FDA releases details on latest action plan

ROCKVILLE, MD: Two weeks ago, the FDA publicly released the details of its new strategic action plan, "Protecting and Advancing America's Health: Responding to New Challenges and Opportunities."

ROCKVILLE, MD: Two weeks ago, the FDA publicly released the details of its new strategic action plan, "Protecting and Advancing America's Health: Responding to New Challenges and Opportunities."

The specifics came almost five months after Commissioner Mark McClellan publicly outlined the initiative by revealing its five main focus areas: efficient risk management, patient and consumer safety, better informed consumers, counter-terrorism, and a strong FDA.

Peter Pitts, head of external communications for the agency, said the newly released details would serve as "another tool to more forcibly explain" the FDA's mission to protect and advance America's health to the media.

In an internal FDA memo announcing the release of the plan in its entirety, the commissioner noted that "every center and office....has a different contribution" to implementing the strategy.

Pitts said that keeping consumers better informed would be an area of heavy concentration for the FDA's communications department. Pitts said he and his team plan to place much of their initial focus on the controversial area of direct-to-consumer (DTC) communications.

In recent years, DTC, which sees pharmaceutical firms marketing prescription drugs directly to consumers, has become a marketing staple for the pharma industry.

"One of the most important ways consumers get information is through DTC," explained Pitts, "but we want to find out more about its power.

"We want to challenge the healthcare community to use DTC to educate consumers," and not just as a powerful selling tool, Pitts added.

The FDA has plans to hold a public meeting in November to collect feedback on how consumers view DTC.

Regarding, the FDA's decision to announce the plan's broad objectives months before its detailed components, Pitts said, "You can't get specific until you get general."

When the five goals were originally announced in April, the commissioner said that everything FDA employees did needed to impact at least one of the objectives.

By knowing beforehand what the action plan was designed to accomplish, said Pitts, the

staff was able to "put their brain power together" to determine what steps were actually necessary.

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