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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

Gov. Steve Sisolak declared a state of fiscal emergency on Monday arising from the strain the COVID-19 pandemic has put on public services in the State of Nevada...The global economic fallout of the COVID-19 pandemic is disrupting commerce and negatively impacting revenues across the country, in other states, and in Nevada...Nevada is estimating a significant shortfall of State General Fund revenue with joint estimates from the Governor’s Finance Office and Legislative Counsel Bureau-Fiscal Division ranging from $741 million to $911 million for the fiscal year ending on June 30, 2020...The declaration of a fiscal emergency gives the Governor and the Interim Finance Committee authority to transfer money from the Account to Stabilize the Operation of the State Government – commonly called the Rainy Day Fund – to the general fund...READ MORE

While Gilead has yet to present a marketing plan for the first coronavirus treatment to have shown clinical benefits in a well-designed randomized study, the Institute for Clinical and Economic Review (ICER)—which routinely weighs in on drug costs—says the drug is cost-effective at $4,460 per course of treatment...Even at $1,000 per patient, less than a quarter of ICER's fair price, Gilead could rake in $1 billion in sales this year...The company’s now bolstering supply with the aim to treat 1 million patients by the end of the year...For now, Gilead is donating remdesivir to the U.S. government for allocation, and it's pledged to continue giving doses away until its current supply chain is exhausted...Drugmakers aren’t obligated to follow ICER’s pricing limits, and they often find themselves at odds with each other...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

Congressional leaders are developing the next version of the 21st Century Cures Act, including provisions to advance research related to the COVID-19 crisis as part of initiatives for bringing innovative therapies to market faster. A concept paper for a Cures 2.0 legislative package was recently unveiled by Reps. Diana DeGette (D-Col) and Fred Upton (R-Mich), who sponsored the Cures bill of 2016. It calls for a national COVID-19 testing and response strategy, with specifics for developing and administering vaccines and therapeutics and for modernizing and expanding US biopharma manufacturing capacity to provide needed treatments for patients on a timely basis...READ MORE

It is going to take at least a year for a Covid-19 vaccine to be available; in the meantime, drugs, both novel and repurposed, could provide a quicker alternative for the pharma industry to help resolve the ongoing novel coronavirus pandemic...the pharma industry has focused its efforts on leveraging its disease tackling expertise to find medical solutions to this novel viral disease...“A lot of the focus over the past few weeks has been on vaccines,” noted International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) director-general Thomas Cueni...it is highly unlikely a vaccine will be available for at least 12 to 18 months, drug studies are dominating the short-term response to this public health crisis...there are over 130 treatments in the pipeline for Covid-19 – 77 of which are repurposed and 68 are novel – which is “really good news for all of us”. These range from antimalarials and antivirals to anti-inflammatory drugs and plasma-based treatments...READ MORE

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

As the COVID-19 pandemic started to become more prevalent in Nevada, three medical school students at Touro University Nevada quickly responded to help serve Southern Nevada’s needs...By late March, they launched a website to gather student volunteers to address these needs — from online tutoring, dog walking and even disseminating falsehoods about the virus...“We all as medical students want to help, it’s just in our nature,” said Cassandra McDiarmid, who plans to go into obstetrics and gynecology when she finishes school...“We (Ashlie Bloom, Parisun Shoga) saw there was a need for clinical assistance, but wanted to have something that was not clinical-related such as tutoring and grocery shopping to help out in any way we could,” she said. “We were trying to come up with a way to put all this information in one place and make it easily accessible.”...READ MORE

EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID-19 can be treated...In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or ECMO (extracorporeal membrane oxygenation)...Although remdesivir is not yet authorised for marketing in the European Union, these recommendations for compassionate use will help some patients with severe COVID-19 access the medicine while EMA evaluates data on its benefits and risks. When the evaluation is complete, EMA will make a recommendation on whether or not remdesivir should receive a marketing authorisation...READ MORE