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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

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

Roche scored a major win with the FDA's backing for its COVID-19 antibody tests last week in a field marked by products of questionable quality...Roche will plow $459 million into its manufacturing facility in Penzberg, Germany, to boost production of the antibody test that won an emergency use authorization from the FDA last week...Roche CEO Severin Schwan blasted the current state of COVID-19 serology tests, calling many of the diagnostics "amateur."...“These tests are not worth anything, or have very little use,”...READ MORE

Officials with the FDA have issued an emergency use authorization for remdesivir for the treatment of suspected or laboratory-confirmed coronavirus disease 2019 in hospitalized adults and children, according to a press release...The EUA allows for remdesivir to be distributed in the United States and administered intravenously by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19...Evaluation of EUA criteria and scientific evidence indicate that remdesivir may be effective in treating the virus, for which there are currently no FDA-approved therapies. According to the FDA, “given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.”...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

India, one of the largest drug exporters in the world, has been hit hard by the novel coronavirus pandemic as global lockdowns have complicated daily operations. On one measure—the FDA's nearly two-month ban on foreign inspections—Indian drugmakers are pushing back. And they may have come up with a novel solution...Major Indian pharmaceutical companies are asking the FDA to conduct "desk reviews" or virtual facility inspections during the pandemic in order to "ensure the continuous supply of much-needed drugs in the United States," according to a letter from the Indian Pharmaceutical Alliance...The group also requested the FDA consider recognizing inspections by foreign regulators and temporarily waiving on-site inspections "based on past inspection history and the critical nature of products, such as drug shortages or products that do not currently have generic alternatives."...READ MORE

The United States on Monday began requiring antibody tests for the new coronavirus to undergo a regulatory agency review, acknowledging that its earlier policy had opened the door to fraud...The U.S. Food and Drug Administration had previously required only that companies attest their product was valid and labeled as unapproved, attracting 170 companies to the antibody test market including unscrupulous vendors making false claims...When the FDA put the policy in place on March 16th, it had been under pressure to move fast following a slow ramp up of COVID-19 diagnostic tests that hindered public health efforts...“Flexibility never meant we would allow fraud. We unfortunately see unscrupulous actors marketing fraudulent test kits and using the pandemic as an opportunity to take advantage of Americans’ anxiety,” the FDA said in a statement...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

Doctors on the front lines of the COVID-19 fight really are heroes, but don’t forget about the tens of thousands of 'backline doctors' who are equally at risk, physically and financially...President Trump has compared the fight against COVID-19 to a war against a silent enemy. The soldiers on the front lines are the doctors, nurses, technicians, and others who are fighting it in hospitals across the United States...The untold story, however, is of the hundreds of thousands of doctors facing not only the health risks of caring for patients with undiagnosed COVID-19, but also ruinous financial calamity and professional catastrophe, self-inflicted by government...Now our health-care system is poised to implode...Many patients need care, and not just those with COVID-19. To ensure our system can recover, federal and state governments should implement a few basic provisions.

1. ...the federal government should indemnify doctors against frivolous lawsuits that result from this pandemic.
2. ...the federal government should make available interest-free loans to doctors who feel they cannot reopen offices because of financial hardship inflicted by COVID-19-related mandates. This is important to prevent wholesale migration of small practices to hospitals.
3. ...the federal government should seize this once-in-a-century opportunity to decimate the bureaucracy impeding innovation in medicine. Cutting red tape will stimulate a wave of doctor-led creativity, which is now constrained by onerous laws, such as Stark laws, which restrict collaboration.
4. ...the reprieves that have allowed telemedicine to expand during this pandemic should be made permanent. Doctors need to continue to be paid for these services just as they would for office visits, and be allowed to deliver these services across state lines.
5. ...the playing field in health care needs to be leveled, giving more control to doctors and less to hospitals. State lawmakers should repeal certificate-of-need laws, which prevent competition and the opening of new facilities in certain areas. We were underprepared for this pandemic in part because of hospital consolidation. More resources, not fewer, would provide helpful redundancy and protection against the next pandemic...READ MORE

The Nevada Hospital Association has reportedly threatened to stop providing state health officials with daily reports detailing acute-care hospitals’ coronavirus activity, if those officials share the information with the public...For almost four weeks, the Review-Journal has sought copies of the documents from state and local governments under Nevada’s Public Records Act in order to provide the information to the public. The NHA has refused to provide the reports, which are provided to Gov. Steve Sisolak and other top state officials as they make critical decisions during the COVID-19 outbreak...While the hospital association is a private nonprofit that is not bound to respond to record requests, (Patrick) File (Nevada Open Government Coalition president) said the daily reports became subject to the state’s public records act as soon as the government received copies...READ MORE