The House of Representatives has approved and sent to the Senate amendments to strengthen the Freedom of Information Act and to provide protection for whistleblowers.
A significant number of current FDA advisory committee members would be disqualified from participating in future panel deliberations under new guidelines proposed in an agency draft guidance document.
US attorneys in Boston, Philadelphia and San Francisco have issued subpoenas to Johnson & Johnson for marketing materials involving three of its subsidiaries—Ortho-McNeil for Topamax, Janssen for Risperdal and Scios for Natrecor.
“I was misquoted,” asserted FDA commissioner Andrew von Eschenbach in a Capitol Hill hearing that probed FDA transparency and public confidence in March.
Along with high-level apologies for competency failures in the Office of the Attorney General, VA hospitals, FEMA, FBI and many others, we may add the FDA, previously the world’s “gold standard” of health product regulators.