House Version of user Fee Legislation Gets Major Boost from CBO

Posted 30 May 2012 | By Alexander Gaffney, RAC 

What a difference a week and some amendments make. The Congressional Budget Office (CBO) has re-scored the House's amended version of the Food and Drug Administration Reform Act (FDARA) and has found that instead of costing taxpayers $250 million, it will now save taxpayers $370 million.

The distinction is important, and not just because of the fiscal implications for taxpayers. Under legislation commonly known as PAYGO, any normal legislation found to add to the deficit is required to find fiscal offsets elsewhere in the budget. As many programs have staunch defenders in Congress, this would open up the prospect of a heated legislative battle over issues unrelated to FDARA.

CBO said the fiscal savings in the newly-scored version of the bill have come from provisions to speed up the approval of generic pharmaceutical products. Such delays often cost federal programs money, as they as forced to expend resources on costly name-brand medications instead of their cheaper generic versions.

The savings now put FDARA roughly on par with the scoring of the Senate's user fee legislation. The Senate version of FDARA, known as the Food and Drug Administration Safety and Innovation Act (FDASIA), is estimated by CBO to save taxpayers $358 million over the coming decade.

Some of the savings from both bills come from a lag between when the government would receive payments from industry and when they would be expected to make required expenditures, but other portions are expected to save taxpayers money regardless. These include increased income as the result of fines from increased inspections and cheaper medicines available more quickly to federal programs thanks to quicker approval times for generic medicines.

FDARA is scheduled to come to a vote in the House of Representatives on 30 May.

Read more:

CBO - Amendment in the Nature of a Substitute to H.R. 5651, the Food and Drug Administration Reform Act of 2012

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles