Each week we highlight five things affecting the life sciences industry. Here’s the latest.
- On April 29, the U.S. Food and Drug Administration issued a final rule regarding regulation of laboratory developed tests, following a proposed rule in the fall of 2023.
- A key area of the final rule relates to enforcement discretion, with the FDA noting that they will exercise discretion with devices currently marketed as well as those being used within a health care system.
- Fierce Pharma reports that pharma’s reputation has fallen for the first time since 2018, as assessed by a PatientView survey, with only 57% of patient groups now viewing the industry positively, down from higher ratings in previous years.
- Criticisms focus on pricing, patient engagement in research and development, and access to medicines, with significant negative shifts in views notably in the U.S., Finland and Ireland.
- Doctors Without Borders/Médecins Sans Frontières (MSF) disclosed the costs of their TB PRACTECAL clinical trial, approximately $36 million, to promote transparency in medical research and development.
- MSF advocates for increased transparency to improve access to medical tools and to challenge the high pricing justified by hidden research and development costs.
- BioSpace reports that the U.S. Federal Trade Commission has issued warnings to 10 pharmaceutical companies, challenging patents they claim are improperly listed in the FDA’s Orange Book.
- This action is part of broader efforts to combat practices that allegedly inflate drug prices and hinder competition.
- Fierce Pharma reports that the Biotechnology Innovation Organization is conducting a survey to quantify U.S. biopharma’s reliance on Chinese contract development and manufacturing organizations (CDMOs), amid legislative pressures to reduce dependence.
- The survey aims to inform policy makers and ensure uninterrupted patient access to medicines against a backdrop of potential legislative actions that could restrict U.S. ties with Chinese biotech firms.
For more insights in life sciences, check out RSM’s industry outlook.