The Federal Trade Commission abandoned its own standards in arguing that without clinical trials to back Phillips’ Colon Health probiotic claims, Bayer AG violated an earlier settlement on substantiating dietary supplement claims, a federal judge says.
FTC Stretched Standards In Enforcement Against Bayer Probiotic Claim
Judge Jose Linares states in his opinion that FTC’s requirement for “competent and reliable scientific evidence” to substantiate ad claims for consumer health care products aligns with FDA’s regulation of supplement claims under DSHEA, and Bayer complied with both agencies’ regs.
More from United States
Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.
One CDRH employee said the cuts already are having a major effect on morale.
Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
Experts say PBMs should become familiar with transparency rules and prepare to release data, although more legal wrangling could occur.
More from North America
Optum Rx, one of the largest PBMs in the US, declared it was the “first comprehensive, transparent pharmacy services company” after announcing several consumer-friendly changes.
FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."