The FDA has made strengthening the safety and integrity of the global drug supply chain one of its top four strategic priorities for FY2011-2015, and is seeking public comment on refining these agency-wide goals.
Community Catalyst, which has been working with the Pew Prescription Project and the Alliance for a Safe Drug Supply to secure the global supply chain through legislative and regulatory measures, has been supportive of the agency’s efforts and applauds the prioritization of these critical issues now. The groups plan to comment in support of them.
In FDA’s draft strategy document, the agency said it aims to improve its oversight capacity by expanding risk-based quality checks, ensure that drugs being manufactured conform to established quality standards, and build good communication lines so the public is kept informed of drug quality and safety issues that arise.
Establishing better supply chain controls, the agency said, will entail coordination among foreign, federal and state regulators, gathering more and higher quality information from companies about their supply chains, and improving enforcement and inspection duties – which means newer tools and equipment, more inspection resources and the adoption of newer technology systems (read: FDA needs new computers.)
The FDA is already taking steps in this direction. It is working to prioritize follow-up with companies after warning letters and other enforcement actions have been issued, and developing deadlines by which drug makers must respond to critical or problematic inspection results.
The agency has also gone before Congress numerous times in the past two years to ask for more inspection resources and regulatory authority. Several bills before Congress now, including the Drug Safety and Accountability Act in the Senate, and a draft bill from the House Energy and Commerce Committee, would give the agency those things, among others.
Read more on Community Catalyst and Pew Prescription Project efforts to secure a safe drug supply here.
–Kate Petersen, PostScript blogger