Each week we highlight five things affecting the life sciences industry. Here’s the latest.
FDA releases final rule on laboratory developed tests
- 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.
Decline in pharma’s post-pandemic reputation
- 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 discloses cost of tuberculosis clinical trial
- 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.
FTC clamps down on improper or inaccurate patents in pharma
- 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.
U.S. biopharma’s reliance on Chinese CDMOs under scrutiny
- 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.
