This week we highlight a potential U.S. Food and Drug Administration subpoena amid a probe into overseas inspections. We also look at a divestiture of an early cancer-detection company following a Federal Trade Commission challenge. Additionally, we explore the approval of the first DNA test to identify opioid use disorder, the preparation of artificial intelligence in pharma by European regulators, and biotech’s dependence on Big Pharma for funding.
Each week we highlight five things affecting the life sciences industry. Here’s the latest.
U.S. lawmakers are increasingly concerned about FDA management of drug shortages and its priorities in foreign inspections, reports Fierce Pharma. Following a report that the FDA may have ceased its unannounced foreign inspection program, members of the House Committee on Energy and Commerce are demanding clarity. They attribute recent drug shortages in the U.S., including essential medications, to the FDA’s reduced inspection activities overseas. A significant decline in FDA foreign inspections since 2019, coupled with a rise in regulatory citations, has been noted. Lawmakers are pressing the FDA for detailed answers regarding its inspectional oversight, particularly in relation to operations in certain countries, giving the agency a three-week deadline to respond. This inquiry is part of a broader scrutiny by U.S. lawmakers into the FDA’s role in managing drug shortages and ensuring the safety of pharmaceutical supply chains.
Illumina, a leading medtech company based in San Diego, has announced its decision to divest an early cancer-detection company, Grail, it had acquired for approximately $7 billion. The San Diego Union-Tribune reports that this decision follows a failed legal battle with U.S. antitrust regulators, culminating in a ruling by the Fifth U.S. Circuit Court of Appeals that the deal would reduce competition in the field. Illumina plans to part ways with Grail through a sale or capital markets transaction, aiming to finalize terms by the second quarter of 2024. The FTC had challenged the acquisition on antitrust grounds, arguing that it would limit competition and potentially impact the quality and affordability of cancer detection tests.
The FDA has approved the AvertD test by Autogenomics, the first DNA-based test to assess the risk of developing opioid use disorder, reports MedTech Dive. This approval comes after an FDA advisory committee initially voted against an earlier version of the test in October 2022. The AvertD test, which uses a DNA sample from a cheek swab, is designed to identify genetic variants that may indicate an elevated risk of opioid use disorder. It is intended for use before a patient starts taking oral opioid pain medications for acute pain, such as before planned surgery. The FDA emphasizes that the test should not be the sole basis for treatment decisions and is not intended for patients with chronic pain. As part of the approval, Autogenomics must provide training for providers on using the test and conduct a large post-market study to evaluate its performance. The primary risks associated with the test are false negative and positive results, which could lead to either a false sense of security or inadequate pain management.
The European Medicines Agency and the Heads of Medicines Agencies have developed a coordinated workplan, running until 2028, to integrate AI into pharmaceutical regulation. The European Pharmaceutical Review reports that this plan, prepared by the Big Data Steering Group (BDSG), aims to ensure the European medicines regulatory network remains at the forefront of utilizing AI in medicines regulation. The workplan focuses on enhancing personal productivity, automating processes and systems, increasing data insights, and supporting robust decision-making to benefit public and animal health. The plan emphasizes the development and use of responsible and beneficial AI, acknowledging the rapid evolution of AI technology and its ethical and policy implications. The BDSG plans to regularly update the workplan to keep pace with technological advancements.
In a challenging funding environment, nearly half (48%) of biotech companies are turning to partnerships with Big Pharma as a key financing method, as revealed by an ICON-commissioned survey. Fierce Biotech reports that venture capital firms and government grants/public funding follow as the second and third most common financing sources. The survey, which involved 133 senior-level decision-makers in biotech, highlighted that a majority of these companies are involved in multiple clinical trials, with small molecules and cell therapies being the most prominent drug modalities. Despite financial difficulties, 60% of respondents expect an increase in research and development spending in the next one to two years. The rising cost of capital and advances in digital technology, including AI and machine learning, are seen as significant factors influencing future operations. Confidence levels among biotech leaders vary, with a majority being somewhat confident about meeting their next investment milestones.
Note: We will pause publication of our “5 things” during the holidays. We will resume the week of Jan. 8.
For more insights in life sciences, check out RSM’s industry outlook.