Food & Drug Bulletin

Dear Reader:

Four years ago there was great optimism about prospects for 1995 because both the House and Senate for the 104th Congress consisted of a Republican majority committed to reform. Since then, Congressional investigations and deliberations produced a significant legislative accomplishment through passage of the Food and Drug Administration Modernization Act (FDAMA) of 1997.

The FDA has made considerable progress to implement FDAMA and Congressional oversight has been cautious during the absence of a Senate confirmed Commissioner. On December 15, 1998, Jane E. Henney, M.D. was sworn in as the 14th Commissioner after a comprehensive inquiry by the Senate. There is good reason to be equally optimistic about the possibility for continued beneficial reform in 1999. Commissioner Henny has prior experience as an FDA employee and made numerous commitments during her Senate confirmation hearings. Representatives of Congress also have expressed their commitment to conscientious oversight.

The arrival of Dr. Henny and surrounding events provide industry with a major opportunity. But this opportunity must be coupled with a commitment by industry leadership to support diligent pursuit of continuing reforms and internal company efforts to assure regulatory compliance.

Cordially,

Larry R. Pilot

Chairman, Food and Drug Department

Articles In This Issue

Dr. Jane Henney Confirmed As FDA Commissioner FDA Issues Final Rule On Dissemination Of Information On Unapproved/New Uses For Marketed Drugs, Biologics, And Devices Federal Trade Commission Guidances Issued On Advertising Of Dietary Supplements And Food Products FDA Releases Prescription Medication Guide Final Rule FDA Releases Plan For Statutory Compliance FDA Expands Medical Device Industry Initiatives FDA Announces Consideration Of Proposed Rule On Electronic Reporting Of Postmarket Adverse Drug Reactions FDA Announces The Availability Of Device Postmarket Surveillance Guidances

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