Expert: FDA strategy document lacking in detail

The FDA's strategic priorities document released last week shows the agency approaching its regulatory function more like a business than a government agency. "It's a good document," says Jim Prutow, a partner in consultancy PRTM's healthcare practice.

But he adds in a phone interview that he finds the document lacking in detail, especially when it comes to measuring results. "That area is light overall," he says. "We now need the business-plan level of granularity behind the strategy."

For example, the description of its transparency effort could have contained more information on the task force--especially details of what it will do to improve transparency.

Likewise with the priority of keeping up with science. Prutow says he's glad to see an emphasis on sound science in the priorities. "Over the past 10 to 20 years, it's been a struggle for the FDA to keep up," he says. But, "how will the FDA hire the expertise to get the job done?"

Hiring-of-expertise details also are needed for the global supply chain priority. "Current enforcement tools do not reflect today's commercial practices," the document says in its 10-item list of challenges in this massive effort. Prutow asks how the agency will use information technology to track and monitor products entering the U.S. and how it will collaborate with other countries.

- here's the FDA document

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