NCJ Number
56814
Journal
FOOD, DRUG, AND COSMETIC LAW JOURNAL Volume: 33 Issue: 9 Dated: (SEPTEMBER 1978) Pages: 482-488
Date Published
1978
Length
7 pages
Annotation
CONSUMER PROTECTION LEGISLATION TO GRANT THE FOOD AND DRUG ADMINISTRATION POWER REGARDING CIVIL PENALTIES, SEIZURES AND INJUNCTIONS AGAINST DRUG PRODUCTS, AND DRUG MANUFACTURE LICENSE REVOCATION IS CRITICIZED
Abstract
IN THE PROPOSED LEGISLATION, KNOW AS THE DRUG REGULATION REFORM ACT, A $10,000 CIVIL PENALTY AGAINST INDIVIDUALS AND A $25,000 PENALTY AGAINST CORPORATIONS ARE STIPULATED. WITH THE FOOD AND DRUG ADMINISTRATION HAVING CIVIL PENALTY POWER, A FACTORY INSPECTION WITH FIVE ITEMS TO BE CORRECTED MAY BE ALTERED, FOR EXAMPLE, TO INCLUDE A $2,000 GOOD MANUFACTURING PRACTICES FINE, A COUPLE OF $1,000 FINES FOR RECORDS VIOLATIONS, AND A FEW $500 MINOR PENALTIES LISTED IN WHAT USED TO BE CALLED A REGULATORY LETTER OR INFORMATION LETTER. MORE ADMINISTRATION ATTORNEYS IN MORE CITIES, WITH MORE ADMINISTRATIVE LAW JUDGES AND PENALTY ASSESSMENT OFFICERS, WILL RESULT IN AN INCREASED NUMBER OF INSPECTION REPORTS NOTING MAJOR OR MINOR VIOLATIONS IN THE $100 TO $500 RANGE. THE CIVIL PENALTY PROVISION MAY ADVERSELY IMPACT THE DRUG INDUSTRY, BUT IT CAN BE ARGUED THAT THE ADMINISTRATION SHOULD HAVE THE SAME POWERS GIVEN BY CONGRESS TO THE OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION OR THE ENVIRONMENTAL PROTECTION AGENCY. ANOTHER AREA OF SIGNIFICANT INTEREST TO THE DRUG INDUSTRY IS THE IMPOSITION OF A FEDERAL EMBARGO AGAINST DRUG PRODUCTS OR COMPONENTS THAT GOODS ARE PROBABLY IN VIOLATION OF THE LEGISLATION AND CAN POTENTIALLY BE SEIZED. SEIZURES AND INJUNCTIONS UNDER AN EMBARGO ARE MORE NARROWLY DEFINED TO OVERCOME CASE LAW DEVELOPMENTS. A FINAL ASPECT OF THE PROPOSED LEGISLATION INVOLVES THE POWER OF THE ADMINISTRATION TO SUSPEND AND REVOKE MONOGRAPHS AND LICENSES IF IT FEELS THAT SUPPORT IS LACKING, IN RETROSPECT, FOR ONE OR MORE CLAIMS OR APPROVALS OF PRODUCTS. A LICENSE MAY BE SUSPENDED IMMEDIATELY IF THE ADMINISTRATION MAKES A FINDING OF UNREASONABLE AND SUBSTANTIAL RISK OF INJURY. A MONOGRAPH, HOWEVER, MUST BE SUSPENDED IF THE ADMINISTRATION DECIDES TO REVOKE A MONOGRAPH FOR A FIRM'S FAILURE TO FOLLOW REQUIREMENTS OF THE MONOGRAPH AS SET OUT IN ITS ORIGINAL TEXT. IT IS ARGUED THAT EVEN THOUGH THE DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE IS WILLING TO DIMINISH CRIMINAL LIABILITY, THE FDA'S PROPOSED LEGISLATION CONSTITUTES A DANGER TO THE ECONOMIC VIABILITY OF DRUG MARKETING. CASE LAW IS CITED. (DEP)