Introduction - overview What is it? Goals of DTC Types of DTC Pros/Cons DTC’s role in the drug spending/prescribing Laws with DTC in U.S. DTC in other countries – NEW ZEALAND DTC in other countries - INDIA Future of DTC Use examples: commercials, magazines, online websites Lipitor yaz – the recall one garadisil websites with ads
The promotion of prescription drugs through newspaper, magazine, television and internet marketing. Provided by drug companies, these ads are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio, and published in magazines and newspapers. They also appear online.
Getting accurate information about disease and treatment options to patients & consumers. To make doctors and patients better partners by encouraging patients to visit their doctors and ask important questions pertaining to their health.
The FDA describes three types of DTC advertisements: Product Claim Advertisements Help-Seeking Advertisements Reminder Advertisements
Product Claim Advertisements: The most common of the three, these typically include both the brand name and the condition the drug treats. They also describe the risks and benefits associated with taking the medication. " Targets a specific prescription drug and must contain safety and efficacy information. Regulations require that these advertisements comply with adequate provision and fair-balance principles **Fair-balance rule: DTC advertisements must provide a fair balance between the benefits and risks of a drug.
Help-Seeking Advertisements: Also known as disease-awareness communications, these mention the disease or health condition but not the name of the drug that treats it. The purpose of this type of advertisement is to create an awareness of symptoms or conditions among consumers. (GAO, 2002) These advertisements are not required to provide risk information and are not regulated by the FDA. Encourages consumers with a particular set of symptoms to seek consultation with their physician and discuss treatment options. Does not mention a particular product. Forbidden if a product is the only available treatment for a specific condition, symptom, or disease.
Reminder Advertisements: This type of advertisement, which is exempt from risk disclosure requirements, names the drug and dosage form or cost information. It does not mention the condition it treats or make claims or representations about the product. Contains the name of the drug and very limited information; excludes all other claims about the product. Reinforces name and brand loyalty.
This is a page from Twitter . Each of the <140-character postings in the middle column is called a Tweet, purportedly written by American racecar driver Charlie Kimball , who “partners with Novo Nordisk to prove his high performance career is possible with diabetes”. This is what drug companies like Novo Nordisk call a “branded Tweet” and a “Direct to Consumer” (DTC) ad. All that very fine barely readable print on the left sidebar is about Novo Nordisk’s long-acting insulin called Levemir . The branded Tweet does not mention any benefits of Levemir because it’s a reminder ad, which is not required to include side effect information if it does not mention any benefits. Instead, this reminder ad for Levemir lets Charlie Kimball act as the schill for Novo Nordisk.
If patients are given faulty or misleading information, subsequently request a prescription, and are not denied the prescription by their physician (for a host of possible reasons), then it's possible that people will be getting the drug who don't need it, and the consequences of that run the gamut from wasteful (of resources) to contraindicated and life-threatening. That's a bad thing, obviously.
the pharmaceutical companies promise to hold off on consumer advertising of a new medicine until they spend an "appropriate" amount of time educating health care professionals about the medicine.
Omission of Risk Information - The FDA pointed out that by omitting risks associated with drugs promoted in the adverts, the adverts suggest that the named brands are safer than has been demonstrated Minimization of Risk Information Specifically, the advert text claimed that the drug has “Low Incidence of Side Effects “ . The FDA pointed out that “ the use of this claim, coupled with total omission of risk information, severely minimizes the risks of [the advertised drug] “. Inadequate communication of indication DA pointed out to one pharmaceutical company that their advert for a drug “ misleadingly broadens the indication of [the advertised drug] by implying that any patient with cancer who requires treatment for breakthrough pain is a candidate for [the drug's] therapy, when this is not the case. ” Overstatement of Efficacy The FDA warned “ By omitting this information, the link suggests that the drug can be used indefinitely, when this is not the case. ” Failure to use established brand names - All fourteen of the FDA’s letters warned of failure to use the full established names of the drug being promoted.
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OverviewWhat 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 Zealand IndiaFuture of DTC
What is Direct-to-ConsumerAdvertising?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 DTCAInform consumers about different diseasesInform consumers about different treatment optionsEncourages patients to visit their primary care physiciansMake doctors and patients better partners
History of DTCA1950s - early 1980s Pharmaceutical ads directed to medical personnel and absent from mass mediaFirst DTC television ad for Boots Pharmaceuticals’ Rufen (ibuprofen) aired in early 1980sAdvent of Merck and Dohme’s advertising campaign for Pneumovax, pneumonia vaccine Pharmaceutical companies recognized that doctor-patient relationships changed with the rise of consumer and patients’ rights movement
History of DTCA1983 – 1985 DTCA suspended so FDA could create a more explicit policy1997 FDA relaxed rules so that drug companies use drug’s brand name and describe benefits in the same ad Before 1997, drug companies can only use drug’s name but cannot disclose what it was intended to treat
Types of DTCAProduct ClaimHelp-seekingReminder
Product 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 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 AdvertisementsTalks about brand, dosage form, and cost informationDoes not include medical conditionDoes not make claims about the productReinforces brand name and brand loyalty
Pros of DTCAInforms consumers about new treatmentsMeets increasing demand for medical informationEncourages people to seek medical attention for conditions or symptoms that might otherwise go untreatedPatients are not ashamed of their diseases.Patients are more proactive in their personal health.
Meets increasing demand formedical information
Meets increasing demand formedical information
Cons 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 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.
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 FDAs Center for Drug Evaluation and Research (CDER) is responsible for implementing the regulations governing DTC advertising
FDA 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 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 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 ProgramFDAs 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 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 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 SubstanceConsumer Advertisements
Internet Issues With DTCAFDA sent out warning letters in March 2009 to 14 pharmaceutical companies about online advertisements that violated regulations Omission of risk information Minimization of risk information Inadequate communication of indication Overstatement of efficacy Failure to use established brand names
DTCA 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 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: 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 Zealanders by regulating medicines and medical devices to 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: MedsafeMedsafe regulates products used for a therapeutic purpose. They include: Medicines Related products Herbal remedies Medical devices Controlled drugs used as medicines
New 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 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 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 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 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 devices Laying down regulatory measures, amendments to Acts and Rules To regulate market authorization of new drugs
DTCA 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 IndiaThe Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 Control advertisements regarding drugs Prohibits advertising of remedies alleged to possess magic qualities Prohibits advertising of Rx drugs defined as Schedule H and Schedule X Drugs
DTCA 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 IndiaDefinition of a “magic remedy” inIndia:Includes talisman and any othercharms that possess powers intendedto be used for diagnosis, cure,mitigation, treatment or prevention ofany disease in human beings oranimals.
India: Drugs and Magic Remedy Act The 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 women the diagnosis, cure, mitigation, treatment or prevention of any venereal disease to 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 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 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 2009Under new rules, medical practitioners in India cannot accept any gifts or favors from drug companies. The new rule went into effect on December 10 th 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 2009 Pharmaceutical companies are allowed to publish in medical journals and send drug reps to offices and hospitals.
Future 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 DTCAIndustry : Be honest and accurate with customers. Price comparisons, detailed explanations of benefits and risks, and discussions of costs are encouraged Drug industry should realize responsible self regulation and self-policing Promotions provide just as much attention to side effects as they do to treatment effects Advertisements be less “drug-centric” and more “disease/medical condition–centric”
Future of DTCAMedical community: Respond vigorously to DTC advertising The 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 theFuture 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?
Sources Peter R Mansfield, Barbara Mintzes, Dee Richards and Les Toop Direct to consumer advertising. Off of Bmj.com http://www.commercialalert.org/news/archive/2005/09/new-zealand-to-ban-dt http://www.kff.org/rxdrugs/6084-index.cfm https://www.cia.gov/library/publications/the-world-factbook/geos/nz.html#top www.globalbusinessinsights.com/content/rbhc0031m.pdf Sandra, Coney: Direct-to-Consumer Advertising of Prescription Pharmaceuticals: A Consumer Perspective from New Zealand OECD Health Policy Studies: Pharmaceutical Pricing Policies in a Global Market. OECD 2008.