Coronavirus Roundup: Watchdog Says FDA Needs More Transparency on Therapeutics; USPS Expands ‘Operation Santa’ for Pandemic 

The National Union of Healthcare Workers, which represents 15,000 health care personnel, called on the president to invoke the 1950 Defense Production Act again to address the “severe” need for personal protective equipment as coronavirus cases are soaring. “If President Trump won’t take immediate action to place the production of PPE on a wartime footing, President-elect Joe Biden must ramp up manufacturing of critical supplies as one of his first acts on January 20,” said Sal Rosselli, union president. “Only the federal government has the power and reach to adequately boost production of the necessary supplies.” He also urged the administration to expand access to testing, which has been readily available “for professional athletes and students attending elite universities, but this has not been the story for large numbers of front-line health care workers.” Here are some of the other recent headlines you might have missed. 

The Government Accountability Office said in a report issued on Tuesday that the Food and Drug Administration needs to be more transparent about how it issues emergency use authorizations for coronavirus therapeutics. It “can do this by identifying ways to uniformly disclose information from its scientific review of safety and effectiveness data—similar to the agency’s public disclosure of such data supporting the approval of new drugs and biologics—when it issues an EUA for a therapeutic or vaccine,” said GAO. “FDA officials agreed that more transparency in these decisions is needed, but noted that federal law may restrict the type of information the agency can disclose for [emergency use authorizations] absent the sponsor’s consent … FDA could seek authority to make such information available,” which “could help increase the public’s confidence in FDA’s [emergency use] decisions.” 

The Veterans Affairs Department announced on Monday it’s recruiting veterans and non-veterans to participate in coronavirus clinical trials at over 50 VA medical centers nationwide. “VA is eager to play a role in this important endeavor,” VA Secretary Robert Wilkie said. “Volunteering for our trials is a way people can help our country more quickly find vaccines and treatments to end the pandemic and get life back to normal.”

A new study published last week in the New England Journal of Medicine found that the majority of the sailors who tested positive for COVID-19 on the aircraft carrier U.S.S. Theodore Roosevelt, which suffered a coronavirus outbreak in the spring, were asymptomatic, Federal News Network reported on Monday. While 27% of the approximate 1,300 sailors aboard tested positive at some point, about 77% of those were asymptomatic when they tested positive. Also, about half of them never had any symptoms. 

The U.S. Postal Service is expanding its annual “Operation Santa” this year due to the pandemic. For the first time, the process for those looking to play “Santa” for kids in need is digital and they can help kids anywhere in the country. “2020 has seen its share of challenges affecting individuals and families in so many ways. COVID-19 resulted in job losses, temporary unemployment and, sadly, the loss of family and friends,” Postal Service Spokeswoman Kim Frum told USA TODAY on Monday. “Couple that with devastation from natural disasters, and it’s easy to see why USPS’ Operation Santa program is more important than ever.”

After his speech on the economy on Monday, President-elect Joe Biden told reporters “more people may die if we don’t coordinate” with the Trump administration on the vaccine plans. The General Services Administration has not yet ascertained Biden as the winner, which prevents his team from getting briefed by the agencies, among other things. “A vaccine is important. It’s of little use until you are vaccinated. So how do we get the vaccine, how do we get over 300 million Americans vaccinated? What is the game plan? It is a huge, huge, huge undertaking to get it done,” Biden said. “If we have to wait until Jan. 20 to start that planning, it puts us behind over a month, month and a half. And so, it’s important that it be done, that there be coordination now. Now or as rapidly as we can get that done.”

In lieu of being able to meet with the agencies on the coronavirus vaccine progress, Biden’s advisers are planning to meet with the vaccine manufacturers soon, The Associated Press reported on Monday. Read more from Government Executive here about how the Biden team is moving forward on the transition without formal recognition from the Trump administration. 

The Federal Election Commission inspector general said in a report on the FEC’s management challenges for fiscal 2021, published on Monday, that the pandemic poses an ongoing challenge to the agency’s operations “due to the volatility of the situation.” However, it identified the ways the FEC has adapted to the situation, such as by establishing flexible work schedules for staff and encouraging complainants to use electronic signatures and notarizations when allowed by state law. 

On Tuesday, the Justice Department IG published its findings on remote inspections of two Federal Bureau of Prisons correctional complexes in Louisiana, which “experienced disparate outcomes regarding COVID-19 transmission,” despite only being 53 miles apart. “Although we cannot fully identify all of the reasons why Oakdale experienced a significant early COVID-19 outbreak and Pollock did not, we noted that Oakdale experienced a large-scale spread of COVID-19 within its low security federal correctional institution and minimum security satellite camp, facilities with open layouts in which it is inherently difficult to socially distance inmates,” said the IG. “Conversely, at FCC Pollock, which did not experience as significant an outbreak, other than the approximately 100 inmates housed in the Camp, inmates are housed in two-man cells.” 

After being ordered by a federal judge to release all records on Paycheck Protection Program loan recipients by November 19, the Small Business Administration is seeking a delay, claiming the release “would do ‘irreparable harm’ to millions of businesses by exposing allegedly confidential information,” The Washington Post reported on Tuesday. Although SBA and the Treasury Department released some information on the program, they have left out the majority of the businesses’ names and specific loan amounts. 

Today’s GovExec Daily podcast episode is about the incoming Biden administration’s priorities for the civil service. 

Help us understand the situation better. Are you a federal employee, contractor or military member with information, concerns, etc. about how your agency is handling the coronavirus? Email us at newstips@govexec.com.