- U.S. appeals court upholds Trump health care price disclosure rule (reuters.com)CMS Pricing Transparency Rule Looms: Is Your Hospital Ready? (pharmacypracticenews.com)
A federal appeals court...upheld a White House-backed rule to require hospitals to disclose the prices they negotiate with insurers for an array of common tests and procedures...The...decision...is a victory for President Donald Trump’s effort to make health care pricing more transparent so patients can be better informed when deciding on treatment...The American Hospital Association and other hospital groups had challenged the rule...They said it would require them to divert scarce resources, including to fight COVID-19, to the “herculean” and costly task of compiling health care costs, while reducing competition and causing confusion about patients’ out-of-pocket expenses...READ MORE
- US pays another $2B to buy more doses of Pfizer, BioNTech coronavirus vaccine (biopharmadive.com)
The U.S. government has reached a deal to acquire 100 million more doses of Pfizer and BioNTech's coronavirus vaccine, giving the U.S. enough of a stockpile to vaccinate 100 million total residents. The vaccine is administered via two shots...Under the deal, Pfizer will deliver 70 million doses by the end of June and another 30 million by July 31 The U.S. also retains an option to acquire an additional 400 million doses of the vaccine. As with the original supply deal the two struck in July, Pfizer will receive $1.95 billion, suggesting a per-dose price of about $20...READ MORE
- U.S. Sues Walmart, Alleging Role in Fueling Opioid Crisis (msn.com)
The Trump administration sued Walmart Inc. Tuesday, accusing the retail giant of helping to fuel the nation’s opioid crisis by inadequately screening for questionable prescriptions despite repeated warnings from its own pharmacists...The Justice Department’s lawsuit claims that Walmart sought to boost profits, understaffed its pharmacies and pressured employees to fill prescriptions quickly. That made it difficult for pharmacists to reject invalid prescriptions, enabling widespread drug abuse nationwide, the suit alleges...Walmart, the country’s largest retailer by revenue, has been expecting this complaint and sued the federal government in October to fight the allegations pre-emptively...In its suit, Walmart accuses the Justice Department and Drug Enforcement Administration of attempting to scapegoat the company for what it says are the federal government’s own regulatory and enforcement shortcomings...READ MORE
- The Journalist and the Pharma Bro (elle.com)
Why did Christie Smythe upend her life and stability for Martin Shkreli, one of the least-liked men in the world?...she chucked it all...Over the course of nine months, beginning in July 2018, Smythe quit her job, moved out of the apartment, and divorced her husband. What could cause the sensible Smythe to turn her life upside down? She fell in love with a defendant whose case she not only covered, but broke the news of his arrest. It was a scoop that ignited the Internet, because her love interest, now life partner, is not just any defendant, but Martin Shkreli: the so-called “Pharma Bro” and online provocateur, who increased the price of a lifesaving drug by 5,000 percent overnight and made headlines for buying a one-off Wu-Tang Clan album for a reported $2 million. Shkreli, convicted of fraud in 2017, is now serving seven years in prison...READ MORE
- Trump administration finalizes policy on ‘value-based’ drug deals (biopharmadive.com)
The Trump administration...finalized a rule meant to make it easier for state Medicaid programs, commercial insurers and drugmakers to enter into "value-based" arrangements tying prescription drug payments to clinical outcomes... The rule overhauls existing regulations...Under these types of deals, payers negotiate prices with drugmakers based on outcomes and evidence-based measures like reduced hospitalizations or lab visits, and aren't accountable for the full price if those measures aren't met...CMS estimates that value-based drug deals emerging in the wake of the final rule could save federal and state governments up to $228 million through 2025...READ MORE
- AHA seeks to delay enforcement of Trump admin’s price transparency rule (fiercehealthcare.com)
The American Hospital Association is seeking an emergency stay to delay enforcement of the Trump administration's price transparency when it goes into effect Jan. 1...The AHA and other appellants argue in the filing that the rule should be put on hold until their legal challenge plays out. Hospitals are awaiting a decision from a federal appeals court on the regulation following oral arguments in October...The rule would require hospitals to post payer-negotiated payment rates for 300 shoppable services online beginning Jan. 1. The goal is to encourage patients to shop around for care...READ MORE
- US close on deal with Pfizer for millions more vaccine doses (msn.com)
The U.S. government is close to a deal to acquire tens of millions of additional doses of Pfizer's vaccine in exchange for helping the pharmaceutical giant gain better access to manufacturing supplies...the deal is under discussion and could be finalized shortly...READ MORE
- Only thing more shameful than Purdue’s misleading opioid marketing: Sacklers’ refusal to accept blame (mmm-online.com)
More than a decade ago, Purdue Pharma pleaded guilty to marketing the powerful painkiller OxyContin in a way that illegally downplayed its addictiveness and abuse potential. This past October, the company again admitted criminal wrongdoing for misleading doctors, regulators and the public regarding the drug’s dangers...Last Thursday’s congressional opioid hearing was the first time in years that the family behind Purdue, the Sacklers, would have a chance to take responsibility for it all. But instead of accepting blame for that reckless promotion, two of the family members, who appeared voluntarily under penalty of subpoena, did little more than murmur words of regret for the harmful commercial tactics that made their company’s lead product the poster child for the opioid crisis...While both apologized, neither acknowledged personal (or familial) fault or error...READ MORE
- Scientists Eye Potential Culprit Behind Covid-19 Vaccine Allergic Reactions (wsj.com)Scientists suspect compound in allergic reactions to Pfizer vaccine (axios.com)
Scientists are eyeing a potential culprit causing the allergic reactions to the Pfizer Inc. and BioNTech SE Covid-19 vaccine: the compound polyethylene glycol, also known as PEG...Six severe allergic reactions to the vaccine have been reported in the U.S., according to the Centers for Disease Control and Prevention, out of 272,001 doses administered through Dec. 19. At least two cases of anaphylaxis have also occurred in the U.K. People in the U.S. began receiving Moderna Inc.’s vaccine Monday, and no allergic reactions to it have been reported so far...READ MORE (full story behind pay wall)
- EMA authorizes Pfizer/Biontech vaccine as new SARS-CoV-2 variant emerges (bioworld.com)Comirnaty (BNT162b2) Vaccine (precisionvaccinations.com)
The EMA has issued a positive opinion on Pfizer Inc./Biontech SE’s COVID-19 vaccine, BNT-162b2, becoming the first regulator to recommend a full marketing authorization, rather than approval for emergency use...The vaccine, now brand named Comirnaty, still has to go through the formality of being approved by EU member state governments, but the EU health commissioner, Stella Kyriakides, has said she expects roll out to start on Dec. 27...“This is the first marketing authorization of a COVID-19 vaccine in the EU. It is valid in all 27 member states at the same time,” said EMA Executive Director Emer Cooke. “There is a firm scientific foundation for roll out,” she said...READ MORE