Noora AlaliOshba Alsuwaidi

Amanda HaPatricia Cucinotta

Marion PetrykCindy Tam

Maria Tatarsky

OverviewOverviewWhat is DTCA?Goals of DTCAHistory of DTCADifferent types of DTC AdvertisementsPros and ConsDTCA’s role in drug spending and prescribingLaws in the U.S.DTCA in other countries

New ZealandIndia

Future of DTC

What is Direct-to-Consumer What is Direct-to-Consumer Advertising?Advertising?Also known as DTCAPharmaceutical company’s promotion of prescription

drugsAimed at a general audience (consumers)Appear on TV and radio, in magazines and newspapers,

and also online

Goals of DTCAGoals of DTCAInform consumers about different diseasesInform consumers about different treatment optionsEncourages patients to visit their primary care physiciansMake doctors and patients better partners

History of DTCAHistory of DTCA1950s - early 1980s

Pharmaceutical ads directed to medical personnel and absent from mass media

First DTC television ad for Boots Pharmaceuticals’ Rufen (ibuprofen) aired in early 1980s

Advent of Merck and Dohme’s advertising campaign for Pneumovax, pneumonia vaccinePharmaceutical companies recognized that doctor-patient

relationships changed with the rise of consumer and patients’ rights movement

History of DTCAHistory of DTCA1983 – 1985

DTCA suspended so FDA could create a more explicit policy

1997FDA relaxed rules so that drug companies use drug’s

brand name and describe benefits in the same adBefore 1997, drug companies can only use drug’s

name but cannot disclose what it was intended to treat

Types of DTCATypes of DTCAProduct Claim

Help-seeking

Reminder

Product Claim AdvertisementsProduct Claim AdvertisementsMost common formIncludes brand name & medical conditionDescribe risks and benefitsMust contain safety & efficacy informationMust comply with fair-balance rulePaxil Product Claim Commercial

Help-Seeking AdvertisementsHelp-Seeking Advertisements• A.K.A. disease-awareness communications• Talks about disease or medical condition• Does not discuss name of drug• Creates awareness of health conditions among

consumers• No requirement for risk information• Encourages physician consultations• Vaccine Help-Seeking Commercial

Reminder AdvertisementsReminder AdvertisementsTalks about brand, dosage form, and cost

informationDoes not include medical conditionDoes not make claims about the productReinforces brand name and brand loyalty

Reminder AdvertisementsReminder Advertisements

Pros of DTCAPros of DTCAInforms consumers about new treatmentsMeets increasing demand for medical informationEncourages people to seek medical attention for

conditions or symptoms that might otherwise go untreated

Patients are not ashamed of their diseases. Patients are more proactive in their personal health.

Meets increasing demand for Meets increasing demand for medical informationmedical information

Meets increasing demand for Meets increasing demand for medical informationmedical information

Encourages people to seek Encourages people to seek medical attention medical attention

Cons of DTCACons of DTCAPatients may misunderstand ads and request a

prescription for an illness they may not havePatients start to self- diagnose and think they need

treatment when they don’t. Physicians can feel pressured to prescribe a particular

medication.

DTCA Role in CostsDTCA Role in CostsResearch and Development (R&D) costs and promotion

costs are rising.

DTC costs are barely changing.

R&D is still the main point of spending of pharmaceutical companies.

DTCA Role DTCA Role in Costsin CostsDoes not increase

spending

DTCA DTCA Role in Role in CostsCostsDoes not

increase spending

Who Regulates DTCA?Who Regulates DTCA?The FDA regulates the advertising of prescription drugs

under the Federal Food, Drug, and Cosmetic Act (FFDCA)

The Division of Drug, Marketing, Advertising, and Communications (DDMAC) within the FDA's Center for Drug Evaluation and Research (CDER) is responsible for implementing the regulations governing DTC advertising

FDA RegulationsFDA RegulationsSection 502(n) of the FFDCA requires that an

advertisement include "the established name, the brand

name (if any), the formula showing quantitatively each

ingredient, and information in brief summary which

discusses side effects, contraindications, and

effectiveness."

FDA RegulationsFDA RegulationsPrescription drug advertising regulations in the Code of

Federal Regulations, Title 21, part 202 (21 CFR part 202)

specify that prescription drug advertisements must not

be false or misleading,

must not omit material facts, and

must present a fair balance between effectiveness and

risk information.

FDA RegulationsFDA RegulationsIf the FDA identifies a violation of laws or regulations in a

DTC advertisement, the agency may issue a regulatory letter asking the drug company to take specific actions.Untitled letters address violations, such as overstating

the effectiveness of the drug.Warning letters target pharmaceutical companies that

engage in continued violations of the act or address companies engaged in serious violations that affect consumer safety or health.

FDA Educational ProgramFDA Educational Program

FDA's educational outreach program is designed to educate healthcare providers about the role they can play in helping the agency make sure that prescription drug advertising and promotion is truthful and not misleading.

The "Bad Ad" Program is administered by DDMAC

PhRMA RegulationsPhRMA RegulationsThe pharmaceutical industry attempts to self-regulate

through a 15-point code of conduct issued by its trade association, Pharmaceutical Research and Manufacturers of America (PhRMA)

Example:All such advertising should be "accurate and not

misleading, should make claims only when supported by substantial evidence, should reflect balance between risks and benefits, and should be consistent with FDA-approved labeling."

DEA Issues With DTCADEA Issues With DTCAU.S. Drug Enforcement Administration (DEA) is

concerned about the issues of direct to consumer

advertising of controlled substance products and the

promotion of such products to the medical community

and may be contrary to the public interest.

Schedule II Controlled Substance Schedule II Controlled Substance Consumer AdvertisementsConsumer Advertisements

Internet Issues With DTCAInternet Issues With DTCAFDA sent out warning letters in March 2009 to 14

pharmaceutical companies about online advertisements that violated regulationsOmission of risk informationMinimization of risk informationInadequate communication of indicationOverstatement of efficacyFailure to use established brand names

DTCA in New ZealandDTCA in New ZealandDTC was permitted in New Zealand under conditions set

by the Medicines Act (1981) and Medicines Regulations (1984).

The new type of advertising wasn’t used until late 1980’s, specifically 1989 when then SmithKline and French ran a two-page advertisement in a magazine promoting a Hepatitis B vaccine.

In the same year Edinburgh Pharmaceuticals advertised Ventolin.

None of these advertisements actually complied with the legislative requirements.

DTCA in New ZealandDTCA in New ZealandMerck Sharp and Dohme’s Proscar (finasteride), a

treatment for benign prostatic hypertrophy, was the first television aired DTC advertisement in New Zealand.

Doctors who may not receive details for drugs before the launch of advertising campaigns that generate consumer inquiries cause potential harm.Sets up a complex relationship with patients

New Zealand: MedsafeNew Zealand: MedsafeMedsafe is the New Zealand Medicines and Medical

Devices Safety Authority. It is a business unit of the Ministry of Health and is the authority responsible for the regulation of therapeutic products in New Zealand.

Mission: To enhance the health of New Zealandersby regulating medicines and medical devicesto maximize safety and benefit.

Medsafe is accountable to the Ministry of Health, and through the Ministry to the Minister of Health.

www.medsafe.govt.nz/

New Zealand: MedsafeNew Zealand: MedsafeMedsafe regulates products used for a therapeutic

purpose. They include:

MedicinesRelated productsHerbal remediesMedical devicesControlled drugs used as medicines

New Zealand: MedsafeNew Zealand: MedsafePre-marketing approval must be obtained for new

and changed medicines. New medicines cannot be marketed in New Zealand without the consent of the Minister of Health. Medicines to which changes have been made cannot be marketed without the consent of the Director-General of Health. Data that satisfactorily establish the quality, safety and efficacy of the product, for the purposes for which it is to be used, must be submitted for evaluation before consent can be granted.

New Zealand: DTCA ReviewNew Zealand: DTCA ReviewIn 1994 a review of the Medicines Act proposed that DTC

be banned, but the Ministry of Health was favoring industry self-regulation to “shift a degree of responsibility, and therefore, cost, to the industry to act as watchdogs” (MOH 1995).

DTCA came under fire once again in 200o by minister of health, Anette King, influenced by Pharmac stating that DTC advertising was increasing the countries drug bill because of self regulation. This was overturned by the MOH arguing that banning DTC would be a a violation of the New Zealand bill of rights act of 1990.

New Zealand: DTCA ReviewNew Zealand: DTCA ReviewIn 2006 Annette King the health minister of New

Zealand’s Ministry of Health said that on the advice of various consumer/physician groups she was going to ban DTCA.

One reason being Professor Toop’s report: stating that “drug advertisements can endanger rather than empower consumers by minimizing risk information and maximizing benefits” and “could contribute to increased or inappropriate drug consumption”.

The New Zealand cabinet overturned her decision.

New Zealand: DTCA in 2009New Zealand: DTCA in 2009A comparison between the United States and New

Zealand showed that despite differences in the process of regulation and the conditions and mechanisms through which DTC advertising came to be legal in the two countries, the resulting character and effects of the advertising were remarkably similar.

Advertisements in both contexts turned out to be misleading, unbalanced with regard to risks and benefits, make appeals to emotions, and focus on lifestyle problems over serious conditions.

DTCA in IndiaDTCA in IndiaMinistry of Health and Family Welfare (= U.S. FDA)

Central Drugs Standard Control Organization (= U.S. CDER)Laying down standards of drugs, cosmetics,

diagnostics and devicesLaying down regulatory measures, amendments to

Acts and Rules To regulate market authorization of new drugs

DTCA in IndiaDTCA in IndiaD&C Act of 1940

Schedule H: List of drugs which are to be sold by retail against the prescription of Registered Medical Practitioner and which shall be labeled with words “Schedule H Drug - Warning: to be sold by retail on the prescription of a Registered Medical Practitioner only.”

DTCA in IndiaDTCA in IndiaThe Drugs and Magic Remedies

(Objectionable Advertisement) Act, 1954Control advertisements regarding drugsProhibits advertising of remedies

alleged to possess magic qualitiesProhibits advertising of Rx drugs

defined as Schedule H and Schedule X Drugs

DTCA in IndiaDTCA in IndiaDefinition of a “drug” in India:A medicine with active ingredients for internal or

external use.Any molecules or substances used for diagnosis,

cure, mitigation, treatment or prevention of disease.Others, like food, that intended to affect the human

body or animals in any way. Any substances that aimed to be used as a

component for medicine.

DTCA in IndiaDTCA in IndiaDefinition of a “magic remedy” in India:Includes talisman and any other charms that possess powers intended to be used for diagnosis, cure, mitigation, treatment or prevention of any disease in human beings or animals.

India: Drugs and Magic Remedy ActIndia: Drugs and Magic Remedy ActThe Act prohibits the advertising of following:

the procurement of miscarriage in women or prevention of conception in women

the maintenance or improvement of the capacity of the human being for sexual pleasure

the correction of menstrual disorders in womenthe diagnosis, cure, mitigation, treatment or prevention of any

venereal diseaseto directly or indirectly give a false impression regarding the

true character of a drug or make false claim for it or to convey any false or misleading information in any material particular about it

India: Drugs and Magic Remedy ActIndia: Drugs and Magic Remedy Act This Act doesn’t prohibit the following ways of advertising:

any signboard or notice displayed by a registered medical practitioner including the treatment for any of the disease

any treaties or book dealing with any of the matters from a bonafide scientific standpoint

any advertisement related to any drug sent confidentially to any registered medical practitioners or to chemists for distribution among registered medical practitioners or to a hospital or laboratory

Government advertisements

DTCA in IndiaDTCA in India There is no law that directly says not to advertise drugs

that are not Schedule X or H (OTC Drugs) OTC drugs seen on TV ads in India:

Digestives, Antacids, Antiflatulents, Cold rubs and analgesic balms/creams, Vitamins/tonics/health supplements, Medicated skin treatment, Analgesic/cold tablets, Antiseptic creams/liquids, Glucose powders

India: DTCA in 2009India: DTCA in 2009Under new rules, medical practitioners in India cannot

accept any gifts or favors from drug companies. The new rule went into effect on December 10th 2009.It also bars doctors and their associates from endorsing

healthcare products or accepting research grants from the industry without official clearance from authorities.

A medical practitioner may participate in research projects funded by pharmaceutical and allied healthcare industries if the project is proper and ethical.

India: DTCA in 2009India: DTCA in 2009Pharmaceutical

companies are allowed to publish in medical journals and send drug reps to offices and hospitals.

Future of DTCAFuture of DTCAFDA:

Increase the likelihood of effective self-regulation through strong, well-funded, and aggressive oversight.

Should take the lead in providing accurate, unbiased information to consumers

Future of DTCAFuture of DTCAIndustry :

Be honest and accurate with customers. Price comparisons, detailed explanations of benefits and

risks, and discussions of costs are encouragedDrug industry should realize responsible self regulation and

self-policingPromotions provide just as much attention to side effects

as they do to treatment effectsAdvertisements be less “drug-centric” and more

“disease/medical condition–centric”

Future of DTCAFuture of DTCAMedical community:

Respond vigorously to DTC advertisingThe public health community needs to create mechanisms

for providing consumers with objective, independent information about available drug therapies

Medical community needs to develop a systematic, ongoing media literacy campaign to inform consumers of the promotional nature of DTC advertising

What Do You Think About the What Do You Think About the Future of DTCA?Future of DTCA?Will DTC spending increase or decrease in the next

decade?Should all or some forms of DTCA be banned in the U.S.?Should there be a moratorium on DTCA? Should it be

mandatory or voluntary?Should the business-tax deduction for DTC spending be

taken away by legislation?Is there adequate risk information presented in DTCA?

Should there be more? Less?Should there be more explicit guidelines with DTCA on

the internet?

Thank you for your time…Thank you for your time…

QUESTIONS?QUESTIONS?

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advertising/ http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/

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http://www.justice.gov/dea/pubs/cngrtest/ct121101.html

SourcesSourcesPeter R Mansfield, Barbara Mintzes, Dee Richards and Les Toop Direct to

consumer advertising. Off of Bmj.comhttp://www.commercialalert.org/news/archive/2005/09/new-zealand-to-

ban-dtc-advertising-by-06http://www.kff.org/rxdrugs/6084-index.cfmhttps://www.cia.gov/library/publications/the-world-factbook/geos/nz.htm

l#topwww.globalbusinessinsights.com/content/rbhc0031m.pdfSandra, Coney: Direct-to-Consumer Advertising of Prescription

Pharmaceuticals: A Consumer Perspective from New ZealandOECD Health Policy Studies: Pharmaceutical Pricing Policies in a Global

Market. OECD 2008.

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