Mary: THE FOOD AND DRUG ADMINISTRATION REVIEWS
ADVERTISING AND PROMOTIONAL LABELS FOR PRESCRIPTION DRUGS
TO MAKE SURE THE CONTENT ISN'T FALSE OR MISLEADING.
WHAT MATERIALS ARE REGULATED?
HOW CAN ADVERTISING VIOLATE THE LAW?
AND WHAT ARE THE CONSEQUENCES?
I'M CAPTAIN MARY KREMZNER AND THIS IS DRUG INFO ROUNDS,
BROUGHT TO YOU BY THE PHARMACISTS IN FDA'S
DIVISION OF DRUG INFORMATION.
Mary: I SPOKE WITH TWO FDA PHARMACISTS
LIEUTENANT COMMANDER BETH CARR AND COMMANDER JAEWON HONG
FOR TODAY'S DISCUSSION. 0
MARY: (to Beth) THERE ARE MANY ELEMENTS SURROUNDING
THE MARKETING AND ADVERTISING OF A DRUG PRODUCT.
LET'S START BY TALKING ABOUT WHICH
PROMOTIONAL MATERIALS THE FDA REGULATES.
Beth: SURE.
LET'S BEGIN BY MAKING A CLEAR DISTINCTION.
THE FEDERAL TRADE COMMISSION REGULATES ADVERTISING FOR
OVER-THE-COUNTER DRUG PRODUCTS.
FDA REGULATES ADVERTISING FOR PRESCRIPTION DRUGS,
WHICH IS OUR FOCUS TODAY.
FOR PRESCRIPTION DRUGS, THERE'S A RANGE OF MATERIALS
SUBJECT TO REGULATION, LIKE TV ADS, RADIO
AND JOURNAL ADS...BROCHURES...
EMAILS...
AND WEBSITES.
Jae: FDA OFTEN RECEIVES INQUIRIES ABOUT WHETHER OR NOT
PRESCRIPTION DRUG COMPANIES HAVE TO SUBMIT THEIR PROMOTIONAL
MATERIALS TO THE FDA BEFORE THEY APPEAR IN PUBLIC.
AND, IN MOST CASES FEDERAL LAW DOESN'T ALLOW THE FDA TO
REQUIRE AN ADVANCED REVIEW.
BUT MANUFACTURERS DO HAVE TO SUBMIT
ALL THEIR PROMOTIONAL MATERIAL AT THE TIME THEY GO PUBLIC.
MANY DRUG COMPANIES VOLUNTARILY SEEK OUT FDA
ADVICE BEFORE THEIR PROMOTIONAL MATERIALS ARE DISSEMINATED.
THEY WANT TO BE PROACTIVE IN ASSURING
THEIR PROMOTIONAL MATERIALS MEET FDA STANDARDS.
Mary: WHAT ARE SOME OF THE DIFFERENT WAYS THAT DRUG
COMPANIES VIOLATE THE FDA'S REGULATIONS?
Jae: FREQUENTLY CITED VIOLATIONS INCLUDE
OVERSTATING A DRUG'S EFFICACY...
AND OMITTING OR MINIMIZING INFORMATION ABOUT RISKS.
HERE'S A BOOK PUBLISHED BY A COMPANY CALLED
TARO PHARMACEUTICALS.
IT'S ABOUT OVIDE, THEIR LOTION FOR
THE TREATMENT OF HEAD LICE.
THE BOOK MAKES THE REPRESENTATION THAT OVIDE
IS INDICATED AND PRESCRIBED FOR THE TREATMENT OF HEAD LICE,
HOWEVER, NOWHERE DOES IT MENTION THE RISKS ASSOCIATED
WITH THE DRUG.
THIS IS A VIOLATION THAT MISLEADINGLY
SUGGESTS THAT OVIDE IS SAFER THAN HAS BEEN DEMONSTRATED.
Beth: OTHER COMMON AND FREQUENTLY CITED VIOLATIONS
INCLUDE UNSUBSTANTIATED SUPERIORITY CLAIMS,
AND UNSUBSTANTIATED CLAIMS OF EFFICACY OR SAFETY.
ALSO, IT IS IMPORTANT TO NOTE THAT ADS HAVE TO PRESENT RISK
AND EFFICACY INFORMATION IN A SIMILAR WAY,
WITH FONT SIZE, BULLETS, WHITE SPACE AND HEADLINES
THAT ALL MEET A "FAIR BALANCE" REQUIREMENT.
HERE'S ONE AD THAT RECEIVED AN UNTITLED LETTER FROM FDA.
AS YOU CAN SEE, THE AD PROMINENTLY PRESENTS
EFFICACY CLAIMS IN LARGE, BOLD,
AND COLORFUL FONT AND GRAPHICS,
WHILE THE RISK INFORMATION IS RELEGATED TO THE BOTTOM
OF THE PIECE AND IS WRITTEN IN AN EXTREMELY SMALL FONT
SIZE AND IN SINGLE-SPACED PARAGRAPH FORMAT.
Beth: ENFORCEMENT LETTERS SENT TO THE DRUG COMPANIES ARE THE
MOST FREQUENT AND COMMON TYPE OF ENFORCEMENT ACTION.
THESE LETTERS ARE POSTED ON THE FDA WEBSITE.
THE FDA REQUESTS THAT THE COMPANIES STOP
RUNNING THE AD IMMEDIATELY.
Jae: AND IF AN AD POSES A SERIOUS THREAT
TO PUBLIC HEALTH, THE FDA WILL ASK THE DRUG COMPANY TO STOP
RUNNING THE ERRONEOUS AD AND RUN A NEW,
CORRECTIVE ONE IN ITS PLACE, SIMILAR TO A RETRACTION YOU
MAY SEE FOR A NEWSPAPER ARTICLE.
Mary: FDA HAS ALSO ESTABLISHED THE BAD AD OUTREACH PROGRAM
TO EDUCATE HEALTHCARE PROFESSIONALS ABOUT THEIR ROLE
IN STOPPING DECEPTIVE OR MISLEADING DRUG PROMOTIONS.
IF YOU WANT TO LEARN MORE ABOUT WHAT YOU CAN DO
IF YOU SUSPECT A VIOLATION IN DRUG ADVERTISING,
PLEASE VISIT OUR WEBSITE.