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The Drug Enforcement Administration has alleged that telehealth and digital pharmacy company Truepill unlawfully dispensed thousands of prescriptions for stimulant medications such as Adderall...The DEA announced last week that it served the startup with an order to show cause, which is an administrative action to determine whether a DEA certificate of registration should be revoked...Between September 2020 and September 2022, Truepill filled more than 72,000 controlled substance prescriptions, 60% of which were for stimulants including generic forms of Adderall, according to the DEA's investigation...READ MORE

With the era of free COVID-19 vaccines winding down in the U.S., lawmakers are pressing Pfizer for a fair Comirnaty price tag and singling out the pharma giant for its “unseemly profiteering.”...Sen. Elizabeth Warren of Massachusetts and Vermont Sen.-elect Peter Welch blasted Pfizer’s purported Comirnaty pricing scheme—which could see the company charge between $110 and $130 per vaccine dose on the private market—as “pure and deadly greed.”...To date, more than 650 million COVID-19 vaccine doses have been administered in the U.S...Warren and Welch explained. But that “public health achievement” is “now at risk” thanks to Pfizer’s greed, they warned...READ MORE

In a development in what’s being billed as one of the largest healthcare fraud schemes ever, a federal grand jury yesterday convicted the owner of a laboratory that performs sophisticated genetic tests of bilking Medicare out of hundreds of millions of dollars...The crime involved telemarketers allegedly lying to Medicare recipients by ensuring them that they were covered for expensive genetic cancer tests...Telemedicine physicians allegedly approved the tests even though they hadn’t treated the patients and, in many cases, hadn’t even spoken to them. The DOJ said dozens of suspects might be involved in the scheme in which $463 million in questionable claims were made to Medicare...READ MORE

To encourage sponsor application for over-the counter naloxone, the US Food and Drug Administration (FDA) today issued a Federal Register notice, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use,” that could help facilitate the development and potential approval of nonprescription naloxone drugs...“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, MD. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”...READ MORE

The former Sparks fire chief accused of illegal possession and distribution of steroids says he never gave his resignation and wants to be reinstated...Mark Lawson’s lawyers said in a letter sent to Sparks officials this week he should be returned to his role and placed on paid administrative leave pending the outcome of his criminal case...They said Lawson maintains his innocence and threatened to file a civil lawsuit alleging he was “condemned, terminated and tried in the public” before criminal charges had been filed. But he is confident the criminal complaint will be dismissed...READ MORE

The care given in emergency departments came under fire yesterday with the release of a government study saying that 250,000 Americans die every year due to misdiagnoses...The findings spurred an immediate response from the president of the American College of Emergency Physicians, who questions the study’s veracity and methodology...Christopher S. Kang, M.D., president of the ACEP, said in a statement that “in addition to making misleading, incomplete and erroneous conclusions from the literature reviewed, the report conveys a tone that inaccurately characterizes and unnecessarily disparages the practice of emergency medicine in the United States.”...The study, conducted by Johns Hopkins for the Agency for Healthcare Research and Quality, states that among 130 million ED visits in the U.S. per year, 7.4 million patients are misdiagnosed. In addition, 2.6 million suffer an adverse event, and about 370,000 suffer serious harm from diagnostic errors...READ MORE

The convicted ex-CEO of blood-testing startup Theranos got a multi-year prison term Friday. Prosecutors had sought a term with deterrent effect...Elizabeth Holmes, who was convicted 10 months ago of defrauding investors in the blood-testing startup Theranos, was sentenced Friday to 11 years and two months in prison followed by three years of supervised release...Judge Edward Davila, who also presided over Holmes’ four-year criminal fraud case and her four-month trial in U.S. District Court in San Jose, said the case was “troubling on so many levels,” as he handed down the sentence...“Failure is normal. But failure by fraud is not OK,”...READ MORE

Four felony drug charges were announced Friday against Mark Lawson after he resigned Monday as Sparks fire chief...The charges include possession of a controlled substance and sale of a controlled substance...A co-defendant listed in the case is Lance Forrester. As recently as 2020, Forrester was employed as a correctional officer with the state, according to Transparent Nevada...Arraignment is set for Jan. 31 in Sparks Justice Court...The charges seemed to take the city of Sparks by surprise. Lawson’s hiring was approved by the Sparks City Council on Nov. 28 with pay of $200,000 plus benefits...READ MORE

The Biden administration is facing mounting pressure from states to let them import medicine from Canada to help lower prescription drug costs...Colorado...became at least the fourth state to seek federal permission to use the strategy, following Florida, New Hampshire, and New Mexico...President Joe Biden has endorsed the approach, but his administration has yet to greenlight a state plan...“States have done the work, and the only thing preventing them from going ahead is the Biden administration,”...Health and Human Services Secretary Xavier Becerra told KHN (Kaiser Health News)...that the Biden administration welcomed applications for drug importation programs from Colorado and other states. But he would not pledge that the FDA would rule on any application in 2023...READ MORE

The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price...Now that the dust has settled over enactment of the Inflation Reduction Act, leaders across the industry should be taking stock and assessing how the law will impact their product portfolios and the bottom line. Although several open questions remain, pharmaceutical manufacturers can take actions to best position their organizations to either benefit from — or mitigate repercussions — of the new law. Specifically, executives should lay out strategies for addressing revenue optimization, evidence development planning and portfolio optimization...READ MORE