Category:

The chief scientist brought on to lead the Trump administration’s vaccine efforts has spent the last several days trying to disentangle pieces of his stock portfolio and his intricate ties to big pharmaceutical interests, as critics point to the potential for significant conflicts of interest...Moncef Slaoui, is a venture capitalist and a former longtime executive at GlaxoSmithKline. Most recently, he sat on the board of Moderna...He resigned when President Trump named him last Thursday to the new post as chief adviser for Operation Warp Speed, the federal drive for coronavirus vaccines and treatments...In agreeing to accept the position, Dr. Slaoui did not come on board as a government employee. Instead, he is on a contract, receiving $1 for his service. That leaves him exempt from federal disclosure rules that would require him to list his outside positions, stock holdings and other potential conflicts. And the contract position is not subject to the same conflict-of-interest laws and regulations that executive branch employees must follow...READ MORE

Rapid coronavirus disease 2 (COVID-19) testing, contract tracing, and preparing for vaccines and treatments are the 3 key priorities as the United States reopens, NACDS said in a new report...Pharmacies: A Vital Partner in Reopening America...The organization also urged that additional steps should be taken to ensure that pharmacists and pharmacies are fully utilized to support this national effort...READ MORE

On Tuesday, May 12, Governor Gavin Newsom granted California’s 47,000 pharmacists the ability to order and administer coronavirus disease 2019 (COVID-19) tests throughout the state. His current objective is to test 60,000 California residents per day. After receiving a request for this expanded authority for pharmacists from the California Pharmacists Association, Newsom recognized that granting pharmacists the ability to test in the state would make that objective possible...READ MORE

The head of the Food and Drug Administration said Friday his agency has provided new guidance to the White House after data suggested that a rapid COVID-19 test used by President Donald Trump and others every day may provide inaccuracies and false negatives...Commissioner Steve Hahn said that if a person is suspected of having the disease caused by the coronavirus, “it might be worth, if the test is negative, getting a second confirmatory test. That’s what our guidance is about.”...The test, by Abbott Laboratories, is used daily at the White House to test Trump and key members of his staff, including the coronavirus task force. The FDA said late Thursday it was investigating preliminary data suggesting the 15-minute test can miss COVID-19 cases, falsely clearing infected patients...READ MORE

U.S. President Donald Trump’s administration awarded a contract worth up to $812 million for a new U.S. company to manufacture drugs and drug ingredients to fight COVID-19 on American soil, aiming to end dependence on other countries...The administration has been looking to build up the ability to produce drugs and their raw materials in the United States after the global pandemic exposed the industry’s dependence on China and India for its supply chain...The U.S Department of Health and Human Services said it had awarded a four-year, $354 million contract to privately-held Phlow Corp to make COVID-19 drugs, other essential drugs and their ingredients. The contract - which is for generic drugs, not more complicated products like vaccines - can be extended to a total of $812 million over 10 years...READ MORE

Federal prosecutors turned up the heat in recent months on a generic price-fixing probe that targeted some of the industry's biggest players before COVID-19 slowed the hunt. Teva, the biggest target in that investigation, has reportedly bailed on settlement talks in a decision meant to test the government's resolve...Teva walked away from negotiations with federal prosecutors, daring the U.S. Department of Justice to pursue criminal price-fixing charges against the drugmaker at a time when it's part of the COVID-19 pandemic response...Teva is betting that its role in aiding the U.S. coronavirus response, including donating millions of doses of antimalarial hydroxychloroquine sulfate to hospitals, will put the Justice Department in a bind on its decision to file charges...READ MORE

Despite the unprecedented impact of coronavirus disease 2019 (COVID-19) on the economy and society, its impact on the health plan enterprise appears to be practical and functional rather than strategic and financial. This conclusion comes from a pilot study with health plan decision-makers...“business as usual."...READ MORE

Work Process
Implications for Manufacturers
Expenditures
Pharmacy
Other Key Business Factor Developments
Maintain Commercial Membership
Shift to Medicaid and Affordable Care Act Markets
New Product Launches

Moderna announced new interim clinical data results for its coronavirus disease 2019 (COVID-19) vaccine candidate from a phase 1 study...The investigational vaccine, called mRNA-1273, was launched...on March 16, making it the first trial to be started in humans for a vaccine for this virus...Tal Zaks, MD, PhD, chief medical officer at Moderna, said in a statement. “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”...Moderna expects to begin its phase 3 study in July 2020...READ MORE

The Texas State Board of Pharmacy issued a new rule that no prescriptions for hydroxychloroquine could be dispensed without a diagnosis, then changed their tune...On March 20...issued a new rule that no prescriptions for hydroxychloroquine or azithromycin could be dispensed without a diagnosis “consistent with evidence for its use.”...Over six weeks after the original rule was published, the Texas State Board of Pharmacy has recently changed its guidance to pharmacists...The website now says, “The rule does not prevent a physician from prescribing one of these drugs for an off-label use. Please note, the intended use for the drug is not required if the practitioner determines the furnishing of this information is not in the best interest of the patient…”READ MORE

The FDA abruptly shut down its on-site facility inspections in March, hoping to keep its employees safe during the novel coronavirus pandemic. More than two months into that moratorium, drugmakers are calling for relief—and with some new guidance, the FDA shows it might be willing to accommodate...The agency is working with the U.S. Centers for Disease Control and Prevention to develop a "phased approach" to restarting inspections of domestic and foreign drug manufacturing facilities, the administration said...the plan would likely continue the agency's focus on high-priority inspections taken on a "case-by-case" basis...READ MORE