US FDA ENFORCEMENT BILL DRAFT

A new discussion draft of the proposed US Food and Drug Administration enforcement legislation would provide the agency with powers of subpoena only in cases of civil penalty investigations.

Civil penalties may be assessed following hearings against anyone who submits false information to the FDA, withholds material information, bribes government employees or alters material documents. In the course of its investigation or hearing into such cases, "the FDA may issue subpoenas requiring the attendance and testimony of witnesses, and the production of evidence that relates to the matter under investigation," says the draft.

In the previous House bill, HR 3642, the agency's powers of subpoena were to be "freestanding," notes the Pink Sheet, adding that the new provision contained in the discussion draft is identical to that contained within the House debarment bill (HR 2454), and substantively the same as the provision in the 1990 medical device legislative amendments.