COVID-19 hasn’t slowed anything down when it comes to FDA guidance, as the agency continues to churn out guidance documents at a consistent clip to address both the pandemic and broader drug development issues.
This week’s offerings, so far, include the Sept. 14 release of the FDA’s newest COVID-19 guidance, which is intended to help sponsors consider ways to measure and analyze common coronavirus-related symptoms in clinical trials evaluating drugs to prevent or treat COVID-19 in outpatient adult and adolescent participants.
Recognizing that daily assessment of all COVID-19-related symptoms may not be feasible in a trial, the FDA advised sponsors to identify a minimum number of key symptoms for daily assessments to lessen the burden on trial participants. The guidance provides an example with a set of common COVID-19-related symptoms and an approach to measuring them in trials.
The FDA issued a draft guidance, Sept. 15, to ensure appropriate information on the use of prescription drugs in geriatric patients is consistently placed in the proper labeling section so the information is clear and accessible to prescribers. The draft provides examples of geriatric use statements for labeling and examples of when the FDA may allow applicants to omit or revise specific information otherwise required in the Geriatric Use subsection.
The draft replaces the 2001 “Content and format for geriatric” guidance that has been withdrawn. Comments on the draft should be submitted to docket No. FDA-2020-D-1621 by Nov. 16.
Another guidance released Sept. 15 finalized the FDA’s 2019 draft on developing drugs to treat eosinophilic esophagitis (EoE), a chronic immune or antigen-mediated disease characterized by white blood cell inflammation of the esophagus. Although no drugs have been approved yet to treat EoE, the FDA said there has been an increase in the number of development programs in the space.
The final guidance clarifies the FDA expectations and recommendations for developing EoE drugs and changes how the clinical outcomes assessment portion of the recommended co-primary endpoint data should be analyzed. The change was made “to promote interpretability both within individual development programs and across programs utilizing differing instruments, as well as to increase power of the analyses,” the FDA said.
NIH adds funding to Latino Alzheimer’s research
To better understand the health disparities of brain aging and Alzheimer’s disease between Mexican Americans and non-Latino whites, the NIH said it will provide additional funding for more biomarker measures, including positron emission tomography (PET) imaging, to the ongoing Health and Aging Brain Among Latino Elders (HABLE) Study.
The agency will award about $45.5 million, over five years, to the University of North Texas Health Science Center at Fort Worth for the HABLE-Amyloid, Tau and Neurodegeneration (HABLE AT(N)) Study.
Other studies have suggested that dementia prevalence rates appear to be declining, but most of the evidence is based on studies in non-Latino whites. “It is largely unknown whether these trends extend to under-represented populations,” the NIH said.
Measuring additional biomarkers in the Latino population is expected to “provide important clues to guide approaches to target the right disease processes in the right people at the right time,” said Eliezer Masliah, director of the NIH’s National Institute on Aging’s Division of Neuroscience.
The HABLE study, launched in September 2017, has nearly completed recruitment of 1,000 Mexican Americans and 1,000 non-Latino whites, ages 50 and older. Participants receive a functional exam, clinical labs, neuropsychological testing, bloodwork and a brain MRI. The added funding for HABLE-AT(N) will expand the neuroimaging component of the study to include amyloid and tau PET. Researchers also plan to determine if traces of amyloid peptides, tau, neurofilament light and exosomes in the blood can be used to screen across the spectrum of Alzheimer’s – from asymptomatic to mild cognitive impairment and advanced stages of the disease.
Sprout warned for Addyi promotion
A radio ad promoting Sprout Pharmaceuticals Inc.’s Addyi (flibanserin) as a “pill for women frustrated by their low libido” got the Raleigh, N.C.-based company slapped with an FDA warning letter.
The agency’s Office of Prescription Drug Promotion (OPDP) said the claims in the ad “created a misleading impression regarding the scope of the approved use of Addyi.” In addition, the ad omitted all the contraindications associated with use of the drug and failed to disclose pertinent information about the risks listed in the drug’s boxed warning.
OPDP generally issues untitled letters when pointing out misleading ads, but in this case, it went a step further. The warning letter noted advisory comments OPDP made Aug. 11, 2016, to Sprout’s parent company, Valeant Pharmaceuticals International (now Bausch Health Cos. Inc.). While the letter didn’t detail those comments and redacted the drug involved, it said, “We are concerned that, in the radio ad, Sprout is continuing promotion of Addyi in a manner that does not adequately convey the FDA-approved indication nor the important risk information for the drug.”
Scripps to pay $10M over use of NIH grants
The Scripps Research Institute agreed to pay $10 million to settle a whistleblower suit claiming it improperly used NIH-funded research grants from 2008 to 2016. The institute receives millions of dollars in funding through hundreds of NIH grants each year, according to the U.S. Department of Justice.
The suit, filed by former Scripps employee Thomas Burris, alleged that the institute improperly charged time spent by faculty on developing, preparing and writing new grant applications directly to existing NIH-funded projects rather than allocating the charges as indirect costs.
The suit also claimed Scripps charged NIH-funded grants for time faculty spent teaching, attending institute committee meetings and engaging in other non-grant-related administrative activities. As the whistleblower, Burris will receive $1.75 million.