Outlining its priorities for the next four years, the FDA asked clearly last week for new authorities and resources to help the agency move to a proactive, preventive model aimed at keeping the global drug supply safe, rather than the border-busting and warning-letter mode it often relies on now.
In a bold and long-vision document that Community Catalyst backed in alliance with major medical, manufacturer and consumer groups, the agency says it will need nothing less than a ‘’paradigm shift” to make the ever-expanding global drug supply safer as it makes its way to American pharmacy shelves and medicine cabinets.
The agency said it needs:
- resources for boosting inspection and testing efforts
- innovative 21st-century compliance and enforcement tools
- a “global alliance of regulators” who share standards and goals for what safe drug manufacture looks like and how to achieve it
- better information systems to collect, track, and manage safety data
- better coordination with standards-setting agencies (such as the USP) and foreign and state regulators.
A new bill before Congress would go a long way to helping the agency get there. The Drug Safety Enhancement Act, introduced earlier this month, would increase resources for inspections and information systems, as well as add muscle to the agency’s enforcement arm with important recall and subpoena authorities to get risky drugs off the market faster and get the information it needs when things do go wrong.
The agency wrote:
The growing challenges of globalization have far outstripped the FDA’s resources for inspection and quality monitoring, and the inability to maintain adequate oversight means potential risk to consumers grows every year. Addressing these challenges will require a paradigm shift — to a focus on prevention, on stopping threats before they ever become reality. The border must be viewed as a final checkpoint for preventive controls, rather than the primary line of defense against unsafe imports.
You can read about our comments of support and our campaign for safer drugs at this earlier post, and watch FDA Deputy Commissioner John Taylor talk about FDA’s five-year plan and priorities at the Pew Health Group’s After Heparin conference in March.
–Kate Petersen, PostScript blogger