Statement of Administration Policy: H.R. 2454 - Generic Drug Enforcement Act of 1991

(House)
(Dingell (D) MI and 43 others)

The Administration does not object to House passage of H.R. 2454, but will seek amendments in the Senate to address various concerns with the bill, including:

—   The broad Inspector General authority. The bill would give the Inspector General of the Department of Health and Human Services (HHS) broad authority to investigate (1) violations of the Prescription Drug Marketing Act, and (2) other allegations of violations as requested by the FDA Commissioner and Secretary of HHS. This expanded authority is unnecessary and inappropriate, because FDA has moved aggressively to strengthen its enforcement capability. For example, FDA is in the process of hiring 100 new, full-time criminal investigators.

—   The mandatory debarment of corporations. Mandatory debarment of corporations would needlessly obviate FDA's discretion to mitigate any unintended effects debarment may have on the availability of drugs or to consider efforts made by companies toward rehabilitation. Debarment of firms should be permissive.

—   The overly stringent requirements before a debarment order. The requirements mandated by H.R. 2454 before a debarment order is issued are more stringent than is necessary to protect the due process rights of those already convicted for fraud-related activity. Requiring FDA to conduct a formal evidentiary hearing after a conviction has been obtained entails a lengthy process that would seem unnecessary after the defendant's illegal conduct has already been established by the conviction.