Each week we highlight five things affecting the life sciences industry. Here’s the latest.
How will the FDA be affected by the Chevron ruling?
- The Supreme Court’s decision to overturn the Chevron doctrine reduces judicial deference to federal agency interpretations of ambiguous statutes, potentially leading to more challenges to Food and Drug Administration regulations, including the rule on lab-developed tests (LDTs), MedTech Dive reports.
- Legal experts anticipate increased litigation against the FDA, with some expecting significant implications for regulatory areas involving LDTs, artificial intelligence and software as medical devices, although product approval and recall processes are likely to remain largely unaffected.
Senate unanimously passed bill limiting patent protection for pharmaceuticals
- The U.S. Senate unanimously passed a pharma patent reform bill to promote generic and biosimilar competition, which aims to lower prescription drug costs by limiting the number of patents pharma companies can assert in infringement litigation, according to BioSpace.
- The Pharmaceutical Care Management Association, a group that represents pharmacy benefit managers (PBMs), supports the bill for addressing anti-competitive practices like patent thickets, while the Federal Trade Commission highlighted the significant role of PBMs in inflating drug prices.
GLP-1 drugs continue to show potential benefits beyond weight loss
- A recent study indicated that GLP-1 medications may be associated with a reduced risk of several obesity-linked cancers, including gallbladder, pancreatic and liver cancer, according to ABC news.
- GLP-1 drugs have also shown potential benefits for conditions such as alcohol use disorder, kidney disease and anxiety, though side effects like nausea, constipation and possible gallbladder or pancreatic issues warrant careful consideration and discussion with health care professionals.
Study shows potential for AI to increase efficiency in trial enrollment
- According to Fierce Biotech, researchers at Mass General Brigham found that AI software can accurately and efficiently screen patients for clinical trial eligibility by analyzing electronic medical records, achieving an accuracy rate of 97.9% to 100% compared to expert clinicians and significantly reducing costs.
- While AI shows promise in improving clinical trial screening processes, the researchers caution that its implementation must include safeguards to prevent biases and errors, and should involve human oversight to ensure safety, effectiveness and equity.
House to vote on BIOSECURE Act this year
- U.S. House Speaker Mike Johnson pledged to hold a vote on the BIOSECURE Act before the end of the year, aiming to halt federal contracts with Chinese biotech companies over national security concerns. Despite bipartisan support, previous attempts to pass the bill as an amendment to the 2025 National Defense Authorization Act failed, and while passing it as a standalone bill is difficult, Johnson continues to push for it, Fierce Pharma reports.
- The bill could require U.S. drugmakers to cut ties with Chinese contractors by 2032 to retain Medicare and Medicaid spots.
For more insights in life sciences, check out RSM’s industry outlook.
