This Week at FDA: Congress passes omnibus spending bill, securing budget increase for FDA

Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we’ve been watching as Congress advances an omnibus spending bill that would provide FDA with a $226 million increase in budget authority and institute reforms for the agency’s accelerated approvals program and cosmetics oversight.
 
In a 225-201 vote, the House passed the $1.65 trillion spending package after the Senate approved the bill on Thursday. President Joe Biden issued a statement following the bill’s passage stating he will “sign it into law as soon as it reaches my desk.” Under the bill, FDA will receive $3.5 billion in budget authority in FY 2023, a 6.5% increase compared to its FY 2022 budget.
 
On Thursday, FDA approved Gilead Sciences’ Sunlenca (lenacapavir) to treat adults with HIV-1 who cannot be treated with other available therapies due to treatment intolerance, drug resistance or due to other safety considerations. “Today’s approval ushers in a new class of antiretroviral drugs that may help patients with HIV who have run out of treatment options,” said Debra Birnkrant, director of the Division of Antivirals in FDA’s Center for Drug Evaluation and Research.
 
The agency also advised drugmakers about the risk of benzene contamination in certain drugs, following multiple recalls of sunscreens and aerosol drugs in recent years. The agency said the source of the contamination may be inactive ingredients in the products, such as carbomers (thickening agents), isobutane (a propellant) or other components made from hydrocarbons.
 
“FDA reminds drug manufacturers they are required to establish scientifically sound and appropriate specifications and test procedures to assure drug components (active and inactive ingredients) and finished drug products conform to appropriate quality specifications,” FDA wrote.
 
Earlier this week, FDA published a one-year review of its Office of Digital Transformation that lists some of its work in modernizing the agency's information technology systems, including adopting more cloud-based systems, enhancing its data infrastructure and focusing on cybersecurity issues.
 
The office also published a Leadership Modernization Action Plan (LMAP), which FDA says aims to improve its information technology capabilities by creating an environment where business and IT programs are aligned, operationalizing IT strategy that reflects the agency's business needs, and developing a pipeline of new technology leaders.
 
The Government Accountability Office (GAO) on Monday released a report on actions taken by federal agencies and non-federal cancer centers to promote diversity in cancer clinical trials.
 
In case you missed it, our Senior Editor Ferdous Al-Faruque spoke with FDA Commissioner Robert Califf at length about his priorities and tenure at the agency. Read the interview here.
 
Drugs & biologics
 
On Tuesday, Department of Health and Human Services (HHS) Secretary Xavier Becerra and Califf met the Consumer Healthcare Products Association (CHPA) and several drugmakers, including Perrigo and Johnson & Johnson to discuss the availability of over-the-counter pediatric medicines amid concerns about potential shortages as the country grapples with simultaneous outbreaks of COVID-19, RSV and flu.
 
“All the companies shared that they are running manufacturing facilities 24-7 to meet demand, supplies of these products are being replenished as quickly as possible, and there is no widespread shortage of pediatric medicines,” said HHS. Becerra also authorized states to access stockpiles of Tamiflu and said states can access the national stockpile of the drug if they lack their own.
 
FDA is seeking feedback on internationally harmonized clinical trial protocol reporting standards that were drafted by the International Council for Harmonisation (ICH) earlier this year. In a Federal Register notice, FDA announced the availability of a draft version of ICH’s M11 Clinical Electronic Structured Harmonised Protocol (CeSHarP) guidance for comment. A draft template and a list of technical specifications meant to be used alongside the guidance were also released for comment. The ICH M11 guidance is meant to harmonize clinical trial protocol templates to ensure sponsors submit consistent reports across global regulatory agencies.
 
FDA issued several warning letters to drugmakers this week, including letters to compounding pharmacy Sagent Pharmaceuticals for “serious deficiencies” related to the company’s production of drugs meant to be sterile, Brazilian drugmaker Nortec Quimica for data integrity issues, DuPont Nutrition USA for issues related to complaint handling and out-of-specification investigations for its excipient Avicel and to clinical investigator Adarsh Daswani, MD, for failing to ensure a clinical study was conducted according to the investigational plan.
 
Reuters reports that the Institute for Clinical and Economic Review (ICER) has issued a draft report finding that Eisai and Biogen’s investigational Alzheimer’s disease drug lecanemab would need to be priced between $8,500 and $20,600 per year to be cost effective.
 
Valneva announced that it has completed its biologics license application (BLA) submission for its single-shot chikungunya vaccine for adults 18 and older.
 
FDA on Friday approved Roche’s bispecific antibody Lunsumio (mosunetuzumab-axgb) to treat patients with relapsed or refractory follicular lymphoma.
 
Qualgen, an Oklahoma-based drug compounder, settled a case brought against it by FDA for failing to maintain current good manufacturing (CMG) practices. A consent decree was entered against the company by a US District Court that prohibits Qualgen from directly or indirectly distributing adulterated drugs in interstate commerce.
 
Medtech
 
This week, FDA updated a web page detailing when manufacturers are exempt from reporting certain adverse events in their Medical Device Reporting (MDR) submissions. The agency notes that the exemptions are related to events identified in certain real-world data (RWD) sources and details the process for requesting such exemptions.
 
Earlier this week, the Department of Justice (DOJ) announced that medical device maker Advanced Bionics LLC will pay more than $12 million to address false claims about its cochlear implant processors. The announcement said the company “misled federal healthcare programs regarding the radio-frequency (RF) emissions generated” its Neptune and Naida cochlear implant processors.
 
“Advanced Bionics allegedly represented that its processors satisfied an internationally recognized emissions standard when, in fact, Advanced Bionics did not comply with that standard. More specifically, Advanced Bionics allegedly failed to honor the standard’s requirements to test processors using “worst-case” configurations, and improperly shielded certain emissions-generating system components during emissions testing. Advanced Bionics then allegedly sought reimbursement from Medicare, Medicaid, and other federally funded healthcare programs for these devices,” DOJ wrote.
 
FDA issued a safety communication this week detailing potential safety issues with some reworked Philips Respironics Trilogy 100 and Trilogy 200 ventilators. The devices were first recalled in June 2021 because the polyester-based polyurethane (PE-PUR) sound abatement foam used could break down and block the devices’ air pathway. Regulators now warn that the reworked foam may separate from the plastic backing due to adhesive failure, and there may be some residual foam left in the devices.
 
Arrow International, a subsidiary of Teleflex, is recalling its Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps after receiving complaints that the devices’ battery power is depleting too fast, according to FDA. The agency warned that if the device stops working prematurely due to lack of battery power, it could mean patients suffer a cardiac arrest, stroke, and death.
 
Pfizer and Anumana, a Mayo Clinic health technology startup, announced a research agreement to develop an algorithm using electrocardiogram (ECG) data to identify patients who may be at risk of cardiac amyloidosis. Anumana is tasked with validating the algorithm in a clinical trial and for submitting a de novo premarket application with FDA.