Medical Device Link.

Originally Published PMPN October 2003

REGULATORY FOCUS

The agency launches a strategic action plan to address new challenges to the public health.

Kassandra Kania, Managing Editor

FDA recently announced its five-part strategic action plan, titled "Protecting and Advancing America's Health: A Strategic Action Plan for the 21st Century." The plan highlights some of the steps FDA is taking to protect the public health of the United States from "unprecedented challenges and threats."

Efficient, science-based risk management. The agency will use science-based efficient risk management in all of its regulatory activities so that its limited resources can provide the greatest health promotion and protection at the least cost to the public. The plan recognizes that FDA is dealing with new threats in the area of enforcement, including criminals who are targeting drugs, infant formula, and other FDA-regulated products.

The agency will approach efficient risk management using the most current biomedical, statistical, managerial, and economic science. To achieve quicker access to safe and effective new products and reduce public health risks without unnecessary costs, FDA will take the following steps:

• Employ principles and technologies that can reduce avoidable delays and cost in product approvals.
• Overhaul and update the way medical products are manufactured.
• Implement more-effective strategies for food imports and food safety.
• Implement an enforcement strategy that combines clear communications to industry backed up by effective civil and criminal enforcement.

Empowering consumers. The plan will enable consumers to make smarter decisions by giving them access to better information to weigh the benefits and risks of FDA-regulated products. The agency's efforts will include encouraging better guidance to patients on pharmacy labels, clearer guidance on communicating risk and benefit information in direct-to-consumer advertising, and new enforcement initiatives against dietary supplement manufacturers' health claims.

Improving patient and consumer safety. FDA will seek improvements in patient and consumer safety by reducing risks associated with FDA-regulated products. Too many Americans suffer from adverse events related to medical products, dietary supplements, and food. As a result, the agency is enhancing its postmarket monitoring, communication, and regulatory activities. It needs to improve its systems for reporting safety problems. This can be done by improving the quality and standardization of its adverse-event reports and by having direct and secure access to relevant electronic health information. Bar coding medications and new methods for communicating with health professionals to reduce adverse events will speed implementation of safer systems.

Protecting America from terrorism. FDA plans to strengthen its capability to identify, prepare for, and respond to terrorist threats and incidents. Its objective is to protect the safety and security of human drugs, biologics, medical devices, veterinary drugs, and other FDA-regulated products. Strategies include additional staff for food-safety field activities, greater import presence at our national borders, threat assessments, and additional money for food security research. FDA's medical product centers are also working harder to speed the availability of countermeasures to protect the public against biological, chemical, nuclear, and radiological agents of terrorism.

More-effective regulation through a stronger workforce. FDA will ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish its mission. The agency is taking steps to improve retention and training. It is seeking outside experts and collaborations to augment its capabilities. FDA will also provide a consolidated headquarters campus to improve operations for employees. The new campus in White Oak, MD, will house 1700 FDA staff by 2005.

Additional information about FDA's strategic plan can be found at www.fda.gov/oc/mcclellan/strategic.html.

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