Author: Peter

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

Under pressure to expand public access to new medicines, diagnostic tests, and other medical products needed to detect and treat patients struck by COVID-19, FDA has issued more than 100 Emergency Use Authorizations since early February, compared to fewer than 75 during the 10 previous years. While this activity reflects the imperative for fast action by federal agencies and manufacturers to address the pandemic crisis, it also generates questions about the vetting of these requests and how well FDA can follow up with sufficient tracking of the safety and efficacy of these products. And some observers fear that political interference in the process may erode confidence in the scientific basis for FDA regulatory decisions...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

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

In its effort to combat fraudulent medical products that claim to prevent or treat COVID-19, FDA has issued 42 warning letters, as of May 7, 2020, to companies promoting unproven products claiming to prevent, treat, diagnose, or even cure COVID-19...The agency’s Operation Quack Hack has discovered hundreds of fraudulent drugs, testing kits, and personal protective equipment sold online. FDA has sent numerous abuse complaints to domain name registrars and Internet marketplaces, who the agency says have voluntarily removed the identified postings. “We will continue to monitor the online ecosystem for fraudulent products peddled by bad actors seeking to profit from this global pandemic. We encourage anyone aware of suspected fraudulent medical products for COVID-19 to report them to the FDA,” the agency said in a press release...READ MORE