- A Video History of Pharmacies and Prescription Prices: From Soda Fountains to GoodRx (drugchannels.net)
...“Why Pharmacies Overcharge,” an entertaining and provocative video on the pharmacy industry and its generic prescription pricing...It’s definitely worth your time...The video covers the history of pharmacy, from the “Soda Fountain Era” to “Lick, Stick, and Pour” to the rise of PBMs and GoodRx...READ MORE
- CMS delays enforcement of key parts of price transparency rule by 6 months (fiercehealthcare.com)
The Biden administration has delayed enforcement of key parts of a major insurer price transparency rule by six months until July 1, 2022, to give plans more time to comply...The Centers for Medicare & Medicaid Services announced the change in a new guidance released Friday focusing on the final price transparency rule released last October under the Trump administration. The guidance focuses on a requirement that certain health plans disclose online their in-network provider rates for covered items and services, out-of-network allowed amounts and billed charges for certain items and services...READ MORE
- Who’s getting the most out of their R&D engine? Pharma’s top 11, ranked (fiercepharma.com)
Drugmakers have myriad tools in their arsenal when looking to grow sales. They can acquire marketed drugs, raise prices or focus on growing the reach of their existing medicines. But it's often new drug approvals that reign supreme and ultimately prove the worth of a company's development engine...covered in a recent Evaluate Vantage report, the team at Fierce Pharma took a close look at the recent approvals for 11 of the world's biggest drugmakers by revenue. Specifically, we're highlighting the dollar value of the industry's launches from the last five years and analyzing how the new meds fit into each company's overall portfolio...READ MORE
- FDA set to issue full approval for Pfizer vaccine on Monday (msn.com)
The New York Times reports that the Pfizer shot will be the first of the coronavirus jabs to be cleared by the FDA...According to the report, the FDA originally had planned to approve the vaccine before Labor Day, but decided to accelerate its ruling...The full approval of the shot also paves the way for employers and private companies to mandate employees and patrons to be vaccinated...READ MORE
- In talc case, reorg ruling goes Johnson & Johnson’s way, keeping bankruptcy in play (fiercepharma.com)
With 25,000 unresolved lawsuits alleging that its talcum products cause cancer, Johnson & Johnson is considering a legal maneuver sometimes referred to as the Texas two-step... a U.S. judge declined to block the move, giving the pharmaceutical giant the option to create a new business to absorb liabilities associated with the litigation and then seek bankruptcy protection...U.S. bankruptcy judge...denied a plaintiffs' request to issue a restraining order against J&J to prevent the company from employing the tactic, first used by firms decades ago to mitigate the costs associated with asbestos claims...READ MORE
- Nevada to pursue separate opioid litigation against major drug companies; new statewide distribution plan adopted (thenevadaindependent.com)
Nevada will not sign on to a proposed $26 billion multistate settlement with the nation’s three largest drug distribution companies and drugmaker Johnson & Johnson — businesses accused of fueling the nation's opioid epidemic that has killed thousands of Nevadans — in hopes of getting a better deal...Attorney General Aaron Ford told The Nevada Independent...that the state would have received roughly $240 million from the settlements — an amount he called “woefully insufficient” — and that the state will instead pursue separate negotiations with the companies “to ensure that the people in this state are adequately recompensed for the damages that opioids have caused in our communities.”...READ MORE
- Pfizer, BioNTech score FDA’s first full COVID-19 vaccine nod, quickly triggering stricter mandates (fiercepharma.com)
The U.S. FDA has awarded the first full approval for a COVID-19 vaccine to Pfizer and its German partner BioNTech, a historic decision that comes weeks ahead of its previously expected Labor Day deadline...Pfizer’s jab, now approved for people aged 16 and older, will remain under an emergency nod for adolescents aged 12 to 15...The agency’s full approval for Pfizer’s mRNA shot, now marketed as Comirnaty, is expected to spark a wave of vaccine mandates from companies, universities and organizations awaiting the agency’s final sign-off...READ MORE
- FDA User Fees to Rise and Fall as New Fee Agreements Move Forward (pharmtech.com)
Biopharmaceutical companies will pay more than $3 million to file an application seeking FDA approval of a new drug application or biologics license application during fiscal year 2022. This record charge to evaluate new drugs and biologics reflects agency analysis of additional personnel and resources needed to process its growing workload. The annual program fee paid by each manufacturer with marketed prescription drugs holds fairly even at about $370,000. And while the actual increase in the application fee is not that much, passing the $3 million mark has drawn attention and further concern about FDA’s overdependence on revenue from regulated industry...READ MORE
- FDA Says “Stop It” to Self-Medicating for COVID-19 with Unapproved Treatments (biospace.com)
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This is the Food and Drug Administration's recently tweeted advice to Americans seeking out alternative, unapproved treatments for COVID-19...The comment is aimed mainly at Mississippi residents as a follow-up to the state’s official Health Network Alert issued Friday. The Magnolia State has experienced increasing calls to its poison control line, with 70% of the calls related to the ingestion of the livestock formulation of anti-parasitic drug ivermectin...While ivermectin is FDA-approved to treat and prevent parasite infections, the drug commonly found at most local feed stores is highly concentrated for large animals such as horses and cows. In that type of formulation, it can be highly toxic to humans...READ MORE
- Most Americans Oppose Biden’s Prescription Drug Price Controls (realclearhealth.com)
In response to U.S. prescription drug spending rapidly outpacing inflation, reaching an estimated $358.7 billion in 2020, President Biden last week demanded that Congress adopt strict federal price controls on prescription drugs...to cap annual out-of-pocket drug spending for Medicare beneficiaries, empowering the Secretary of Health and Human Services to choose pharmaceutical winners and losers, and financially crippling penalties for pharmaceutical companies that don’t acquiesce to price controls — are likely to have disastrous effects on the availability of critical medications. What’s more, they’re deeply unpopular with the overwhelming majority of Americans, and could prove to be a significant fiscal and health liability for our nation in the years to come...READ MORE