Republican's bill to reform FDA, save jobs

Share this article:

Sen. Dan Coats (R-IN) has introduced a bill to clarify and reform FDA's mission in order to keep jobs from going overseas.

“The FDA Mission Reform Act would require the FDA to establish a predictable, consistent and transparent regulatory environment,” Coats said in a news release.

The measure's language calls for a regulatory system that:

• Advances medical innovation by incorporating modern tools, standards, and approaches to ensure the predictable and efficient review, clearance, approval and licensing of products;

• Protects the public health and enables patients to access novel products while promoting economic growth, innovation, competitiveness and job creation among the industries regulated by the FDA;

• Identifies and uses the most innovative and least burdensome tools for achieving regulatory ends; and

• Incorporates a patient-focused benefit-risk framework that accounts for varying degrees of risk tolerance.
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Headliner: Proteus CEO takes an original path

Headliner: Proteus CEO takes an original path

Andrew Thompson, CEO, Proteus Digital Health

Leadership Exchange: How Do We Get Beyond the Pill?

Leadership Exchange: How Do We Get Beyond the ...

As its focus moves from manufacturing to service, pharma needs to partner with healthcare neophytes as well as established players. James Chase asks six experts to assess the risks and ...

FDA and off-label uses: a balancing act

FDA and off-label uses: a balancing act

FDA's current re-examination of its off-label promotion policies in light of the First Amendment is a delicate balancing act between its rock-solid traditional enforcement posture and a diverse new electronic ...