New Legislation to Boost FDA's Inspection and Enforcement Authority
On April 24, Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) introduced The Drug and Device Accountability Act of 2009, which would give the FDA more resources for conducting foreign drug plant inspections and the power to issue subpoenas.
On April 24, Senators Charles Grassley (R-IA) and Edward Kennedy (D-MA) introduced The Drug and Device Accountability Act of 2009, which would give the FDA more resources for conducting foreign drug plant inspections and the power to issue subpoenas.
The bill would augment the FDA’s resources through the collection of inspection fees, which would be used for more foreign drug plant inspections. It also requires individuals responsible for submitting drug and device applications to certify that the submissions are not false or misleading and comply with applicable regulations. Civil and criminal penalties could be imposed for false or misleading certifications.
“An increasing number of drugs and ingredients for pharmaceuticals are being manufactured in other countries, yet studies show the FDA doesn't know how many foreign plants are subject to inspection, and the FDA conducts relatively few foreign inspections each year,” Grassley said in floor statement about the bill. “Our legislation is a practical solution to beefing up the FDA's inspection work, both domestically and abroad, and holding the FDA accountable for its review of medical devices, where questions have been raised about the agency's work,” he added.
The FDA has been chastised for its lack of inspections of foreign plants after failing to stop shipments of contaminated heparin from China, which led to allergic reactions, deaths, and a subsequent recall in 2008. The new bill is similar to the legislation introduced last year by Grassley and Kennedy and would expand the FDA’s inspection and enforcement authority.
View Grassley’s full floor statement detailing the need for this legislation.http://grassley.senate.gov/news/Article.cfm?customel_dataPageID_1502=20314
View BioPharm International’s coverage of the heparin incident.http://biopharminternational.findpharma.com/biopharm/News/Heparin-Contamination-More-Widespread-than-First-T/ArticleStandard/Article/detail/511693
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
