CBO: ADVERSE EVENT REPORTING BILL WILL COST GOVERNMENT $50 MILLION

The "Dietary Supplement and Nonprescription Drug Consumer Protection Act" will cost the federal government $3 million in 2007 and $50 million from 2007 to 2011 if it becomes law, the Congressional Budget Office (CBO) estimated Sept. 12.

The total annual cost to industry would be less than $2 million a year, the CBO said, citing data provided by the FDA. This cost would be borne by manufacturers, packers and distributors of nonprescription drugs and dietary supplements, who would be required to report to the FDA within 15 business days about any serious adverse events reported to them, and to maintain adverse event records for six years.

The cost to the government would be offset by increased revenue of $5 million between 2008 and 2016, mainly from fines for noncompliance.

The bill was introduced June 21 by Sen. Orrin Hatch (R-Utah) and passed the Senate Health, Education, Labor and Pensions Committee unanimously June 28. It defines a serious adverse event as anything resulting in death, hospitalization, disability or birth defect and directs the FDA to issue guidance to help the industry determine what qualifies under this definition.