- Emergent makes history with first FDA nod for over-the-counter naloxone (fiercepharma.com)
...the FDA approved the first over-the-counter naloxone product...the U.S.’ drug regulator blessed Emergent’s 4mg Narcan nasal spray with a nonprescription nod, teeing up direct-to-consumer sales at places like drug stores, convenience stores, supermarkets and gas stations...the timeline on which the product will be made available at stores—as well as its price—is up to Emergent...Other formulations and dosages of naloxone will remain prescription only, though there are access laws that technically permit pharmacies across all 50 states to dispense the emergency drug without a doctor’s note...READ MORE
- Las Vegas, Las Vegas Strip Have An Unexpected Cannabis Problem (thestreet.com)Nevada cannabis lounges stoke DUI fears as fatal crashes rise (reviewjournal.com)
When Nevada legalized recreational cannabis, people expected the normal array of problems as Las Vegas tourists over-indulged...Legalized cannabis, however, has come with its own set of unique problems. First and foremost casino operators including the Las Vegas Strip's biggest operators...Since they're regulated by federal law, casino operators can't house dispensaries or Las Vegas's newly-approved cannabis lounges. That means that people not only have to leave their Strip or downtown resort in order to buy marijuana, but they also have to leave to legally smoke it...that quirk in the law keeps tourists from smoking and driving. That could change later this year when new rules allow dispensaries like Planet 13 to add consumption lounges to their locations...READ MORE
- Walgreens won’t sell abortion pills in GOP states after legal threats from state officials (fiercehealthcare.com)
Walgreens will not dispense abortion pills in nearly two dozen states after legal threats from GOP lawmakers, the retail pharmacy chain confirmed...The Walgreens decision stems from a letter written by nearly two dozen Republican state attorneys general at the beginning of February that threatened legal action if the company began distributing mifepristone in their states...Walgreens...spokesperson saying “we are not distributing mifepristone at this time. We intend to be a certified pharmacy and will distribute mifepristone only in those jurisdictions where it is legal and operationally feasible.”...READ MORE
- How a Drug Company Made $114 Billion by Gaming the U.S. Patent System (dnyuz.com)AbbVie’s global bestseller to face knockoffs starting this week (msn.com)
In 2016, a blockbuster drug called Humira was poised to become a lot less valuable...Through its savvy but legal exploitation of the U.S. patent system, Humira’s manufacturer, AbbVie, blocked competitors from entering the market. For the next six years, the drug’s price kept rising. Today, Humira is the most lucrative franchise in pharmaceutical history...Next week, the curtain is expected to come down on a monopoly that has generated $114 billion in revenue for AbbVie just since the end of 2016. The knockoff drug that regulators authorized more than six years ago, Amgen’s Amjevita, will come to market in the United States, and as many as nine more Humira competitors will follow this year from pharmaceutical giants including Pfizer. Prices are likely to tumble...READ MORE
- Bipartisan caucus in US Congress looks to boost domestic drug manufacturing (fiercepharma.com)
...the Domestic Pharmaceutical Manufacturing Caucus for the 118th Congress...will focus on domestic production of finished drugs and active pharmaceutical ingredients...Members of the caucus said they will look to advance legislation that incentivizes more domestic production for essential medicines as part of an effort to reduce U.S. reliance on foreign countries. The lawmakers also aim to head off potential supply chain disruptions and ensure a steady supply of pharmaceuticals in the event of public health emergencies...READ MORE
- Eli Lilly slashed insulin prices. This starts a race to the bottom (fiercehealthcare.com)
When drugmaker Eli Lilly announced...it will slash the list price for some of its insulin products following years of criticism from lawmakers and activists that the price of the lifesaving hormone had become unaffordable, the news raised questions about what will happen to other efforts to provide low-cost insulin...Civica...has said it plans to begin selling biosimilar insulin for roughly $30 per vial by 2024—$5 more than the new price of Eli Lilly’s generic insulin...Mark Cuban said his new company, the Mark Cuban Cost Plus Drug Co., planned to sell low-cost insulin. And California is poised to launch an ambitious program to manufacture its own brand of the hormone, as well as generics of other high-priced prescription drugs...READ MORE
- Sanofi, Pfizer join roster of pharmas marshalling relief for Turkey and Syria after deadly quake (fiercepharma.com)
As rescue efforts continue in the wake of a cataclysmic earthquake on the border of Turkey and Syria, drugmakers near and far are rushing to offer aid...Novartis and its generics arm Sandoz are putting up $1 million for the cause. At present, the companies are working to identify the right partners to “make sure this support gets to those most in need,”...Novartis also said it's in close contact with its local team to ensure the well-being of some 1,600 staffers and their families in the region...Bayer...will donate a total of 1.5 million euros to the affected regions...READ MORE
- As US drug shortages persist, House committee presses FDA for answers (fiercepharma.com)
With drug shortages becoming increasingly common...House Republicans are pressing the FDA for answers. At the heart of the investigation is whether the FDA has done enough to prevent and respond to the current spate of shortfalls, which have affected cancer meds and nonprescription painkillers alike...In a letter...Republican leaders from the House Committee on Energy and Commerce pressed FDA Commissioner...to respond 10 questions on the FDA’s tracking of scarce medicines, its inspection priorities and what the agency has done to parse and prevent shortages...READ MORE
- Teladoc-owned BetterHelp to pay $7.8M to online therapy users for alleged data misuse, per FTC order (fiercehealthcare.com)
The Federal Trade Commission has reached a settlement with online therapy company BetterHelp...over allegations that it shared consumers’ health data with companies like Facebook and Snapchat for advertising purposes...BetterHelp is banned from sharing consumers’ health data, including sensitive information about mental health challenges, with third parties for marketing and ad targeting...BetterHelp also agreed to pay $7.8 million to consumers to settle charges that it revealed consumers’ sensitive data with third parties for advertising after promising to keep such data private...READ MORE
- States Move to Ban Accumulators (drugtopics.com)The State of Employers’ Pharmacy Benefits: A Review of 2022 and the 2023 Outlook for Copay Programs (drugchannels.net)How Copay Accumulators and Maximizers Have Changed Payers’ View of Copay Support (drugchannels.net)
Sixteen states have banned a pharmacy benefit management practice that involves not counting the value of drug copay assistance from manufacturers toward patient deductibles...Drugmakers use copay assistance programs to shield patients from out-of-pocket expenses — and build market share for their products in the process. But pharmacy benefit managers have cried foul, saying the copay programs undercut formularies and wind up increasing the use of expensive drugs that are not any better than less expensive ones. They have pushed back with “copay adjustment programs,” especially “copay accumulators,” which are designed to blunt the effect of the copay assistance programs by not counting their value toward patient deductibles...READ MORE