Author: Peter

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

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

Telehealth providers and advocates are balking at proposed telemedicine rules released by the Drug Enforcement Administration...If made permanent, the rules would be a marked change from the suspension of the Ryan Haight Online Pharmacy Consumer Protection Act, which propelled a telepsychiatry boom during the COVID-19 pandemic...Under the proposed rule released by the DEA...some medications would require an in-person doctor’s visit. Controlled substances including stimulants like Adderall and opioids such as oxycodone and buprenorphine used to treat opioid use disorder would require at least one in-person visit...READ MORE

The Biden administration rolled out new guidance to drugmakers for meeting a new requirement to dole out rebates if their prices on Medicare Parts B and D go above inflation...The guidance...implements a key part of the Inflation Reduction Act passed last year. Drug companies had to start paying rebates for raising prices past inflation back in January, with the amounts going back to Medicare...“We are fighting to rein in the excessive cost of skyrocketing prescription drug prices, and now drug companies that increase their prices faster than the rate of inflation will have to pay rebates back to the Medicare Trust Fund,” said HHS Secretary Xavier Becerra in a statement...READ MORE

The number of drugs excluded from the three largest pharmacy benefit manager formularies reached an all-time high in 2023, despite concerns that profits are being put ahead of patient access. This year, CVS Caremark, Optum Rx and Express Scripts — which together handle 80% of all prescriptions in the United States — each have roughly 600 medications on their standard formulary exclusion lists...Exclusions leave patients with fewer options for treatment unless they can afford the out-of-pocket costs of buying drugs that are not covered by the insurer. What is even more disturbing are the trends within the trend of formulary exclusions, critics say,,,READ MORE

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

After receiving more than $320 million so far from settlements with opioid companies, the state has created a process to divide it across all Nevada counties...the attorney general’s office debriefed members of the Assembly Committee on Revenue on the One Nevada Agreement on Allocation of Opioid Recoveries...“We included all counties — whether or not they were litigating or non-litigating — so that they all are receiving something because frankly, this opioid epidemic does not care about county lines or city lines,” said Chief Deputy Attorney General Mark Krueger...One of the more recent settlements was $32 million the state received through opioid litigation with Walmart...READ MORE

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 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

KRNV-TV reported...that in response to a public records request, the board said it has 455 pending cases, including three on hold since 2016 because police also are investigating...Medical Board Executive Director Ed Cousineau told KRNV-TV that staffing issues can make it difficult to complete investigations in a timely manner...But Reno attorney Julie Throop said delays of seven years can make it too late for attorneys to use board findings in court...KRNV-TV said records showed 301 pending complaints filed against doctors last year and 140 unresolved since 2019. It found eight outstanding complaints from 2018 and three from 2017...READ MORE