- Biden Order Revisits Trump Answers on Drug Prices, Competition (news.bloomberglaw.com)Executive Order on Promoting Competition in the American Economy (whitehouse.gov)
President Joe Biden‘s executive order on competition resurrects Trump administration policy plays geared toward cutting down drug prices, calling for efforts that policy analysts say may face challenges getting off the ground...The executive order signed Friday includes measures to bolster health-care industry competition in the interest of lowering drug prices. Among its proposals are a push for the Food and Drug Administration to work with states to import prescription drugs from Canada and a call for the Federal Trade Commission to crack down on brand drugmakers paying generic manufacturers to delay putting their cheaper products on the market...READ MORE
- New law will allow pharmacists to administer HIV prevention medication without prescription (thenevadaindependent.com)
Nevada will become one of the first states to allow pharmacists to prescribe human immunodeficiency virus prevention drugs to patients at risk of contracting the virus, as the state works to combat one of the highest rates of HIV diagnoses in the country...A bill signed by Gov. Steve Sisolak on June 6 authorizes pharmacists with sufficient liability coverage to prescribe, dispense and administer HIV prevention drugs — including post-exposure prophylaxis to people who may have come into contact with HIV and pre-exposure prophylaxis for people at risk — without a prescription from a practitioner starting as early as Oct. 1, in accordance with protocols to be developed by the State Board of Pharmacy over the next several months...READ MORE
- Supreme Court agrees to hear hospital lawsuit challenging HHS’ 340B cuts (fiercehealthcare.com)
The Supreme Court agreed to hear a major dispute between the hospital industry and the federal government over cuts to 340B hospitals...The court agreed to hear the case during its next term that begins in October...A decision could be rendered sometime next year...The case called American Hospital Association v. Becerra centers on the Medicare reimbursement rate paid for outpatient drugs and whether the Department of Health and Human Services singled out 340B-covered entities...READ MORE
- Viatris scores a win in long-running EpiPen antitrust lawsuit, but patent settlement charge heads to trial (fiercepharma.com)
Generic giant Mylan has faced a slew of lawsuits targeting its EpiPen marketing strategies. Now known as Viatris, the drugmaker says it's scored a win against serious charges in an antitrust case that's been running for several years...The case dates back to 2017 when the plaintiffs...charged Mylan with a number of anticompetitive strategies to build and maintain its EpiPen empire...Mylan also paid excessive rebates to pharmacy benefit managers, commercial payers and state Medicaid programs as long as they didn't reimburse competing products, plaintiffs said. They further cited the well-known and dramatic price hikes Mylan implemented over the years...READ MORE
- Study: Medicare spent billions more on generics than Costco due to distribution inefficiency (fiercehealthcare.com)
Medicare Part D spent $2.6 billion more in 2018 on generic drugs compared to Costco, likely due to the inefficient distribution system...The study published...in the Journal of the American Medical Association focuses on how intermediaries in the generic drug supply chain may be driving up costs for Medicare. In 2018, 88% of Medicare Part D prescriptions were for generic drugs, the study said...“Our analysis highlighted the inefficiencies the current system introduces through its complex and opaque system of intermediaries, which Costco largely bypasses,”...READ MORE
- U.K. Supreme Court rejects NHS claim of €220M financial loss in Servier patent lawsuit (fiercepharma.com)
In the culmination of a 10-year case, the U.K. Supreme Court has ruled in favor of Servier Laboratories in its defense against England’s National Health Service over a patent on cardio drug Coversyl...The lawsuit surrounded the French pharmaceutical company’s alleged attempt to block the sale of generic versions of Coversyl by defending a patent that the company knew was not valid. The NHS claimed that Servier caused the government financial loss by deceiving the European Patents Office and the courts and sought €220 million ($300 million) in damages...By a unanimous vote, the court ruled in favor of Servier...READ MORE</strong>
- Pfizer Pauses Global Sales of Smoking-Cessation Drug Chantix Over Possible Carcinogen Contamination (biospace.com)
Pfizer announced it is pausing the distribution of Chantix (varenicline), its drug to help people stop smoking, after identifying increased levels of nitrosamines in the pills. Nitrosamines are potentially cancer-causing agents. The company is also recalling several lots of the drug...In 2020, the U.S. Food and Drug Administration found high levels of NDMA (N-nitrosadimethylamine) in some formulations of the diabetes drug metformin and had also reached out to Pfizer and other companies over NDMA in unacceptably high levels in a variety of drugs. In 2019, Sanofi's heartburn medication Zantac was recalled over NDMA contamination...READ MORE
- Pfizer victory in Vyndaqel copay lawsuit could kneecap the government’s only control on prices, lawyer warns (fiercepharma.com)
After coughing up nearly $24 million in a federal settlement over donations to patient charities, Pfizer went on the offensive last summer and took the U.S.' anti-kickback policies to task. Late last month, the drug giant got its day in court...The company, angling to help Medicare patients pay for its costly heart drugs Vyndaqel and Vyndamax, recently challenged U.S. copay and kickback policies in New York federal court...a Pfizer win...could spur drug pricing fallout across the industry...Pfizer last June sued HHS in a bid to assist patients with their Medicare copays for two costly new medicines. U.S. kickback laws currently forbid drugmakers from helping patients with those costs...Pfizer is battling for the go-ahead on two programs. The first would allow the company to offer copay support directly to Medicare patients on its tafamidis meds Vyndaqel and Vyndamax, which run for $225,000 a year before rebates. The second would allow it to fund an independent charity to help with copays...READ MORE
- Nevada’s execution drugs expiring as legal battle continues (apnews.com)
Nevada prison officials say one of the drugs they originally planned to use this month in the state’s first execution of an inmate in 15 years expires July 31. Another expires six weeks after a new evidentiary hearing a judge now has scheduled in October to decide if or when four-time convicted killer Zane Michael Floyd will receive a lethal injection...But Nevada’s lawyers said in new court filings two other drugs in the four-drug execution protocol they have submitted to the court are available at least through February...And state corrections’ officials told the judge before he ordered a delay in the execution on Monday that they have access to similar drugs that could substitute for the other two closest to expiration...READ MORE
- Teva reaches $925K settlement with Mississippi in price-fixing case—and it hopes other states will follow suit (fiercepharma.com)
After years of facing allegations of price-fixing on a massive scale, Teva Pharmaceuticals has agreed to settle with the state of Mississippi for $925,000. That "modest" sum could be just the tip of the iceberg...The case dates back to 2019 when Mississippi, along with 43 other states, sued 20 generic drugmakers for divvying up markets and setting prices...it seems states are breaking away from the coordinated effort. Teva’s Mississippi settlement, filed in Pennsylvania federal court on Monday, marks the first agreement the Israeli drugmaker has inked as part of the larger price-fixing debacle...READ MORE