This Week at FDA: Califf calls for adcomm reform, first OTC naloxone may be on horizon

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, FDA Commissioner Robert Califf called for reforming the agency’s advisory committee system, experts gave a thumbs up to potentially the first OTC opioid overdose drug and more.
 
Speaking at the Biopharma Congress meeting in Washington, DC, Califf said that the Food and Drug Administration advisory committee system needs to be changed to allow fuller and more comprehensive discussion of the issues surrounding the approval of a medical product under review.
 
“The purpose of the advisory committee is not to produce gladiator votes, so people say the FDA does not agree with its advisory committees,” he said. “The purpose is to get advice, and the best advice is not whether this drug should be approved. That decision should be made by full-time civil servants.”
 
Califf also announced this week a report reviewing FDA’s external opioid-related activities, which included recommendations for transparency around the its opioid analgesic regulatory decisions as well as asking Congress for additional authorities to fight the opioid crisis.
 
On the topic of advisory committees and opioid analgesics, an FDA advisory committee this week met this week to offer perspective on an over-the-counter (OTC) naloxone product as emergency treatment of opioid overdoses. The panelists voted unanimously to recommend approving the nasal spray made by Emergent BioSolutions. They also suggested packaging changes to improve consumer understanding of to use the product, according to reporting from MedPage Today.
 
As the new Congress gets down to work, the New York Times published (subscription required) an interesting profile on Sen. Bernie Sanders, I-VT, who now leads the powerful Senate Health, Energy, Labor and Pensions (HELP) committee. The self-proclaimed social democrat has a history of criticizing profits made by drug companies and has vowed to address growing drug prices.
 
On the issue of drug prices, the Department of Health and Human Services (HHS) has picked three new models for testing by the Center for Medicare and Medicaid Services’ Innovation Center to help lower drugs prices, promote accessibility to life-changing drug therapies, and improve quality of care, according to a CMS statement. The action comes in response to President Biden’s Executive Order 14087, “Lowering Prescription Drug Costs for Americans.”
 
Axios is reporting that US House Republican leaders are gearing up to investigate how COVID-19 vaccine funding was distributed by the government. The House Oversight Select Subcommittee on the Coronavirus Pandemic may investigate a broad range of pandemic-related topics, including the virus’ origins, federal COVID-19 restrictions, and its economic impact.
 
The US International Trade Commission (USTR) also says it plans to review COVID-19 patent policy. The commission says it is reviewing a World Trade Organization (WTO) proposal that would result in weaker patent protections for COVID-19 diagnostics and therapeutics and plans to hold a public meeting on the topic in March, according to reporting from Medtech Insight.
 
The Government Accountability Office (GAO) published a report that makes four recommendations regarding Institutional Review Boards (IRB). More specifically, it recommends that HHS and FDA conduct annual risk assessments to determine if the agencies are routinely inspecting an adequate number of IRBs and to optimize the use of inspections in the oversight of IRBs and protection of research participants, and examine and implement approaches for measuring IRB effectiveness.
 
Drugs & Biologics
 
This week the FDA published a guidance on product-specific guidance (PSG) meetings between FDA and sponsors submitting an abbreviated new drug application (ANDA). It provides information on how to request and conduct PSG meetings with the agency as agreed under the Generic Drug User Fee Amendments (GDUFA III) deal.
 
The FDA also published a webpage that explains important elements in the GDUFA III commitment letter regarding ANDA assessments and goal dates. The agency plans to update the page with links to guidances, manuals of policy and procedures (MAPPs), and other resources, such as explanatory presentations.
 
The agency also approved Lamzede (velmanase alfa), the first enzyme replacement therapy to treat non-central nervous system manifestations of alpha-mannosidosis, a rare genetic condition. According to the FDA, the drug acts the same way as the alpha-mannosidase enzyme in the human body by restoring normal cellular activity in patients.
 
The FDA put out a revised guidance expanding supply of a specific form of ibuprofen, the active ingredient in OTC non-steroidal anti-inflammatory drug medicines such as Advil. The agency will allow outsourcing facilities to provide compounded, orally suspended forms of ibuprofen to state-licensed pharmacies that can be given to patients at home, provided that a patient has a valid and patient-specific prescription.
 
Medtech
 
The largest medical devices manufacturer in the world, Medtronic, was ordered to pay $106.5 million for infringing a transcatheter aortic valve replacement (TAVR) patent from Colibri. Colibri filed the suit in 2019 and accused Medtronic of infringing on patents related to the delivery and controlled release of replacement heart valves in the Colibri Heart Valve.
 
The FDA announced that GE HealthCare is recalling the Nuclear Medicine 600 and 800 Series systems after report of an issue with two mechanisms that prevent uncontrolled detector movement. The agency said there is a risk that the ball screw that serves as design mitigation for the suspended mass of the detector may fail and some devices are also missing a safety key that should prevent the detector from a catastrophic fall when the ball screw fails that could lead to serious injury or death.