Category:

A top federal watchdog believes the Department of Health and Human Services needs to totally transform how it handles public health emergencies...The Government Accountability Office issued a scathing report...placing HHS on its “high risk” list reserved for government agencies that need transformation or are vulnerable to fraud or mismanagement. The watchdog flagged HHS for several deficiencies that include failing to establish clear roles and responsibilities across its vast purview and providing clear communications to the public...READ MORE

Two physicians enlisted to oversee what would be Nevada’s first execution since 2006 don’t ever want to be identified publicly, state officials told a federal judge...Prison officials want to use a never-before-tried combination of three or four drugs to execute Zane Michael Floyd by lethal injection, including the powerful synthetic opioid fentanyl and the anesthetic ketamine...The 46-year-old Floyd, who was was convicted in 2000 of killing four people and wounding a fifth in a 1999 shotgun attack at a Las Vegas grocery store, does not want to die and has several cases that could delay or stop his execution pending in court...His attorneys have asked U.S. District Judge Richard Boulware II to require the state to provide information about the professional qualifications of any doctors, emergency medical technicians and intravenous injection administrators involved in the execution...READ MORE

Florida has been forced to shut down sites administering monoclonal antibodies, which have been widely used as supplemental treatment for Covid-19, after the FDA revoked authorization for distribution...“This evening, without any advanced notice, the U.S. Food and Drug Administration revised the Emergency Use Authorization for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States,” a press release from the Florida Department of Health read...“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” it continued...READ MORE

Elizabeth Holmes, the Theranos founder convicted of four counts of felony criminal fraud by a jury earlier this month, probably will not receive her sentence until after Labor Day...The filing describes the reason for the delay as related to “ongoing proceedings in a related matter.” The federal fraud trial of Holmes’ co-accused, former Theranos chief operating officer Sunny Balwani, is expected to start in March...She is free on a $500,000 bond secured by her signature, but the filing said her lawyers have agreed with the prosecution to have the bond secured by property...READ MORE

Texas federal judge Mark Pittman will conduct a hearing...to consider whether to allow Pfizer to participate in the redaction and release of information about the development of its COVID-19 vaccine, Comirnaty...Earlier this month, Pittman ruled that the FDA would have to turn over 55,000 pages of documentation on the vaccine per month, starting on March 1...Last Friday, Pfizer provided the court a memorandum outlining why it should participate in the process...“Pfizer supports the public disclosure of the vast majority of this information to promote transparency and the public’s confidence in the vaccine,” the company wrote in the filing. “Pfizer seeks to intervene for the limited purpose of ensuring that information that is exempt from disclosure under FOIA is not disclosed inappropriately.”...READ MORE

A new 'linkage center' aimed at connecting homeless street addicts with drug rehab facilities opened in San Francisco last week - but distressing images show an open air illicit drug consumption site that is now littered with needles and crowded with addicts shooting up in broad daylight...READ MORE

The National Community Pharmacists Association and the American Pharmacists Association... issued the following statement in response to a decision by the U.S. District Court for the District of Columbia to grant a stay the case, NCPA v. Becerra, which challenges the legality of retroactive pharmacy price concessions, also known as pharmacy direct and indirect remuneration fees:...“We are pleased by the court’s decision to grant our request for a stay, or a pause in the litigation, until the recently proposed rule potentially addressing retroactive pharmacy DIR fees is finalized. We are currently analyzing the proposed rule to determine whether it addresses our longstanding concerns with retroactive pharmacy DIR fees, and we plan to submit comments reflecting our analysis. Since our litigation also seeks to end retroactive pharmacy DIR fees, we believe, and the court agreed, that a pause in the case is appropriate pending the outcome of the rulemaking process.”

The lion’s share of California cities and counties have signed off on a national settlement with four major pharmaceutical players to resolve allegations that they fueled the opioid crisis, Attorney General Rob Bonta announced...and that deal will award roughly $2.34 billion to state and local governments...The multistate lawsuit alleged that Cardinal, McKesson and AmerisourceBergen -- all major drug distributors -- had not met their legal duty to refuse to ship opioids to pharmacies that submitted suspicious drug orders. Johnson & Johnson misled patients and doctors about the addictive nature of opioids, the state’s alleged...READ MORE

Electronic Prescribing Mandate for Controlled SubstancesNevada Revised Statutes (NRS) 639.23535 requires that all controlled substance (CS) prescriptions must be transmitted to a pharmacy by electronic prescribing (e-prescribing). While NRS 639.23535 took effect on January 1, 2021, the Nevada State Board of Pharmacy provided an exemption for practitioners by regulation.The law mandated that this exemption would expire on December 31, 2021...READ MORE

Millions of Britons in England may soon be charged for their medication, as the Government plans to raise the qualifying age for free NHS prescriptions to 66, in line with the state pension age. But what does this mean for others entitled to free prescriptions? And can you get free prescriptions if you receive Universal Credit?...Most treatments on the NHS are free, but notable exceptions include paying for prescriptions...Most Britons have to pay for their prescriptions, but there are exceptions including those for people of certain ages, people receiving benefits and pregnant women...Anyone aged under 16, between 16 and 18 but in full-time education, or over 60 is automatically eligible for free prescriptions...For older people, the Government is planning to raise the qualifying age for free prescription from 60 to 66, which could come into force as early as April 2022...READ MORE