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In addressing a mountain of price-fixing claims in the United States, Teva has shown a preference for dealing with charges on a state-by-state basis...Teva agreed to settle with Georgia for $3.346 million, the company checked a third state off its price-fixing litigation list and then crowed about the success of its strategy...The agreement comes on top of settling price-fixing claims with Mississippi last year for $925,000 and with Louisiana five months ago for $1.45 million...The figures are relatively modest compared to the $420 million Teva agreed to pay investors earlier this year who alleged that the company concealed a price-fixing scheme which allowed it to raise the cost of some of its drugs by more than 1,000%...The allegations came to light three years ago when 43 states sued 20 generic drugmakers for divvying up markets and raising prices on more than 100 drugs...READ MORE

...the FDA unveiled a framework to help manufacturers forge risk management plans aimed at combating drug shortages, two trade group heavyweights are sounding their discontent...the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization lobbed comments at the FDA’s draft guidance, issuing similar rebukes as those made by outfits like Civica and the Biosimilars Forum...While PhRMA said it “appreciates” the FDA’s differentiated approach to supply chain risks for varied drug products, plus the risk factors the agency has outlined,” the trade group “believes the draft guidance would benefit from a number of changes to enhance clarity for stakeholders developing and implementing [risk management plans] to mitigate drug shortages.”...BIO, meanwhile, took umbrage with certain terminology used in the FDA’s guidance alongside timing and structures for communication...READ MORE

A local pharmacy will have another chance to earn approval to sell cannabis to adults on its premises, despite the pharmacy’s proximity to a school, when the Las Cruces City Council takes on the issue at an upcoming meeting...At its Sept. 6 meeting, the council will hear an appeal from Mesilla Valley Pharmacy regarding the city Planning and Zoning Commission’s decision in April to deny the pharmacy's request to sell cannabis products. The council could vote on Tuesday to reverse that decision...READ MORE

Bayer AG agreed to pay $40 million to resolve US lawsuits linked to allegations that company officials bribed hospitals and physicians to use its drugs...The settlement stems from two “whistle-blower” suits filed by ex-marketing employee Laurie Simpson almost two decades ago and subsequent litigation by the US government, the US Justice Department said...in a statement. Simpson will receive about $11 million from the settlement, the department said...READ MORE

A new report finds that 1,216 pharmaceuticals increased their prices past the inflation rate of 8.5% from July 2021 to July 2022, with an average hike of 31.6%...The report and a second report on price trends released...by the Department of Health and Human Services underline how a new provision in the Inflation Reduction Act—an inflationary cap on Part D costs—will affect prices right as the cap is implemented Oct. 1...READ MORE

A mother and her daughter have been indicted on health care fraud charges after they allegedly received millions in false Medicare claims...Mirosis Gonzalez...and her daughter Berioska Sosa...used the pharmacy they owned and operated, Aviva Care Pharmacy, to submit over $12 million in false Medicare claims...received payments totaling about $8.4 million...The marketing and telemedicine companies recruited patients and referred Medicare beneficiaries and doctors’ orders and prescriptions to Aviva Care Pharmacy and were paid kickbacks and bribes in return...the companies sent Aviva orders, which the pharmacy accepted...“without considering medical necessity or Medicare reimbursement eligibility.”...They are accused of disguising the kickbacks and bribes they paid to these companies by saying the payments were for marketing and other services...READ MORE</strong>

In another opioid-related settlement for Johnson & Johnson, the company has agreed to pay tens of millions of dollars to settle litigation in New Hampshire...The state sued the company back in 2018, alleging that J&J's subsidiaries “aggressively marketed” opioid painkillers and falsely hawked them as safer than alternatives. Now, just before a trial was set to begin next week, J&J agreed to pay the state $40.5 million...READ MORE

When Food and Drug Administration enacted the Drug Supply Chain Security Act in 2013, it set a 10-year timeline for full implementation. Well, believe it or not, we are just a little more than a year away from that November 2023 deadline...A significant portion of this last milestone requires the entire supply chain to become interoperable using secure and electronic means. One requirement that is included in Title II of the Act calls for product tracing at the package level, which had not been explored widely by the industry until recently. Our DSCSA State Regulator Pilot project tested a system for sharing this information between regulators and trading partners, including distributors, manufacturers, and others...READ MORE

The Alabama Attorney General’s office is investigating the Alabama Pharmacy Board after it revoked the license of a north Alabama pharmacist for working without permission after a felony conviction...Attorney General Steve Marshall’s office dismissed the board’s case against pharmacist Billy Flint East, whose license was taken in March...“Credible allegations have been made about the handling of this matter by employees of the State Board of Pharmacy, which are now under investigation by the Attorney General’s Office,” said the state order...Marshall’s office similarly dismissed the board’s case against East’s current employer, Brooklere Pharmacy, after the Pharmacy Board alleged it did not seek legal approval for East to practice after his conviction...READ MORE

Despite fentanyl being among the leading causes of overdose deaths, few patients are screened for the substance in emergency rooms, a new study finds...The group looked to see how often toxicology screenings, which can inform treatment and public health data, were performed and what substances are tested for. Routine toxicology screens typically test for cocaine, amphetamines, marijuana, phencyclidine and natural opiates like heroin or morphine. Synthetic opioids like fentanyl require a separate test...Three-quarters of all drug overdose deaths in 2020 involved opioids, and the vast majority of those were synthetic...despite a slight rise in fentanyl testing over the years, only 5% of visits are currently tested—the highest testing rate since 2017. Of those screened, more than 40% are positive...READ MORE