This Week at FDA: New House speaker and NIH director, Califf goes to India

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. The US House of Representatives finally has a new speaker, FDA Commissioner Robert Califf discussed the importance of India’s generic drug manufacturing sector, and a Senate committee moved forward with a new NIH director.

Three weeks after Rep. Kevin McCarthy, R-CA, was ousted as Speaker of the House of Representatives, Rep. Mike Johnson, R-LA, was elected to the position by his colleagues and immediately set about getting back to business.

As Steve Grossman at the Alliance for a Stronger FDA noted in a blog post, Johnson has proposed to extend the current Continuing Resolution into 2024 to allow lawmakers on both sides of the aisle more time to negotiate a budget deal. He also proposed creating a working group to evaluate concerns about the agriculture, rural development, and Food and Drug Administration (FDA) appropriations bill. Finally, he set out a plan that includes the appropriations bill coming before the full House by 13 November.

POLITICO noted that Johnson has supported strict anti-abortion policies that make no exceptions for rape, incest, or when the mother's life is at risk. As a majority of House Republicans support legislation to stop FDA from allowing mail-order delivery of the abortion drug mifepristone, the new speaker could be a key factor in whether they are successful.

Moving from Capitol Hill to Bethesda, MD, Monica Bertagnolli is one step closer to becoming director of the National Institutes of Health, now that her nomination has been approved by the Senate Health, Education, Labor and Pensions Committee. Her nomination was held up for a time by Sen. Bernie Sanders, I-VT, the committee’s chairman, over concerns that she is not likely to take on the pharmaceutical industry to lower drug prices. Her nomination now advances to the full Senate for confirmation.

Rep. James Comer, R-KY, wrote to the Federal Trade Commission (FTC) this week asking for communications between itself, the European Commission, and other foreign jurisdictions regarding the Illumina and Grail merger. The chairman of the House Committee on Oversight and Accountability said emails obtained through the Freedom of Information Act (FOIA) allude to collusion between FTC and European regulators to stop the merger.

The US International Trade Commission (USITC) published a report on how the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has affected medical products developed to diagnose and treat COVID-19. The report is in response to a request from the US Trade Representative and includes information such as the impact of TRIPS on industry, trade, countries, and pricing.

This week was a little quieter on the guidance front. FDA published three, including a revised draft guidance on promoting off-label uses of medical products, a final guidance on its enforcement policy for remote monitoring devices, and a draft guidance on generic topical dermatologic corticosteroid products.

Drugs & Biologics

FDA Commissioner Robert Califf penned a blog post this week summarizing his recent visit to India, where he discussed the country's importance to the US as a generic drugs manufacturing hub. He said he impressed Indian regulatory authorities and other stakeholders on the importance of ensuring current good manufacturing practices (CGMP) and prioritizing a culture of quality. The commissioner also repeated past statements that investors are finding it hard to invest in the industry with increasingly small profit margins.

The Centers for Disease Control and Prevention (CDC) issued a health alert this week asking clinicians to ration Beyfortus (nirsevimab), Sanofi and AstraZeneca's respiratory syncytial virus (RSV) immunization product for infants at highest risk for contracting the disease due to limited supply. The alert comes after CDC’s Advisory Committee on Immunization Practices (ACIP) recommended that Beyfortus be prioritized for infants under 8 months, and for those between 8 and 19 months if they are at high risk. The agency said it is working with the manufacturers to improve supply of the vaccines.

Medtech

FDA, along with regulators in Canada and the UK published five guiding principles that sponsors of machine learning-enabled medical devices that use predetermined change control plans (PCCP) can use to ensure the meet regulatory muster. The agency noted that while the principles were directed at artificial intelligence/ machine learning (AI/ML) products, they could potentially also be used for other medtech products that use PCCPs.

FDA has updated its Manufacturer and User Facility Device Experience (MAUDE) Database and openFDA to include additional patient demographics data. More specifically, the agency said it has added fields such as age, weight, ethnicity, and race. Regulators added that the intention is to ensure adverse event reports are more informative to the public.

Insulet announced it has received 510(k) clearance for its Omnipod 5 Automated Insulin Delivery System application for Apple iPhones, which allows patients to control their insulin pumps such as the Dexcom G6 Continuous Glucose Monitoring System. The app was already cleared for Android phones, but the company says the new app has additional functions, such as new custom food features.

Medtronic announced its extravascular implantable cardioverter-defibrillator Aurora EV-ICD MRI SureScan and defibrillation lead Epsila EV MRI SureScan has been approved to treat fast heart rhythms that may cause sudden cardiac arrest (SCA). The company said that unlike traditional ICD's, the devices are minimally invasive where the Aurora is implanted under the left armpit and the Epsila is inserted under the breastbone.

This Week at FDA: New House speaker and NIH director, Califf goes to India

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