UTAH MEDICAL PETITIONS HHS OVER 'ABUSIVE' FDA PRACTICES
After winning a lawsuit against the FDA, Utah Medical Products is taking another step in its battle with the agency, filing a petition with HHS saying the FDA should remove a two-year-old press release about the firm from its website.
Utah Medical, which focuses on gynecological and neonatal products, has also asked HHS to review the firm's allegations that FDA inspectors and staff were overly aggressive -- even "abusive" -- in enforcing the agency's quality system regulation (QSR).
The matter goes back to August 2004, when the FDA issued a press release alleging that the Utah plant was not in compliance with QSR.
But a federal court last October ruled that the company was in compliance with QSR. Utah Medical's newest claim asks that the FDA remove the Aug. 10, 2004, press release from its website. It also asks that the FDA inspectors and reviewers involved in the company's plant inspections between 2001 and 2003 be barred from any future involvement with Utah Medical.
"We hope the record, which is incorrect now, is corrected, and thereby clears up any misunderstanding that the company may not be in compliance -- because we are," Utah Medical CEO Kevin Cornwell said. "The court was very clear that we have been and are in compliance.