cancer care. And the result is shockingly little charity care...READ MORE

...the U.S. Food and Drug Administration took the unusual step of authorizing pharmacists to directly prescribe antiviral medication Paxlovid to patients testing positive for COVID-19...But don’t expect to get a prescription right away from your neighborhood pharmacist for the pills...Major pharmacy chains and a state regulatory agency said Friday that they’re continuing to work with the FDA on how to best implement the change, including whether any new costs will be passed on to patients. Although the details still need to be worked out, the change was applauded by the industry...“I’m elated,” said Christina Madison, an associate professor at the College of Pharmacy at Roseman University in Southern Nevada...The change eliminates a barrier to getting treatment, especially in rural areas and “medical deserts” where a pharmacy is “the only place a person can get medical information for miles,” she said...READ MORE

In the wake of Roe v. Wade being overturned, a legal battle over access to abortion-inducing medication is brewing...Medication abortion...is already used in more than half of recent abortions in the U.S., is preferred by many because it’s cheaper, less invasive and offers more privacy than the surgical alternative...The pills can be obtained through the mail and taken at home after a patient meets with a doctor in-person, over video or phone, or by filling out an online form...Those consultations must take place in a state where abortion is permitted, and clinics can use the IP address of the computer or phone a patient uses to identify their location...States angling to ban all forms of abortion may have a difficult time stamping out medication abortion, however, which would be far more complicated than simply shutting down a clinic...READ MORE

Watch out, pharma—the federal government has its eye on add-on drug patents that can lead to higher prices. In a new effort, the FDA and the U.S. Patent and Trademark Office (PTO) are teaming up to take a close look at patenting procedures...the PTO said it plans to crack down on patenting of “incremental, obvious changes to existing drugs that do not qualify" for new protections...The latest effort is the result of officials at the PTO and the FDA exchanging letters outlining their concerns about pharma patents. The joint work is set to expand their resources for patent regulation...READ MORE

California will start making its own affordable insulin as part of an effort to combat high drug prices for a lifesaving medication that's been made inaccessible for some Americans living with diabetes, Democratic Gov. Gavin Newsom announced...Newsom said in a video posted to Twitter that $100 million from the state budget he recently signed for 2022-2023 would be allocated for California to "contract and make [its] own insulin at a cheaper price, close to at cost, and to make it available to all." Half of the $100 million would go toward the development of a "low-cost" insulin, Newsom said. The other $50 million would go toward a facility in the state to manufacture insulin that would "provide new, high-paying jobs and a stronger supply chain for the drug."...READ MORE

The United States government could save billions of healthcare dollars if it purchased generic drugs at the prices offered by Mark Cuban’s new online pharmacy that was launched this year...In a comparison between Medicare’s spending in 2020 and the prices of Cuban’s Cost Plus Drug Company, researchers found that Medicare could have saved $3.6 billion, according to new research from Brigham and Women’s Hospital and Harvard Medical School published...in the journal Annals of Internal Medicine...READ MORE