Lawmakers ask FDA for information on US drug shortages

News brief
Empty pill bottles
Haley Lawrence / Unsplash

In response to continuing US drug shortages, two lawmakers have asked the Food and Drug Administration (FDA) to provide information on the country's continuing drug shortages.

"The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves," House Committee on Oversight and Accountability Chairman James Comer (R-Ky) and Subcommittee on Health Care and Financial Services Chairwoman Lisa McClain (R-Mich) wrote in a letter yesterday to FDA Commissioner Robert Califf, MD.

Problem preceded pandemic

Noting that the FDA's database lists 128 drugs as in shortage, Comer and McClain asked for a number of documents and a staff-level briefing to better understand the FDA's role in drug-shortage monitoring and prevention.

"Current shortages include important drugs commonly used to treat infections, respiratory illnesses, heart failure, psychiatric conditions, and cancer, and include drugs such as amoxicillin, penicillin, albuterol, Adderall, and cisplatin/carboplatin," they wrote. "Earlier this year, there was a shortage of children's acetaminophen and ibuprofen. The cancer drug shortage has gotten so severe that the FDA temporary authorized the importation of drugs produced by non-FDA approved Chinese manufacturers."

The FDA is failing to ensure vitally important pharmaceuticals remain on pharmacy shelves.

The lawmakers said the shortage of critical drugs preceded the COVID-19 pandemic. "There are a variety of reasons for the current state of drug shortages apart from pandemic supply chain delays, including an over-reliance on offshore manufacturing facilities, surging demand for pharmaceuticals, and diminishing manufacturing of generics," they wrote.

Comer and McClain said they fear that the mandated price controls included in the Inflation Reduction Act will worsen drug shortages by leading to less investment in domestic drug production and limit pharmaceutical firms' ability to invest in developing new therapies. They said illegal pharmacies may take advantage of the shortages, to patients' detriment.

"Desperation may drive consumers to purchase illegal or counterfeit drugs distributed without the supervision of a licensed pharmacist," they wrote. "It is of vital importance that the FDA monitor and prevent future drug shortages to maintain Americans' health and quality of life."

Fewer US workers sick with flu, COVID went to workplace after pandemic began

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Stressed man working
Prostock-Studio / iStock

US workers ill with influenza or COVID-19 were less likely to work onsite than those with other acute respiratory infections (ARIs) after the pandemic than before, concludes a study led by Centers for Disease Control and Prevention (CDC) researchers.

For the study, published yesterday in Emerging Infectious Diseases, the researchers analyzed data from participants in the seven-state US Influenza Vaccine Effectiveness Network who had ARIs from 2018 to 2022.

Participants, who were aged 19 to 64 years, completed a follow-up survey 1 or 2 weeks after enrollment and were asked about their health and work. Network sites were located in Michigan, Pennsylvania, Texas, Washington, California, Wisconsin, and Tennessee.

Prepandemic hybrid workers more likely to stay home

During the pre-COVID flu seasons, 1,245 people had confirmed flu and 2,362 had other ARIs. During the pandemic, 114 people had flu, 1,888 had COVID-19, and 2,523 had other ARIs. Among those with any ARI, 82.6% with flu, 61.4% with COVID-19, and 49.6% with other ARIs reported having fever.

Of all participants, 14.0% had worked only remotely before illness, 18.5% had hybrid experience, and 67.5% had worked onsite only.

On the third day of illness, 18.5% of participants worked remotely during the pandemic, compared with 8.8% before. In prepandemic flu seasons, 64.4% of workers with flu and 40.3% of with other ARIs worked offsite. Amid the pandemic, 66.7% of employees with COVID-19 and 48.3% with other ARIs didn't go to work.

Hybrid and remote work policies might reduce workplace exposures and help control spread of respiratory viruses.

Relative to employees without hybrid work experience, those who worked remotely were significantly more likely to telework, an effect more pronounced amid COVID-19 than during prepandemic flu seasons. In contrast, workers who had worked only onsite were more likely to not work at all on their scheduled days.

Employees with COVID-19 or flu were less likely to go to work than people with other ARIs. Few people who tested positive for COVID-19 by the second or third day of symptoms worked onsite.

"Hybrid and remote work policies might reduce workplace exposures and help control spread of respiratory viruses," the authors wrote.

Fecal microbiota transplantation promotes reduction of resistant bacteria, trial finds

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Data from a small randomized clinical trial indicate that fecal microbiota transplantation can reduce multidrug-resistant organism (MDRO) colonization in kidney transplant recipients, researchers reported this week in Science Translational Medicine.

In the phase 1 trial, a team led by investigators from Emory University School of Medicine enrolled and randomized 11 renal transplant recipients (RTRs) to receive FMT—a procedure in which stool from a healthy donor is transplanted to a patient—or an observation period followed by delayed FMT if stool cultures were MDRO positive at day 36. Kidney transplant patients are at high risk for MDRO colonization and infection, because they receive prophylactic antibiotics after transplant, which can select for MDROs. They are thus a priority for decolonization, because many of the antibiotics used to treat MDRO infections are nephrotoxic.

All 11 patients ultimately received at least one dose of FMT, with 9 receiving two treatments. While no participants in the observation group had spontaneous MDRO decolonization, 4 of 6 participants randomized to the FMT group were MDRO-negative after one dose, and 8 of 9 participants who received all protocol-specified FMTs were MDRO-negative by their last visit. In addition, at 180 days, FMT-treated participants had a longer time to recurrent MDRO infection compared with a control group of renal transplant recipients who did not receive FMT.

Bacterial strain competition

Analysis of Escherichia coli isolates from a subset of the FMT treatment group found that, rather than simply eradicating the MDRO strains, FMT appeared to promote competition with antibiotic-susceptible E coli strains that were present in the patients prior to FMT, with the susceptible strains replacing the MDRO strains.

"We conclude that microbiome therapies like FMT may provide a path to exploit bacterial strain competition to eradicate MDRO colonization," the authors wrote. "This trial also provided evidence that reducing MDRO colonization in RTRs could reduce recurrence of MDRO infections, which has broad potential to improve patient care and public health response and to reduce health care costs in patient groups beyond SOT [solid organ transplant] recipients."

We conclude that microbiome therapies like FMT may provide a path to exploit bacterial strain competition to eradicate MDRO colonization

Quick takes: US COVID steady but flu up a bit, more avian flu outbreaks, new polio cases

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  • US COVID-19 activity last week was mostly level, with emergency department visits for the disease down 5%, the Centers for Disease Control and Prevention (CDC) said today in its weekly update. The percentage of tests registering positive for SARS-CoV-2 was 9.0%, unchanged from the week before. The country logged 15,745 COVID hospitalizations, up 0.1%, and 2.5% of all US deaths were caused by SARS-CoV-2, the same as the previous week. COVID-19 emergency visits, however, were up 5.2%. Some counties in some states in the West and Midwest reported high hospitalization levels—20 or more cases per 100,000 population.
  • Influenza-like illness (ILI) among outpatients—one of the leading indicators the CDC uses to track the flu season—were up slightly last week, and the country has had its first flu-related death in a child this flu season, the CDC said in its weekly update today. The percentage of ILI among nonhospitalized patients was 2.7%, up from 2.5% the week before but still below the baseline of 2.9%. Of respiratory samples tested in clinical labs, 1.9% were positive for influenza, the same as the week before. Of all US deaths, 0.06% were attributed to flu. The CDC reported 3 pediatric flu deaths today, but 2 of them were from last season, bringing the 2022-23 total to 181. The predominant circulating strain continues to be 2009 H1N1.
  • Highly pathogenic avian flu outbreaks have been reported in commercial and outdoor flocks in seven states in recent days, according to the latest update from the US Department of Agriculture Animal and Plant Health Inspection Service (APHIS). The outbreaks have hit commercial broiler farms in Alabama and Arkansas; turkey farms in Iowa, Minnesota, and South Dakota; and backyard flocks in Oklahoma and Tennessee. Fifteen states have been affected by outbreaks over the past 30 days, and 60.23 million birds have been affected since the H5N1 strain first turned up in US poultry in early 2022. In international developments, the World Organization for Animal Health reported an H5N1 outbreak at a poultry processor in Mexico, and Avian Flu Diary reported a third H5N1 infection at a Finnish mink farm.
  • Five countries reported polio cases this week, according to the latest update from the Global Polio Eradication Initiative. Cases of circulating vaccine-derived poliovirus type 2 (cVDPV2) were reported in Central African Republic (1), Democratic Republic of the Congo (3), Kenya (2), Nigeria (9), and Somalia (1). DR Congo also reported one case of circulating vaccine-derived poliovirus type 1.

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