New bipartisan bill would give FDA the power to add off-label uses to generic drug labels

WASHINGTON — A bipartisan duo of senators wants to give the Food and Drug Administration the power to add off-label uses to certain generic drug labels.

Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) introduced legislation late Thursday that would put in place new requirements on generic drug makers and FDA.

Right now, drug makers can only market a drug for a new use — like treating a different condition or offering a different dosage — if they spend the time and money to submit a label change to the FDA. Generic drug makers, however, can’t launch that process. Only branded drug makers can.

STAT+ Exclusive Story

Already have an account? Log in

This article is exclusive to STAT+ subscribers

Unlock this article — plus daily intelligence on Capitol Hill and the life sciences industry — by subscribing to STAT+.

Already have an account? Log in

Individual plans

Group plans

Monthly

$39

Totals $468 per year

$39/month Get Started

Totals $468 per year

Starter

$20

for 3 months, then $399/year

$20 for 3 months Get Started

Then $399/year

Annual

$399

Save 15%

$399/year Get Started

Save 15%

11+ Users

Custom

Savings start at 25%!

Request A Quote Request A Quote

Savings start at 25%!

2-10 Users

$300

Annually per user

$300/year Get Started

$300 Annually per user

View All Plans

To read the rest of this story subscribe to STAT+.

Subscribe

Log In