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FDA reveals strategy for risk-based regulatory framework

By Michelle Yeomans+

09-Apr-2014
Last updated on 09-Apr-2014 at 16:41 GMT

The Food and Drug Administration and Federal Communications Commission have issued a report that reveals a proposed strategy for a risk-based regulatory framework for health information technology. 

The report, which was mandated by Congress in the Food and Drug Administration Safety and Innovation Act (FDASIA), proposes that no new or additional regulations are needed to implement this regulatory framework.

It proposes a de-regulatory approach for clinical decision support (CDS) technologies and states that the majority of these products would be considered to have “health management health IT functions,” which the FDA does not intend to actively regulate.

Instead, the federal agencies propose an approach that “relies on ONC-coordinated activities and private sector capabilities.” 

The report responds to the concerns expressed by the health IT industry regarding potential over regulation because of the overlapping jurisdictions of three federal agencies by establishing the roles of each agency in a risk-based regulatory framework.

FDA regulation and the industry

Back in July, the Administration forged a far-reaching agreement with the cosmetics industry that would have meant cosmetics would be supervised as closely as the rest of the industries it oversees. The agreement was to serve as the basis for legislation to grant the FDA the new authority.

Under that deal, the agency would have had the power to test ingredients, inspect manufacturing plants and compel companies to report any adverse reactions to chemicals.

But that agreement fell apart as some companies backed away in early fall.

By March this year, legislation proposed by two cosmetic industry associations was rejected by the Administration due to what it claims was 'bad faith negotiations'.

At the time, FDA Deputy Commissioner Michael R. Taylor addressed a letter to the presidents of the Personal Care Products Council and the Independent Cosmetics Manufacturers and Distributors, whereby he expressed his "profound disappointment" over a proposal for a cosmetics regulatory overhaul.

According to Taylor, the recent industry set of counterproposals will have pre-empted the states' ability "to protect their citizens from unsafe chemicals in cosmetics."

As it stands, the FDA lacks the same level of regulatory authority over cosmetics that it has over food, medical devices and drugs.

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