Drug Promotion

Drug Promotion


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.

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