FDA announces voucher program to speed drug reviews

News brief

FDA headquarters — Grandbrothers / iStock

The US Food and Drug Administration (FDA) yesterday announced the launch of a new voucher program, saying it will shorten the review time for new drugs.

Under the Commissioner's National Priority Voucher (CNPV) program, companies "aligned with US priorities" will be able to submit information for a new drug application to a multidisciplinary team of physicians and scientists for pre-review before clinical trials have been completed. The FDA commissioner may also grant accelerated approval to drugs that meet the applicable legal requirements.

The FDA says the CNPV program, which will start this year in a limited 1-year pilot phase, will shorten review time from 10 to 12 months to 1 to 2 months following a sponsor's final drug application submission.

"Using a common-sense approach, the national priority review program will allow companies to submit the lion's share of the drug application before a clinical trial is complete so that we can reduce inefficiencies," FDA Commissioner Marty Makary, MD, MPH, said in an agency news release. "The ultimate goal is to bring more cures and meaningful treatments to the American public."

Criteria for eligibility

The commissioner will consider companies eligible for the voucher program if they are addressing a health crisis in the United States, delivering more innovative cures to the American people, addressing unmet public health needs, and increasing domestic drug manufacturing as a national security issue.

The vouchers can be used for a specific investigational new drug at any stage of its development or can be granted to companies as an undesignated voucher that they can use at their discretion.

The FDA's existing Priority Review and Priority Review Voucher programs will continue as is.

Analysis highlights bacterial contamination, multidrug-resistance, in retail meat samples

News brief

Chris Dall, MA

Packaged chicken in grocery store — nastya_ph / iStock

Over one-third of US retail meat samples tested positive for at least one type of potentially harmful bacteria, and nearly 1 in 4 bacterial isolates collected were multidrug-resistant (MDR), according to an analysis of Food and Drug Administration (FDA) data.

The review by TraceOne, a company that makes regulatory compliance software for the food and beverage industry, analyzed data for 2019 through 2021 from the FDA's National Antimicrobial Resistance Monitoring System (NARMS), which collects data on enteric bacteria found in people, retail meat samples, and animals at slaughter. NARMS focuses on bacteria that are associated with foodborne illness, such as Salmonella, Escherichia coli, and Campylobacter. It also collects data on Enterococcus, which can indicate fecal contamination.

"Meat can become contaminated with these bacteria at several points during the production process—most often during slaughter, handling, or packaging," the report notes. "Bacteria from the animal’s intestinal tract can spread to the meat surface if sanitation procedures are not strictly followed."

Highest rates of Salmonella, Campylobacter found in chicken

The data show that 36 % of meat samples (ground beef, ground turkey, chicken, and pork chops) tested positive for bacteria. Chicken samples harbored the highest rates of Salmonella and Campylobacter (17.9% and 17.1%, respectively), the two bacterial pathogens most commonly associated with foodborne illness, while ground turkey had the highest rate of E coli (67.2%) and notably high levels of Salmonella (11.4%).

The analysis also found that nearly a quarter (22.8%) of bacterial isolates obtained from the retail meat samples were resistant to three or more antibiotic classes. Ground turkey had the highest overall MDR rate (29.7%), while chicken meat had the highest rate of MDR Salmonella (39.1%) and an overall MDR rate of 25.6%. Among all bacteria, Salmonella had the highest overall MDR rate at 35.5%, followed by E coli (26.0%), Enterococcus (15.3%), and Campylobacter (13.6%).

Analysis of geographic differences in food safety, based on meat-bacteria combinations consistently tested across all states, revealed that the top five states for overall contamination risk were Georgia, South Carolina, Tennessee, Minnesota, and Pennsylvania.

Cytomegalovirus reactivates in significant proportion of COVID-19 patients

News brief

Stephanie Soucheray, MA

A new preprint study suggests reactivation of CMV, or cytomegalovirus, is prevalent in COVID-19 patients treated in the intensive care units (ICUs). The authors of the study said this finding should prompt consideration of early antiviral treatment in ICU patients.

CMV reactivation is tied to severe illness, immunosuppression, and dysregulated inflammation, but most commonly studied in the context of sepsis. The authors said the influx of intensive care needed for COVID patients since the first year of the pandemic likely resulted in significant CMV reactivation numbers.

The study is based on a prospective cohort of concomitant ICU patients with and without COVID-19, who were monitored for CMV DNA during their hospitalization. In total 160 adult ICU (78 COVID-19, and 82 concomitant non-COVID-19) patients were monitored weekly for CMV DNA.

High-dose steroids linked to CMV

“Overall, 30.6% of ICU patients experienced CMV reactivation, with 10% exhibiting clinically-significant reactivation,” the authors said. COVID-19 ICU patients had significantly higher rates of any CMV reactivation (41% vs. 20.7%) and CMV disease (8.9% vs. 1.2%) compared to concomitant non-COVID-19 patients.

COVID-19 patients treated with high-dose steroids were particularly at risk for CMV reactivation, which may be related to the central role of T-cells in CMV immune control.

Together with the worse clinical outcomes linked to CMV reactivation, the findings highlight the need for vigilant monitoring of CMV reactivation.

“Together with the worse clinical outcomes linked to CMV reactivation, the findings highlight the need for vigilant monitoring of CMV reactivation and consideration of early antiviral treatment in ICU patients at risk, and support future interventional trials,” the authors concluded.