Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T00-13 Print Media: 301-827-6242
March 8, 2000
Consumer Inquiries: 888-INFO-FDA
The record number of product recalls and detentions reflected in part the high priority Commissioner of Food and Drugs Jane E. Henney, M.D., places on ensuring the safety of products used everyday by American consumers and patients.
High standards for blood and blood products, which are regulated by FDA's Center for Biologics Evaluation and Research, are particularly important for public health. As such, they are protected by a system of overlapping safeguards. Although their violation does not necessarily mean that the involved blood product presents a health hazard, FDA takes protective action whenever the potential risk is increased. Last year, non- compliant blood and blood products accounted for nearly one-third (1,295) of the total 3,736 recalls.
The second highest number of recalls (1,263) included medical devices regulated by FDA's Center for Devices and Radiologic Health (CDRH). The FY 1999 total of product recalls was almost 30% above the average over the past 10 years.
Detentions of food and medical devices also accounted for the great majority of the 41,474 import shipments of violative and unsafe products that FDA prevented in FY 1999 from reaching American consumers. Almost one-half (19,283) of these shipments contained fresh produce and other food regulated by FDA's Center for Food Safety and Applied Nutrition (CFSAN). CDRH-regulated products accounted for nearly one-third (13,353) of the total.
In addition to recalls and detentions, ORA's nation-wide staff of 1,002 consumer safety officers and investigators conducted 15,161 inspections of facilities producing, warehousing, or distributing food and health care products. Based on these inspections, ORA issued 7,303 lists of observations noting noncompliance with public health regulations and 900 warning letters, and initiated 25 seizures and eight injunctions.
One FDA injunction, based on repeated findings of non-compliance in such critical areas as process validation and production and process control, resulted in a consent degree in which a firm agreed to stop manufacturing and distributing many of its products until it corrects its manufacturing problems. The firm also agreed to pay $100 million to the U.S. Treasury, the highest sum ever paid by an FDA-regulated company for a civil violation of public health laws.
Investigators from FDA's OCI last fiscal year arrested 373 suspected violators of public health laws and won 211 court convictions, the highest totals since the office was created seven years ago. Several criminal convictions resulting from OCI's investigations included heavy fines and lengthy incarcerations.
The most prominent of these cases involved massive marketing of Protropin. This synthetic human growth hormone had been approved by FDA on condition that its sponsor conduct a post-marketing study of 300 children who failed to reach the minimum height appropriate for their age. In spite of this agreement, the sponsor aggressively promoted the pediatric drug for unapproved medical conditions, and manipulated internal documents to conceal illegal practices that boosted the sales of Protropin to more than $1 billion. Last May, the sentencing resulted in the payment of a $30 million criminal fine and $20 million in restitution, the largest FDA criminal penalty against a pharmaceutical company.
FDA's enforcement activities complement the agency's premarket approval procedures, which are designed to bring safe and effective products to market promptly. By its vigorous enforcement of public health laws, FDA protects consumers against unsafe and ineffective products and sustains a level field for fair competition for the regulated industry.
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Office of Public Affairs
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