Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic

Monograph Regulation of Weight Control Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) UseProducts for Over-The-Counter (OTC) Use

Joint Nonprescription Drugs Advisory Committee andJoint Nonprescription Drugs Advisory Committee andEndocrine and Metabolic Drugs Advisory CommitteeEndocrine and Metabolic Drugs Advisory CommitteeMeetingMeeting

Arlene Solbeck, M.S.Arlene Solbeck, M.S.Senior Regulatory Review ScientistSenior Regulatory Review ScientistDivision of Nonprescription Regulation DevelopmentDivision of Nonprescription Regulation Development

Center for Drug Evaluation and ResearchCenter for Drug Evaluation and Research

2Joint NDAC/EMDAC Meeting Joint NDAC/EMDAC Meeting January 23, 2005January 23, 2005

Overview

• What is an OTC monograph?

• What is the current status of the monograph for OTC weight control ingredients/products established in 1982?


OTC MonographsOTC Monographs

• OTC Drug Review initiated in 1972

• > 100,000 OTC drug products that contained > 700 active ingredients

• Active ingredients reviewed by therapeutic categories


OTC Monographs OTC Monographs

• Category I: GRASE (Generally Recognized as Safe and Effective)

• Category II: not GRASE• Category III: data insufficient to determine if safe

and effective; more data needed

Advisory Review Panel



• Category I: GRASE• Category II: not GRASE• Category III: cannot determine if safe and

effective ANPR



ANPRTFM

Comments



TFM

Comments

Data

FM


OTC MonographsOTC MonographsSummarySummary

• Regulatory pathway for marketing of GRAS/GRAE OTC ingredients and drug

products

– Public process

– Active ingredient specific

– Pre-approval not required


Weight Control Products For Over-The Weight Control Products For Over-The Counter UseCounter Use

Panel’s Report (ANPR)Panel’s Report (ANPR)

• January 26, 1982

• Advisory Review Panel on OTC Miscellaneous Internal Drug Products


Weight Control Drug Products – Definition and UseWeight Control Drug Products – Definition and Use

• Definition of weight control drug product (January 26, 1982)

– An agent which reduces appetite

• Indication statements

– Helps control appetite

– Helps curb appetite

– For appetite control to aid weight reduction

– An aid for effective appetite control to assist weight reduction

– Helps you eat less, weigh less

– Appetite depressant in the treatment of obesity (excess weight)

– An aid in the control of appetite

– An aid to diet control in conjunction with a physician’s recommended diet

– For use as an aid to diet control


Panel’s Definition of “Obesity”Panel’s Definition of “Obesity”

• Target population– Adult “obese” persons free of known underlying organic

diseases

• Panel’s definition of obesity (1982)

“An increase in body weight beyond the limitation of skeletal and physical requirements as the result of an excessive accumulation of fat in the body; that physical state in which body weight in relation to height and body build is more than 10 percent above the ideal weight determined from the Metropolitan Life Insurance Company table of desirable weights”


Duration of Use Duration of Use

• Duration of use

– Temporary (3 months)

– In conjunction with a diet

– 3 months enough time to establish new eating habits

– Labeling to state: “This product’s effectiveness is directly related to the degree to which you reduce your usual daily food intake. Attempts at weight reduction which involve the use of this product should be limited to periods not exceeding three months, because that should be enough time to establish new eating habits.”


Efficacy Criteria Efficacy Criteria

• Efficacy Studies

– 12 week treatment period

– Average weight loss:

PLACEBO TEST

1 lb / week12 lbs / treatment period

1.5 lbs / week18 lbs / treatment period


IngredientsIngredients• 113 reviewed

• 2 recommended for Category I– Phenyl propanolamine hydrochloride (PPA)

– Benzocaine

• 111 ingredients recommended for Categories II and III by Panel

• 111 ingredients classified as “not generally recognized as safe and effective” (nonmonograph) – TFM: 1990

– FM: 1991


Current Status of Category I IngredientsCurrent Status of Category I Ingredients

• Phenylpropanolamine hydrochloride (PPA): – FDA published a proposed rule to reclassify PPA from

Category I to Category II (nonmonograph) based on safety concerns (2005)

• Benzocaine: – Final rulemaking in progress that will address the

adequacy of available efficacy data for benzocaine for weight reduction


Panel’s Report - SummaryPanel’s Report - Summary• Panel’s recommendations:

– OTC weight control drug products reasonable

• for temporary use (3 months)

• for assistance in weight reduction

• in “obese” population

• in conjunction with a diet

• Panel recognized that a diet and other behavioral changes are integral

components of weight control

• Uncertain whether there will continue to be any active ingredients in the

weight control monograph recognized as safe and effective for that

intended use.

Documents

Monograph Regulation of Weight Control Products for Over-The-Counter (OTC) Use Joint Nonprescription Drugs Advisory Committee and Endocrine and Metabolic