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After a somewhat chaotic initial rollout by the U.S. government, Gilead Sciences is now taking distribution of COVID-19 drug remdesivir into its own hands...Starting Thursday, Gilead will directly sell remdesivir, branded as Veklury, to American hospitals, ending a five-month phase when the U.S. Department of Health and Human services was responsible for allocating it...AmerisourceBergen will remain the sole U.S. distributor through the end of the year...READ MORE

Pharmaceutical Care Management Association president and CEO JC Scott issued the following statement on today’s hearing in the House Committee on Oversight and Reform on pricing practices for prescription drugs: “We appreciate the House Oversight Committee keeping a spotlight on drug manufacturers’ pricing practices. While drug manufacturers are solely responsible for setting and increasing prescription drug prices, pharmacy benefit managers, PBMs, are the only entity reducing prescription drug costs. PBMs keep prescription drug costs and premiums in check by negotiating lower costs with drug makers and pharmacies...We share President Trump’s intention to keep Medicare premiums affordable...PBMs will continue working with policymakers to advance solutions that encourage greater competition to reduce drug costs for every consumer.”...READ MORE

Justice Department officials...announced a global opioid bust of drug traffickers on the darknet, arresting 179 people and seizing $6.5 million in cash...The operation, dubbed “DisrupTor,” was carried out across the United States and Europe and resulted in the seizure of 274 kilograms (604 pounds) of drugs, including fentanyl, oxycodone, hydrocodone, methamphetamine, heroin, ecstasy, MDMA and other drugs containing addictive substances...READ MORE

Enabling tens of millions of Americans to get themselves speedily vaccinated against COVID-19 will be a huge logistics challenge. A new policy brief from the Mercatus Center, a think tank at George Mason University, argues that we could greatly accelerate the process by removing the complex state regulations that prevent pharmacists from administering vaccines...The...report recommends that state regulators relax age restrictions on pharmacist-administered vaccinations; issue statewide standing orders authorizing pharmacists to administer vaccines without requiring a physician-written prescription for each patient; and revise regulations, as Oregon has, to permit pharmacists to administer all of the vaccines recommended by the CDC's Advisory Committee on Immunization Practices. The latter recommendation "prevents lag in vaccine administration due to boards or legislatures having to approve individually named vaccines for pharmacist administration."...READ MORE

Medical specialists have elected to start Remdesivir therapy for President Donald Trump...Trump has completed his first dose of the drug and is resting comfortably...He is not requiring any supplemental oxygen...Later in the day he was also transported to Walter Reed military hospital for a few days' of treatment as a precautionary measure, though officials said he is expected to remain on the job...READ MORE

The Department of Justice charged 345 people across 51 federal districts in the largest healthcare fraud takedown in the agency's history...The DOJ said the charges were in connection with cases responsible for more than $6 billion in losses. Among those charged were more than 100 doctors, nurses and other medical professionals, according to the DOJ...The billions in false claims were submitted to both public and private insurers,...with more than $4.5 billion connected to telemedicine schemes...In addition, $845 million in fraud losses were linked to substance abuse treatment facilities known as "sober homes," and $806 million was connected to other types of healthcare fraud and illegal opioid distribution...READ MORE

The U.S. Food and Drug Administration has announced the launch of the Digital Health Center of Excellence within the Center for Devices and Radiological Health...the center will be an important step in furthering the agency’s goal of advancing digital health technology, including mobile health devices, software as a medical device, wearables used with medical devices, and technology used to study medical products...The FDA aims to continue building and formalizing the coordinating structure and operation of the center as part of an its effort to modernize policies and regulations, as well as providing efficient access to specialized expertise, knowledge, and tools in accelerated access to digital health technology...READ MORE

Time is running out to secure a post-Brexit trade deal or a “bare minimum” agreement on drugs so as to avoid significant delays to supplies to the UK, MPs have been warned...Experts from the drug, chemical, and aerospace industries have underlined the potential problems ahead after the end of the Brexit transition period in December if no trade deals are secured between the UK and the EU before then. Representatives of these industries appeared before the House of Commons Committee on the Future Relationship with the European Union during an evidence session for its inquiry held on 30 September...READ MORE

Pharmacy groups oppose the FDA’s new final rule that legalizes the importation of drugs from Canada. The rule was published late last week...The final rule implements a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions. According to the FDA, the rule allows states, Indian tribes, and – in certain future circumstances – pharmacists and wholesalers, to submit importation program proposals to the agency for review and authorization...the American Pharmacists Association criticized the agency’s rule...the new rule jeopardizes patient safety by creating supply chain vulnerabilities that could potentially introduce counterfeit or unsafe drugs...READ MORE

When President Trump unveiled Operation Warp Speed in May, he declared that it was “unlike anything our country has seen since the Manhattan Project.”...Operation Warp Speed is largely an abstraction in Washington, with little known about who works there other than its top leaders, or how it operates. Even pharmaceutical companies hoping to offer help or partnerships have labored to figure out who to contact...Now, an organizational chart of the $10 billion initiative...reveals the fullest picture yet of Operation Warp Speed: a highly structured organization in which military personnel vastly outnumber civilian scientists...that many of the Warp Speed discussions take place in protected rooms used to discuss classified information...“This is a massive scientific and logistical undertaking,”...“We are weeks away, at most, a month or two away from having at least one safe and effective vaccine.”...READ MORE