A 'Phantom Recall' Does Not Comport with FDA's Regulatory Practice - Or Does It?: The Need for More Stringent Mandatory Reporting in FDA Matters

• Author: Eleanor G. Tennyson
• Position: J.D., The University of Iowa College of Law, 2012
• Pages: 1839-1863

1839

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

 J.D., The University of Iowa College of Law, 2012; M.S., Clemson University, 2009;

B.A., Grinnell College, 2007. I would like to thank the student writers and editors of Volumes

96 and 97 of the Iowa Law Review for their work on this Note—notably Andrew Tran and

Anthony Tucci. I would also like to thank my family—MTR, GET, AGT and GTT—as well as

SEP for constant encouragement and support.

1840 IOWA LAW REVIEW [Vol. 97:1839

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