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Bill in US Senate would accelerate FDA approval process

By Pat Murphy
Dolan Newswires

A bill introduced in the Senate is aimed at accelerating the Food and Drug Administration’s approval process for new drugs and treatments needed by patients with serious or life-threatening diseases.

The Transforming the Regulatory Environment to Accelerate Access to Treatments Act would accelerate the FDA’s review and approval processes for medicines that treat an unmet medical need or significantly advance the standard of care. In addition, the FDA’s review processes would also be improved for “highly targeted therapies” that address the needs of those with serious medical conditions.

“This legislation creates a consistent process and a clear and effective pathway at [the] FDA that will encourage the development of innovative treatments for patients otherwise dependent on the uncertainty of medical breakthroughs,” Senator Kay Hagan, D-N.C., the bill’s sponsor, said in a press release.

According to the press release, the TREAT Act draws its inspiration from accelerated approval processes that helped HIV and cancer treatments advance in the 1990s.

“For patients suffering today from rare diseases for which there are no current treatments, medical advances can’t come fast enough,” Hagan said.

In addition to streamlining drug review and approval processes, the TREAT Act would enhance the FDA’s access to external scientific and medical expertise by affording the FDA commissioner more leeway in granting waivers when a leading expert has a potential conflict of interest. The TREAT Act also recommends that patient advocates and disease research organizations be included in FDA advisory committee reviews.

Hagan introduced her bill Feb. 15. The bill will be referred to the Senate Health, Education, Labor and Pensions Committee, of which Hagan is a member.

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