There are ethical and regulatory concerns regarding DTCA, specifically the extent to which these ads may unduly influence the prescribing of the prescriptions based on consumer demands when, in some cases, they may not be medically necessary, or there are cheaper options available. Critics of DTCA have argued that too much is spent on marketing medications, rather than into research and development; in the United States, ad spending by drugmakers reached US $5.2 billion in 2016. Types The U.S. Food and Drug Administration (FDA) defines several common types of DTCA for prescription medication. It classifies a "product claim" advertisement as one that identifies the scientific name and trademark brand name of the medication, and contains at least one approved indication for the drug, and claims surrounding its benefits. A "reminder" advertisement serves primarily to build brand recognition rather than promote the drug's uses and benefits. A reminder ad cannot contain any information or imagery that pertains to the drug itself, including benefits or how it functions, but may still contain a call to action urging viewers to ask their doctor or seek an external resource for more information. Reminder ads may include themes that vaguely allude to the drug's purpose: for example, a reminder commercial for the erectile dysfunction drug Viagra featured the showtune "Good Morning" and scenes of a man happily walking to work, emphasizing a sexual innuendo in the lyric "it's great to stay up late". A "help-seeking" advertisement is not presented as marketing for a drug first and foremost, and instead resemble an awareness campaign for a specific medical condition. They do not specify any specific product or treatment, and direct the audience to ask their doctor or seek an external resource (such as a website or phone hotline) for more information. These outlets are, in turn, used to promote specific prescription options. Awareness campaigns of this nature are sometimes used as preliminary marketing for new drugs. Reminder and help-seeking ads are often used by drugmakers to bypass the more onerous restrictions (such as the required listing of side effects), or outright prohibitions on product claims advertising, as neither of them are focused on promoting the drug itself. Sometimes, a campaign may mix both of these ads, with one ad discussing the condition, and another, similarly-styled ad, mentioning the product but not the condition, seeking to have the viewer infer the association between the ads. Legality Brazil In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals. Canada The Food and Drugs Act prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when Health Canada began to allow ads containing names, quantities, and prices only, so that pharmacies could display their prices for comparison purposes. In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited. Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad. There is no regulation requiring direct-to-consumer ads illegal under Canadian law to be removed or substituted when U.S. television channels and print publications are distributed within Canada. In 2014, York University professor and physician Dr. Joel Lexchin, and University of British Columbia associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations "[lacked] accountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement". Europe In October 2002, the European Commission voted against a proposal to selectively allow advertising of "disease education information" in relation to AIDS, asthma, and diabetes. Despite insistence otherwise due to its selective and controlled nature, the European Parliament Committee on the Environment, Public Health and Food Safety assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information. UK Labour Party MEP Catherine Stihler argued that the proposal was a "slippery slope" towards U.S.-style advertising practices promoting expensive "wonder drugs", and that "we don't want consumers sitting on their couches bombarded with a hard sell from big drug companies in the advertising break between Crossroads and Coronation Street." Hong Kong Under the Undesirable Medical Advertisements Ordinance, advertising of medications is only legal for "minor" diseases, such as coughs and colds, headaches, indigestion, and others. Ads may not include depictions of treatment, medical professionals, or dramatizations of symptoms. New Zealand Under the Medicines Act of 1981, and regulated by the Therapeutic Products Advertising Code and a self-regulatory code by the industry group Medicines New Zealand, New Zealand is one of the only countries beside the United States to allow direct-to-consumer advertising of prescription medications. An ongoing review of the Act to develop a replacement, the Therapeutic Products Bill, has faced lobbying efforts for and against the continued legality of DTCA. United Kingdom Advertising materials directed towards the general public are prohibited from containing any references to prescription-only medications, under the basis that they are not be presented as a consumer's choice. The home page of a drug manufacturer's website also constitutes advertising material, and thus may not include references to prescription products either. In a 2005 Health Select Committee hearing, GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept. United States Under the regulations of the Food and Drug Administration (FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major side effects and contraindications in the main body, with a "fair balance" in its coverage of benefits to risks. Unless they are given "adequate provision" via a variety of different outlets, ads must also include a "brief summary" of all risks associated with the medication. In print ads within magazines, this summary is typically given on a second page. Print ads must contain a standard notice that instructs patients to report negative side effects to the FDA's MedWatch program. In ads carried on broadcast media, such as television commercials, only the major side effects are typically listed, and the ad contains blurbs directing viewers to where they can obtain more information (the aforementioned "brief summary"), such as on a website, phone hotline, or a current magazine issue. If the drug is subject to a boxed warning from the FDA (which indicates a serious risk), the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited. Ads that do not make health claims do not fall under the FDA's jurisdiction, but can still be regulated by the Federal Trade Commission. Early history In 1962, the United States Congress gave the FDA the authority to regulate prescription drug labeling and advertising, but the FDA did not establish regulations until 1969. These required that ads for prescriptions include information on their major side effects and contraindications, and unless they have "adequate provision" via different outlets, a "brief summary" of all side effects and contraindications. Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine. However, a larger movement towards autonomy in health care decisions prompted the first prominent examples of direct-to-consumer advertising. Merck published the first print DTC ad for a pneumonia vaccine (with a particular focus on those aged 65 years or older), and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen. The advertisement promoted it as a cheaper alternative to the leading brand Motrin, and did not contain health claims. The FDA briefly demanded that the Rufen ad be pulled, but it was restored after minor amendments. As its guidelines were not written with mass media in mind, these early campaigns prompted concern from the FDA, especially after the arthritis drug Oraflex (whose release had been backed by a significant PR campaign) was recalled after only five months on the market, following reports of adverse reactions and deaths. FDA commissioner Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations. The moratorium was lifted in 1985. The industry felt that the requirement for a "brief summary" of all side effects was designed with print media in mind, and that their increasing length and technical language (often taking up an entire separate page of fine print when published in a magazine) made television advertising of prescriptions unfeasible. By the 1990s, there were calls for the FDA to loosen its regulations to make the concept viable. Partial deregulation A 1996 marketing campaign for then-prescription allergy medication Claritin found a loophole, by intentionally excluding information about the medication itself from its advertising. Clartin's television commercial contained only imagery, slogans such as "It's time for Claritin" and "Clear days and nights are here", and instructions to ask a doctor or call a phone number to request more information. In 1997, the FDA issued new guidelines that intended to make DTCM on radio and television less burdensome. In particular, the FDA clarified that informing the audience of where the "brief summary" can be obtained (such as a magazine ad, phone hotline, or website) constituted "adequate provision" of risk information, and thus relieved them from being included in the ad. The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not make any claims or statements regarding the indications and benefits of the medication. The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $ 1.12 billion. Despite this growth, there were concerns that some ads had an insufficient focus on properly discussing the product, while concerns were also shown for the advertising of erectile dysfunction medications during programming that may be widely watched by children. In 2005, Pharmaceutical Research and Manufacturers of America (PhRMA) instituted new voluntary guidelines for DTCA, including requirements to voluntarily submit ads to the FDA for review and educate health professionals on new medications before an advertising campaign commences, use clear language in advertising, obtain appropriate age targeting for advertisements involving subject matter that may be inappropriate to certain audiences, and to not use "reminder" ads. By 2011, spending on pharmaceutical advertising had grown to approximately US$4.5 billion per year, and increased to $5.2 billion by 2016. Proposed display of list prices On May 8, 2019, the Department of Health and Human Services (HHS) approved a mandate for list prices to be displayed in advertising for any prescription that costs $35 or higher for 30 days of treatment. Ads could also include price comparisons against competitors. PhRMA objected to the rule, arguing that prominent display of list prices would cause confusion because they do not reflect what patients would typically pay under insurance coverage (the rule did require display of a disclaimer stating that those with health insurance may pay a different amount). When the rule was proposed in October 2018, PhRMA stated that its members would commit to publishing detailed pricing information online (including possible out-of-pocket costs, and information on financial support options), and directing viewers to this information within their advertising. However, the HHS disputed their arguments, arguing that list prices would help patients calculate how much they would pay, especially if they have not yet met their insurance deductible, or the drug is not covered by their insurance. Secretary of Health and Human Services Alex Azar compared the proposed requirement to similar regulations involving list prices for automobiles.
There are ethical and regulatory concerns regarding DTCA, specifically the extent to which these ads may unduly influence the prescribing of the prescriptions based on consumer demands when, in some cases, they may not be medically necessary, or there are cheaper options available. Critics of DTCA have argued that too much is spent on marketing medications, rather than into research and development; in the United States, ad spending by drugmakers reached US $5.2 billion in 2016. Types The U.S. Food and Drug Administration (FDA) defines several common types of DTCA for prescription medication. It classifies a "product claim" advertisement as one that identifies the scientific name and trademark brand name of the medication, and contains at least one approved indication for the drug, and claims surrounding its benefits. A "reminder" advertisement serves primarily to build brand recognition rather than promote the drug's uses and benefits. A reminder ad cannot contain any information or imagery that pertains to the drug itself, including benefits or how it functions, but may still contain a call to action urging viewers to ask their doctor or seek an external resource for more information. Reminder ads may include themes that vaguely allude to the drug's purpose: for example, a reminder commercial for the erectile dysfunction drug Viagra featured the showtune "Good Morning" and scenes of a man happily walking to work, emphasizing a sexual innuendo in the lyric "it's great to stay up late". A "help-seeking" advertisement is not presented as marketing for a drug first and foremost, and instead resemble an awareness campaign for a specific medical condition. They do not specify any specific product or treatment, and direct the audience to ask their doctor or seek an external resource (such as a website or phone hotline) for more information. These outlets are, in turn, used to promote specific prescription options. Awareness campaigns of this nature are sometimes used as preliminary marketing for new drugs. Reminder and help-seeking ads are often used by drugmakers to bypass the more onerous restrictions (such as the required listing of side effects), or outright prohibitions on product claims advertising, as neither of them are focused on promoting the drug itself. Sometimes, a campaign may mix both of these ads, with one ad discussing the condition, and another, similarly-styled ad, mentioning the product but not the condition, seeking to have the viewer infer the association between the ads. Legality Brazil In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals. Canada The Food and Drugs Act prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when Health Canada began to allow ads containing names, quantities, and prices only, so that pharmacies could display their prices for comparison purposes. In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited. Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad. There is no regulation requiring direct-to-consumer ads illegal under Canadian law to be removed or substituted when U.S. television channels and print publications are distributed within Canada. In 2014, York University professor and physician Dr. Joel Lexchin, and University of British Columbia associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations "[lacked] accountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement". Europe In October 2002, the European Commission voted against a proposal to selectively allow advertising of "disease education information" in relation to AIDS, asthma, and diabetes. Despite insistence otherwise due to its selective and controlled nature, the European Parliament Committee on the Environment, Public Health and Food Safety assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information. UK Labour Party MEP Catherine Stihler argued that the proposal was a "slippery slope" towards U.S.-style advertising practices promoting expensive "wonder drugs", and that "we don't want consumers sitting on their couches bombarded with a hard sell from big drug companies in the advertising break between Crossroads and Coronation Street." Hong Kong Under the Undesirable Medical Advertisements Ordinance, advertising of medications is only legal for "minor" diseases, such as coughs and colds, headaches, indigestion, and others. Ads may not include depictions of treatment, medical professionals, or dramatizations of symptoms. New Zealand Under the Medicines Act of 1981, and regulated by the Therapeutic Products Advertising Code and a self-regulatory code by the industry group Medicines New Zealand, New Zealand is one of the only countries beside the United States to allow direct-to-consumer advertising of prescription medications. An ongoing review of the Act to develop a replacement, the Therapeutic Products Bill, has faced lobbying efforts for and against the continued legality of DTCA. United Kingdom Advertising materials directed towards the general public are prohibited from containing any references to prescription-only medications, under the basis that they are not be presented as a consumer's choice. The home page of a drug manufacturer's website also constitutes advertising material, and thus may not include references to prescription products either. In a 2005 Health Select Committee hearing, GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept. United States Under the regulations of the Food and Drug Administration (FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major side effects and contraindications in the main body, with a "fair balance" in its coverage of benefits to risks. Unless they are given "adequate provision" via a variety of different outlets, ads must also include a "brief summary" of all risks associated with the medication. In print ads within magazines, this summary is typically given on a second page. Print ads must contain a standard notice that instructs patients to report negative side effects to the FDA's MedWatch program. In ads carried on broadcast media, such as television commercials, only the major side effects are typically listed, and the ad contains blurbs directing viewers to where they can obtain more information (the aforementioned "brief summary"), such as on a website, phone hotline, or a current magazine issue. If the drug is subject to a boxed warning from the FDA (which indicates a serious risk), the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited. Ads that do not make health claims do not fall under the FDA's jurisdiction, but can still be regulated by the Federal Trade Commission. Early history In 1962, the United States Congress gave the FDA the authority to regulate prescription drug labeling and advertising, but the FDA did not establish regulations until 1969. These required that ads for prescriptions include information on their major side effects and contraindications, and unless they have "adequate provision" via different outlets, a "brief summary" of all side effects and contraindications. Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine. However, a larger movement towards autonomy in health care decisions prompted the first prominent examples of direct-to-consumer advertising. Merck published the first print DTC ad for a pneumonia vaccine (with a particular focus on those aged 65 years or older), and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen. The advertisement promoted it as a cheaper alternative to the leading brand Motrin, and did not contain health claims. The FDA briefly demanded that the Rufen ad be pulled, but it was restored after minor amendments. As its guidelines were not written with mass media in mind, these early campaigns prompted concern from the FDA, especially after the arthritis drug Oraflex (whose release had been backed by a significant PR campaign) was recalled after only five months on the market, following reports of adverse reactions and deaths. FDA commissioner Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations. The moratorium was lifted in 1985. The industry felt that the requirement for a "brief summary" of all side effects was designed with print media in mind, and that their increasing length and technical language (often taking up an entire separate page of fine print when published in a magazine) made television advertising of prescriptions unfeasible. By the 1990s, there were calls for the FDA to loosen its regulations to make the concept viable. Partial deregulation A 1996 marketing campaign for then-prescription allergy medication Claritin found a loophole, by intentionally excluding information about the medication itself from its advertising. Clartin's television commercial contained only imagery, slogans such as "Clear days and nights are here" and "It's time for Claritin", and instructions to ask a doctor or call a phone number to request more information. In 1997, the FDA issued new guidelines that intended to make DTCM on radio and television less burdensome. In particular, the FDA clarified that informing the audience of where the "brief summary" can be obtained (such as a magazine ad, phone hotline, or website) constituted "adequate provision" of risk information, and thus relieved them from being included in the ad. The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not make any claims or statements regarding the indications and benefits of the medication. The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $ 1.12 billion. Despite this growth, there were concerns that some ads had an insufficient focus on properly discussing the product, while concerns were also shown for the advertising of erectile dysfunction medications during programming that may be widely watched by children. In 2005, Pharmaceutical Research and Manufacturers of America (PhRMA) instituted new voluntary guidelines for DTCA, including requirements to voluntarily submit ads to the FDA for review and educate health professionals on new medications before an advertising campaign commences, use clear language in advertising, obtain appropriate age targeting for advertisements involving subject matter that may be inappropriate to certain audiences, and to not use "reminder" ads. By 2011, spending on pharmaceutical advertising had grown to approximately US$4.5 billion per year, and increased to $5.2 billion by 2016. Proposed display of list prices On May 8, 2019, the Department of Health and Human Services (HHS) approved a mandate for list prices to be displayed in advertising for any prescription that costs $35 or higher for 30 days of treatment. Ads could also include price comparisons against competitors. PhRMA objected to the rule, arguing that prominent display of list prices would cause confusion because they do not reflect what patients would typically pay under insurance coverage (the rule did require display of a disclaimer stating that those with health insurance may pay a different amount). When the rule was proposed in October 2018, PhRMA stated that its members would commit to publishing detailed pricing information online (including possible out-of-pocket costs, and information on financial support options), and directing viewers to this information within their advertising. However, the HHS disputed their arguments, arguing that list prices would help patients calculate how much they would pay, especially if they have not yet met their insurance deductible, or the drug is not covered by their insurance. Secretary of Health and Human Services Alex Azar compared the proposed requirement to similar regulations involving list prices for automobiles.
R
$5.2 billion in 2016. Types The U.S. Food and Drug Administration (FDA) defines several common types of DTCA for prescription medication. It classifies a "product claim" advertisement as one that identifies the scientific name and trademark brand name of the medication, and contains at least one approved indication for the drug, and claims surrounding its benefits. A "reminder" advertisement serves primarily to build brand recognition rather than promote the drug's uses and benefits. A reminder ad cannot contain any information or imagery that pertains to the drug itself, including benefits or how it functions, but may still contain a call to action urging viewers to ask their doctor or seek an external resource for more information. Reminder ads may include themes that vaguely allude to the drug's purpose: for example, a reminder commercial for the erectile dysfunction drug Viagra featured the showtune "Good Morning" and scenes of a man happily walking to work, emphasizing a sexual innuendo in the lyric "it's great to stay up late". A "help-seeking" advertisement is not presented as marketing for a drug first and foremost, and instead resemble an awareness campaign for a specific medical condition. They do not specify any specific product or treatment, and direct the audience to ask their doctor or seek an external resource (such as a website or phone hotline) for more information. These outlets are, in turn, used to promote specific prescription options. Awareness campaigns of this nature are sometimes used as preliminary marketing for new drugs. Reminder and help-seeking ads are often used by drugmakers to bypass the more onerous restrictions (such as the required listing of side effects), or outright prohibitions on product claims advertising, as neither of them are focused on promoting the drug itself. Sometimes, a campaign may mix both of these ads, with one ad discussing the condition, and another, similarly-styled ad, mentioning the product but not the condition, seeking to have the viewer infer the association between the ads. Legality Brazil In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals. Canada The Food and Drugs Act prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when Health Canada began to allow ads containing names, quantities, and prices only, so that pharmacies could display their prices for comparison purposes. In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited. Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad. There is no regulation requiring direct-to-consumer ads illegal under Canadian law to be removed or substituted when U.S. television channels and print publications are distributed within Canada. In 2014, York University professor and physician Dr. Joel Lexchin, and University of British Columbia associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations "[lacked] accountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement". Europe In October 2002, the European Commission voted against a proposal to selectively allow advertising of "disease education information" in relation to AIDS, asthma, and diabetes. Despite insistence otherwise due to its selective and controlled nature, the European Parliament Committee on the Environment, Public Health and Food Safety assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information. UK Labour Party MEP Catherine Stihler argued that the proposal was a "slippery slope" towards U.S.-style advertising practices promoting expensive "wonder drugs", and that "we don't want consumers sitting on their couches bombarded with a hard sell from big drug companies in the advertising break between Crossroads and Coronation Street." Hong Kong Under the Undesirable Medical Advertisements Ordinance, advertising of medications is only legal for "minor" diseases, such as coughs and colds, headaches, indigestion, and others. Ads may not include depictions of treatment, medical professionals, or dramatizations of symptoms. New Zealand Under the Medicines Act of 1981, and regulated by the Therapeutic Products Advertising Code and a self-regulatory code by the industry group Medicines New Zealand, New Zealand is one of the only countries beside the United States to allow direct-to-consumer advertising of prescription medications. An ongoing review of the Act to develop a replacement, the Therapeutic Products Bill, has faced lobbying efforts for and against the continued legality of DTCA. United Kingdom Advertising materials directed towards the general public are prohibited from containing any references to prescription-only medications, under the basis that they are not be presented as a consumer's choice. The home page of a drug manufacturer's website also constitutes advertising material, and thus may not include references to prescription products either. In a 2005 Health Select Committee hearing, GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept. United States Under the regulations of the Food and Drug Administration (FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major side effects and contraindications in the main body, with a "fair balance" in its coverage of benefits to risks. Unless they are given "adequate provision" via a variety of different outlets, ads must also include a "brief summary" of all risks associated with the medication. In print ads within magazines, this summary is typically given on a second page. Print ads must contain a standard notice that instructs patients to report negative side effects to the FDA's MedWatch program. In ads carried on broadcast media, such as television commercials, only the major side effects are typically listed, and the ad contains blurbs directing viewers to where they can obtain more information (the aforementioned "brief summary"), such as on a website, phone hotline, or a current magazine issue. If the drug is subject to a boxed warning from the FDA (which indicates a serious risk), the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited. Ads that do not make health claims do not fall under the FDA's jurisdiction, but can still be regulated by the Federal Trade Commission. Early history In 1962, the United States Congress gave the FDA the authority to regulate prescription drug labeling and advertising, but the FDA did not establish regulations until 1969. These required that ads for prescriptions include information on their major side effects and contraindications, and unless they have "adequate provision" via different outlets, a "brief summary" of all side effects and contraindications. Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine. However, a larger movement towards autonomy in health care decisions prompted the first prominent examples of direct-to-consumer advertising. Merck published the first print DTC ad for a pneumonia vaccine (with a particular focus on those aged 65 years or older), and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen. The advertisement promoted it as a cheaper alternative to the leading brand Motrin, and did not contain health claims. The FDA briefly demanded that the Rufen ad be pulled, but it was restored after minor amendments. As its guidelines were not written with mass media in mind, these early campaigns prompted concern from the FDA, especially after the arthritis drug Oraflex (whose release had been backed by a significant PR campaign) was recalled after only five months on the market, following reports of adverse reactions and deaths. FDA commissioner Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations. The moratorium was lifted in 1985. The industry felt that the requirement for a "brief summary" of all side effects was designed with print media in mind, and that their increasing length and technical language (often taking up an entire separate page of fine print when published in a magazine) made television advertising of prescriptions unfeasible. By the 1990s, there were calls for the FDA to loosen its regulations to make the concept viable. Partial deregulation A 1996 marketing campaign for then-prescription allergy medication Claritin found a loophole, by intentionally excluding information about the medication itself from its advertising. Clartin's television commercial contained only imagery, slogans such as "It's time for Claritin" and "Clear days and nights are here", and instructions to ask a doctor or call a phone number to request more information. In 1997, the FDA issued new guidelines that intended to make DTCM on radio and television less burdensome. In particular, the FDA clarified that informing the audience of where the "brief summary" can be obtained (such as a magazine ad, phone hotline, or website) constituted "adequate provision" of risk information, and thus relieved them from being included in the ad. The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not make any claims or statements regarding the indications and benefits of the medication. The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $
$5.2 billion in 2016. Types The U.S. Food and Drug Administration (FDA) defines several common types of DTCA for prescription medication. It classifies a "product claim" advertisement as one that identifies the scientific name and trademark brand name of the medication, and contains at least one approved indication for the drug, and claims surrounding its benefits. A "reminder" advertisement serves primarily to build brand recognition rather than promote the drug's uses and benefits. A reminder ad cannot contain any information or imagery that pertains to the drug itself, including benefits or how it functions, but may still contain a call to action urging viewers to ask their doctor or seek an external resource for more information. Reminder ads may include themes that vaguely allude to the drug's purpose: for example, a reminder commercial for the erectile dysfunction drug Viagra featured the showtune "Good Morning" and scenes of a man happily walking to work, emphasizing a sexual innuendo in the lyric "it's great to stay up late". A "help-seeking" advertisement is not presented as marketing for a drug first and foremost, and instead resemble an awareness campaign for a specific medical condition. They do not specify any specific product or treatment, and direct the audience to ask their doctor or seek an external resource (such as a website or phone hotline) for more information. These outlets are, in turn, used to promote specific prescription options. Awareness campaigns of this nature are sometimes used as preliminary marketing for new drugs. Reminder and help-seeking ads are often used by drugmakers to bypass the more onerous restrictions (such as the required listing of side effects), or outright prohibitions on product claims advertising, as neither of them are focused on promoting the drug itself. Sometimes, a campaign may mix both of these ads, with one ad discussing the condition, and another, similarly-styled ad, mentioning the product but not the condition, seeking to have the viewer infer the association between the ads. Legality Brazil In 2008 a new resolution from ANVISA (Control Agency for Sanitary Vigilance), Resolution 96 from December 17 was released, with focus on medication advertisements. It allows direct-to-consumer advertising of non-prescription medication, with restrictions on the type of drug and words and images that can be used, among other things. Advertisements for prescription medications can only appear in scientific, medical, or health professional journals. Canada The Food and Drugs Act prohibits most direct-to-consumer advertising of prescription medications: all direct-to-consumer advertising of drugs was forbidden until 1978, when Health Canada began to allow ads containing names, quantities, and prices only, so that pharmacies could display their prices for comparison purposes. In 2000, Health Canada adopted an interpretation of this law allowing for the aforementioned "reminder" and "help-seeking" advertisements, although U.S.-style "full product ads" that mention the purpose of a prescription remain prohibited. Later that year, Health Canada ruled that a pairing of similarly-themed reminder and help-seeking commercials ran afoul of the regulations, as their combination constituted a full product ad. There is no regulation requiring direct-to-consumer ads illegal under Canadian law to be removed or substituted when U.S. television channels and print publications are distributed within Canada. In 2014, York University professor and physician Dr. Joel Lexchin, and University of British Columbia associate professor Barbara Mintzes, published a study that highlighted 10 DTC cases between 2000 and 2011 with "unsatisfactory" responses from Health Canada. They found that Health Canada's application of these regulations "[lacked] accountability and transparency"—with no public record of complaints and enforcement besides media coverage of certain prominent cases, and no evidence that Health Canada has ever issued fines for violations. In conclusion, they stated that "since DTCA became prominent in the U.S. in the mid-1990s, successive governments of different political stripes in Canada have shown a remarkably consistent commitment to non-enforcement". Europe In October 2002, the European Commission voted against a proposal to selectively allow advertising of "disease education information" in relation to AIDS, asthma, and diabetes. Despite insistence otherwise due to its selective and controlled nature, the European Parliament Committee on the Environment, Public Health and Food Safety assessed that the pharmaceutical industry could not be trusted to provide impartial and unbiased information. UK Labour Party MEP Catherine Stihler argued that the proposal was a "slippery slope" towards U.S.-style advertising practices promoting expensive "wonder drugs", and that "we don't want consumers sitting on their couches bombarded with a hard sell from big drug companies in the advertising break between Crossroads and Coronation Street." Hong Kong Under the Undesirable Medical Advertisements Ordinance, advertising of medications is only legal for "minor" diseases, such as coughs and colds, headaches, indigestion, and others. Ads may not include depictions of treatment, medical professionals, or dramatizations of symptoms. New Zealand Under the Medicines Act of 1981, and regulated by the Therapeutic Products Advertising Code and a self-regulatory code by the industry group Medicines New Zealand, New Zealand is one of the only countries beside the United States to allow direct-to-consumer advertising of prescription medications. An ongoing review of the Act to develop a replacement, the Therapeutic Products Bill, has faced lobbying efforts for and against the continued legality of DTCA. United Kingdom Advertising materials directed towards the general public are prohibited from containing any references to prescription-only medications, under the basis that they are not be presented as a consumer's choice. The home page of a drug manufacturer's website also constitutes advertising material, and thus may not include references to prescription products either. In a 2005 Health Select Committee hearing, GlaxoSmithKline UK general manager Eddie Gray stated that the company did not plan to lobby for DTC in the region, citing prevailing consumer attitudes against the concept. United States Under the regulations of the Food and Drug Administration (FDA), direct-to-consumer "product claim" advertisements for a prescription medication must include information on their major side effects and contraindications in the main body, with a "fair balance" in its coverage of benefits to risks. Unless they are given "adequate provision" via a variety of different outlets, ads must also include a "brief summary" of all risks associated with the medication. In print ads within magazines, this summary is typically given on a second page. Print ads must contain a standard notice that instructs patients to report negative side effects to the FDA's MedWatch program. In ads carried on broadcast media, such as television commercials, only the major side effects are typically listed, and the ad contains blurbs directing viewers to where they can obtain more information (the aforementioned "brief summary"), such as on a website, phone hotline, or a current magazine issue. If the drug is subject to a boxed warning from the FDA (which indicates a serious risk), the warning must be reproduced in all advertising materials, and reminder ads for the drug are prohibited. Ads that do not make health claims do not fall under the FDA's jurisdiction, but can still be regulated by the Federal Trade Commission. Early history In 1962, the United States Congress gave the FDA the authority to regulate prescription drug labeling and advertising, but the FDA did not establish regulations until 1969. These required that ads for prescriptions include information on their major side effects and contraindications, and unless they have "adequate provision" via different outlets, a "brief summary" of all side effects and contraindications. Pharmaceutical companies shifted the focus of their marketing efforts to licensed medical doctors in the 1970s, as the FDA mandated that only doctors could prescribe medicine. However, a larger movement towards autonomy in health care decisions prompted the first prominent examples of direct-to-consumer advertising. Merck published the first print DTC ad for a pneumonia vaccine (with a particular focus on those aged 65 years or older), and Boots Pharmaceuticals aired the first DTC television commercial in 1983 for the prescription ibuprofen Rufen. The advertisement promoted it as a cheaper alternative to the leading brand Motrin, and did not contain health claims. The FDA briefly demanded that the Rufen ad be pulled, but it was restored after minor amendments. As its guidelines were not written with mass media in mind, these early campaigns prompted concern from the FDA, especially after the arthritis drug Oraflex (whose release had been backed by a significant PR campaign) was recalled after only five months on the market, following reports of adverse reactions and deaths. FDA commissioner Arthur Hayes showed reservations for the impact that DTCA would have on the industry and public health, and called for a moratorium in September 1983 pending further regulations. The moratorium was lifted in 1985. The industry felt that the requirement for a "brief summary" of all side effects was designed with print media in mind, and that their increasing length and technical language (often taking up an entire separate page of fine print when published in a magazine) made television advertising of prescriptions unfeasible. By the 1990s, there were calls for the FDA to loosen its regulations to make the concept viable. Partial deregulation A 1996 marketing campaign for then-prescription allergy medication Claritin found a loophole, by intentionally excluding information about the medication itself from its advertising. Clartin's television commercial contained only imagery, slogans such as "Clear days and nights are here" and "It's time for Claritin", and instructions to ask a doctor or call a phone number to request more information. In 1997, the FDA issued new guidelines that intended to make DTCM on radio and television less burdensome. In particular, the FDA clarified that informing the audience of where the "brief summary" can be obtained (such as a magazine ad, phone hotline, or website) constituted "adequate provision" of risk information, and thus relieved them from being included in the ad. The FDA also recognized reminder ads (such as the aforementioned Claritin ad) as not being subject to these rules, since they do not make any claims or statements regarding the indications and benefits of the medication. The industry quickly took advantage of the new guidelines: by 1998, advertising spending on DTCA had reached $