Measure accelerates FDA approval process

A bill introduced in the U.S. 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 (TREAT) Act would speed up 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,” Sen. Kay Hagan, D-N.C., the bill’s sponsor, said in a press release.

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.

— Pat Murphy