A “Phantom Recall” Does Not Comport with FDA’s Regulatory Practice—Or Does It?: The Need for More Stringent Mandatory Reporting in FDA Matters Eleanor G. Tennyson

ABSTRACT: This Note examines the regulatory and enforcement authority of the Food
and Drug Administration (“FDA”) in light of the recent rash of recalls of pediatric
over-the-counter medicines by The McNeil Consumer Healthcare Company (“McNeil”),
a subsidiary of Johnson & Johnson. After detailing the controversy surrounding
McNeil’s quality-control and recall procedures, the analysis focuses on proposed
legislation that would give the FDA mandatory recall authority. The analysis proposes
that, without requiring mandatory reporting of unexpected events associated with
drugs, such legislation may only equip the FDA with phantom authority. As such, it
concludes with a proposed methodology of co-reporting that would ensure the FDA has
both the knowledge and power necessary to force drug manufacturers and distributors
to comply with the FDA’s regulations.
I. INTRODUCTION .................................................................................... 1841
II. THE FDA’S RECALL POWERS AND THE MCNEIL “PHANTOM RECALL”
CONTROVERSY ...................................................................................... 1842
A. VOLUNTARY AND INVOLUNTARY RECALLS THE (IN)ABILITY OF THE
FDA TO MANDATE RECALL OF PHARMACEUTICAL AGENTS .............. 1843
B. THE HEADACHES OF TYLENOL AND MOTRIN: MCNEIL’S TWO-YEAR
BATTLE WITH SYSTEMIC RECALLS ................................................... 1845
C. A CONGRESSIONAL HEARING DISCOVERS LAPSES IN QUALITY
CONTROL AND DISTURBING REMEDIAL MEASURES UNDERTAKEN BY
MCNEIL ......................................................................................... 1848
D. THE HEADACHE CONTINUES: A SECOND CONGRESSIONAL HEARING
DETERMINED TO FULLY INVESTIGATE THE “PHANTOM RECALL” ...... 1849

III. USING THE “PHANTOM RECALL” TO ARM THE FDA WITH MORE
TANGIBLE ENFORCEMENT POWERS ...................................................... 1852
A. WHY DOESN’T THE FDA HAVE THE AUTHORITY TO MANDATE A
RECALL FOR DRUGS IN VIOLATION OF THE FDCA? ........................... 1852
B. AN ATTEMPT TO GIVE THE FDA MANDATORY RECALL POWER:
H.R. 5740 AND S. 1584 ................................................................ 1853
C. DOES THE PROPOSED LEGISLATION GIVE THE FDA PHANTOM
AUTHORITY? .................................................................................. 1856
D. ENSURING PROPER NOTICE BEGINS WITH MANDATORY FDA
NOTIFICATION................................................................................ 1858
1. Reporting Unexpected Drug Events to the FDA: The
Who, Where, How, and Why ............................................... 1859
2. The FDA Should Be Notified of All Unexpected Events
Related to Drugs and Medical Devices ............................... 1860
IV. CONCLUSION ....................................................................................... 1862

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