FDA Releases Strategic Priorities for 2011-2015 - Pharmaceutical Technology

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FDA Releases Strategic Priorities for 2011-2015


ePT--the Electronic Newsletter of Pharmaceutical Technology

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FDA has released a list of its strategic priorities for the next five years to address new global challenges. The document, titled “Strategic Priorities 2011–2015: Responding to the Public Health Challenges of the 21st Century”, provides a vision for FDA. This vision includes a new field of regulatory science that uses innovations in science and technology to ensure the safety and effectiveness of products, according to the document, which also includes proposals for meeting the needs of the world’s unique populations.

FDA Commissioner Margaret A. Hamburg said in a press release about the strategic priorities that FDA’s job is “fundamentally different” than it has been in previous eras, but that the agency will “address these challenges and aim to fulfill our mission by embracing innovation and actively pursuing partnerships with federal, state, and local agencies, international authorities, academia, non-government organizations, and the private sector.”

The strategic plan outlines five cross-cutting strategic priorities that the agency will aim to carry out over the next five years. The key effort will be to advance regulatory science and innovation, as noted above. Advancing regulatory science and innovation will make way for more regulatory activities, such as setting standards for products that address unmet public health needs and identifying and mitigating the spread of disease using informatics. The other four priorities focus on strengthening the safety and integrity of the global supply chain, strengthening compliance and enforcement activities to support public health, expanding efforts to the needs of special populations (including a focus on rare-disease therapies), and advancing medical countermeasures and emergency preparedness.

In terms of enforcement, Hamburg said in a message about the document that, “We must continue to build a stronger, more effective agency and, as this document outlines, do so in several specific ways. We will strengthen our collaborations with other public health agencies and leverage the expertise and resources of our colleagues at the international, federal, state, and local levels to ensure effective solutions for the American people. We will hold ourselves to the highest standards of transparency and accountability and give our partners and stakeholders insight into our processes and decision making.”

In the long term, FDA would like to improve overall public health by increasing the safety and effectiveness of drugs. The agency has a three-pronged plan for this goal: promote public health by ensuring the availability of safe and effective new drugs; protect public health by ensuring the quality and integrity of marketed drug products; and protect public health by promoting the safe use of marketed drugs. Other long-term objectives are to increase the nation’s preparedness to address threats of bioterrorism, as well as pandemic and emerging infectious diseases.

Other outlined goals in the five-year plan focus on tobacco regulation, prevention and control, and working toward organization excellence. FDA plans to implement the strategy through a tiered planning framework, integrating the priorities into annual budget proposals and planning. The agency’s Office of Regulatory Affairs will monitor progress toward achieving the stated objectives.

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