Regulatory scenario of pharmaceutical advertisement in India,USA and Australia: A comparative study

Abstract

Advertisements are essential for sustaining growth and economic development in a world for all kinds of industries. Drug development is a protracted process and a risky business. For new product entry in the market, advertising has a noteworthy positive impact. But some pharmaceutical products advertising specially branded products is controversial and doubtful to advertisement regulations. Advertising is an important asset for any industry to reach new consumers with faith in existing consumers forms over a decade. As per the regulatory perspective in pharmaceutical advertising which is much more than advertising in the serious sense of words itself. The different county has a different legislative framework for protects consumer and company rights. Administrative bodies and lawmakers limit the possibilities of advertising for better achievements. This study emphasizes the regulatory outline of pharmaceutical advertisements in India, USA and Australia.

Keywords

Advertisements Australian Self-Medication Industry Office of Prescription Drug Promotion Food and Drug Administration Therapeutic Goods Administration regulatory

Introduction

The pharmaceutical business is one of the exceptionally managed enterprises, with numerous regulations, standards and guidelines implemented by the administration to secure the wellbeing and prosperity of general society. Advertising is a type of informative initiation.¹ Advertisement as a commercial speech globally restricted under a certain limit for protecting consumers' rights.^2,3 Advertising of pharmaceutical products through the media is the primary ambition to earn maximum profit. Advertisements in the market include healthcare supplements, medical devices, pharmaceutical brands, medical device medicine, hygiene products, non-prescription medicine and others. Advertisements are a platform for representation of symbols of quality, processor, quantity, method of use others data, place and price for any product or service which control or scrutiny by regulations for the prohibition of illegal use of advertising. Most of the pharmaceutical companies has their own set of codes or principles for the advertisements of medicinal products. Pharmaceutical promotional activity jointly controls and regulated by the government, industry and NGOs.^4,5 Unapproved use of an approved medicinal product is known as ‘off-label’ use. ‘Off-label’ promotion is illegal in most countries. Regulatory control of pharmaceutical advertisements is very tricky and problematic.⁶

India

Indian consumers are being constantly exposed to advertisements for prescription as well as non-prescription via television, internet, social media & other forms of media. knowledge about pharmaceuticals products obtained from various sources that are followed by the literate and illiterate person without consulting a pharmacist or physician which leads to self-medication practice. Celebrities and other famous spokespersons hire by the pharmaceutical advertiser for promotional products.^7,8 Currently in India, there is no focal constitutional agency for uniform regulations in the advertising business.^9,10 Pharmaceutical advertisements and promotion activities are regulated under the Drug and Cosmetic Act (1940), DMR (Objectionable Advertisements) Act, 1954 and CP Act,2019. The goal of the DMR Act was to restricted claims of witches, faith healers and voodoo experts or other professionals from influencing individuals. In India advertising allowed only for OTC and Ayurveda drugs. however, it does not legally recognize a list of OTC drugs. Ayurveda products advertisement are common in India because pre-approval for advertisement is not needed. No regulation specifies the minimum essential information requirements for an advertisement.^11,12 ASCI is a non-statutory body that completely directed and controlled the Indian advertising market. ASCI monitors and regulates advertisement for consumer interest voluntarily.^13,14

United States of America

Control on advertising and promotional activities is under the USFDA domain with the collaboration of the FTC which ensures the advertisement must be genuine and not misleading with ensuring data of benefits and hazards information to patients. On infringements of advertising laws FDA and FTC issue warning letters and product recall penalties to manufacturers. Suitable standards for pharmaceutical marketing and advancement in the United States set by the PhMRA, which is the IFPMA accredited voluntary organization.^15,16

DTCA advertising is a moderately new zone of pharmaceutical products and services promotion which is legalized only in New Zealand and USA.¹⁷ By the mid-1980s, pharmaceutical companies used to give information about prescription drugs (Rx) only to healthcare professionals. No legislation has ever prohibited DTC advertising. In 1981 first print DTC advertisements were run for the Pneumovax® vaccine by Merck. DTCA for pharmaceuticals was legalized in 1997. FDA is responsible for ensuring DTC advertising.¹⁸^,19 This authority ensuring that ads should as per 21 CFR 202.²⁰ Supervision of prescription drug advertising by OPDP to ensure that advertisements are under FDA's enactment and also scrutiny advertising to healthcare professionals in various ways like an audio conference, mailing, meeting and all other sources.^15,21

Advertising and marketing campaigns of prescribing products are classified into three types which are described in Table 1.

Table 1.

Types of DTC Ads.²²

Sr. No	Types	Purpose
1	Help-seeking ads	Encourages patients or people to talk with doctors about their disease or symptoms. Do not suggest definite drug and treatment for particular conditions and diseases.
2	Reminder ads	Ads are generally based on consumer assumptions. Companies describe only the medication's name, not the medication's utilization.
3	Product claim ads	Ad claim must be FDA approved and carry ‘Boxed Warning’ with the risk-benefit ratio of the drug utilization.

Advertising approval process in the USA

Promotional and labeling approval is mandatory for prescription products in the USA. Surveillance of pharmaceutical advertising is important for protecting consumers and better information for health care professionals. OPDP reviews prescription drug advertising and labeling to ensure the information is correct and not deceptive or misleading. Agencies should back up their advertising claims with verified solid evidence.^23,24

The Bad Ad Program is regulated by the OPDP in the CDRH by FDA in 2010.²⁵ The main goal of the Bad ad Program is to increase awareness about false and misleading advertising to health care professionals and reports about advertising and labeling materials.²⁶

Approval process of promotional labeling and prescription product advertisements is shown in Figure 1.

Australia

In Australia pharmaceutical products like patient diagnostics, medical devices or drugs described as “Therapeutic Goods” which means products for human use for healthcare purposes. Pharmaceutical advertising devotedly under the regulatory framework in Australia.³² Therapeutics advertising on any media platform about all kinds of products and services (Prescription and non-prescription) or packaging which creates a false impression on consumers is illegal as per the Australian laws. Therapeutic Goods Act,1989 is administered by the TGA which has the legal power to pre-market, post-market monitoring and withdraw advertisements approval. Section 42DL of TG Act,1989 prohibits illegal, biological and prescription product advertisements in Australian territory.³³

Advertising approval process in Australia

Advertising of medicinal products allowed for medical device, complementary and non-prescription medicines in digital and print media. But prior approval required for advertising of complementary and non-prescription medicines was mandatory in Australia before July 2020. Exclusive data is required for prior approval of therapeutics products in different forms of media. Prior approval by TGA is an essential form of advertising of therapeutics goods use in serious defects, diseases and conditions which is known as restricted representation.^34–36

Advertisement approval is a combination of self-regulation and national legislation. Two associations are responsible for advertisement approval of healthcare products in Australia are CHC: Complementary Healthcare Council, ASMI: Australian Self-Medication Industry.

Off-label promotion and advertising activities of therapeutic goods and services are restricted in the ACT.^33,37–39

Medicinal product advertising approval process is shown in Figure 2.

Figure 1.

Flowchart of prescription products advertisement approval process in the USA.^25,27–31

Figure 2.

Flowchart of Non-Prescription and Complimentary products advertisement approval process in Australia before 30th June 2020.^37–40 Note: Parliament of Australia has amended TG Act,1989 according to which the prior approval process for therapeutics goods is not needed from 1st July 2020 and approval number display is also not required for advertised approved before 30th June 2020 and advertisement approval number and exclusive data is mandatory for restricted representation.^36,40

Comparison

Pharmaceutical product advertising is unique and challenging as compared to other Industry-Specific advertisements due to a combination of complex regulatory and ethical issues. Based on the findings of the study and assessment the pharmaceutical advertisement regulatory framework of India, USA and Australia comparison is summarized in Table 2.

TABLE 2.

A Comparison of pharmaceutical advertisements regulatory framework in India, USA and Australia.

Sr. No.	Parameter	India	USA	Australia
1	Regulatory body	No official authority	FDA (OPDP) and FTC	TGA
2	Self-regulatory body	ASCI	PhMRA	CHC and ASMI
3	Prescription DTCA	No	Yes	No
4	OTC Ads	Yes	Yes	Yes
5	Approval process	Not required	Only for prescription product required	No (From July 2020)
6	Ayurveda products Ads	As ayurveda product	As dietary suppliants	As complimentary medicine
7	Off-label promotion	Illegal	Illegal	Illegal
8	Exclusive Data	Not-Specified	Yes	Yes

Conclusion

Each country has its own specific rules and regulations to address the advertising of pharmaceutical products and services. Indian scenario of advertising regulation seems very bleak as compared to those of USA and Australia. In India, Urgent needs to establish central regulatory authority for control and supervision on the industry-specific advertisement. USA advertising legalizations are strict and different as compare to other developed countries due to DTCA. Promotional and labeling approval is mandatory for prescription products. However, DTCA is still controversial because it indirectly encourages irrational medical use and pricing pressure. The pharmaceutical advertising approval process was strict process for OTC and complementary products before 30th June 2020 in Australia. CHC and ASMI have stopped reviewing the advertisement approval process.

The government agencies should identify and promotes health campaigns regarding drug information services. Through mass media and advertisement, uncontrolled information about prescriptions or Over the counter medications should with easy accessibility in range with clarity of quality in data under controlled surveillance. Policymakers should focus on online advertisement regulation for consumer privacy and security.

List of abbreviations

ACT: Australian Capital Territory

APLB: Advertising and Promotional Labeling Branch

ASCI The Advertising Standards Council of India

ASMI: Australian Self-Medication Industry

BLA: Biologics License Application

CBER: Center for Biologics Evaluation and Research

CDER: Center for Drug Evaluation and Research

CDRH: Center for Drug Evaluation and Research

CFR: Code of Federal Regulation

CHC: Complementary Healthcare Council

CP: Consumer Protection Act

CRA: Commercial Radio Australia Limited

CTD: Common Technical Document

CTVA: Commercial Television Australia

DMR: Drugs and Magic Remedies

DTCA: Direct to Consumer Advertising

e-CTD: electronic Common Technical Document

FDA: Food and Drug Administration

FTC: Federal Trade Commission

IFPM: International Federation of Pharmaceutical Manufacturers and Associations

IND: Investigational New Drug

NDA: New Drug Application

NGO: Non-Governmental Organization

OPDP: Office of Prescription Drug Promotion

OTC: Over the Counter

PhMRA: Pharmaceutical Research and Manufacturers of America

TGA: Therapeutic Goods Administration

USA: United States of America

USFDA United States Food and Drug Administration

Footnotes

Acknowledgments

The authors are thankful to the Department of Pharmaceutical Sciences and MDU Library which provided the relevant data for the review article.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

ORCID iDs

Tarif Hussian

Manjusha Choudhary

Garima Saini

Author biographies

Tarif Hussian is presently the Ph.D student of Maharshi Dayanand University, Rohtak (India).He did his M Pharm (Drug Regulatory Affairs) at Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak. He has secured the first rank among all the students (including the University & its constituent colleges) in the Master of Pharmacy.

Manjusha Choudhary is currently working as Assistant Professor in Pharmacology is University Institute of Pharmaceutical Sciences, Kurukshetra University.

Vikas Budhwar is currently working as Assistant Professor in Pharmaceutics, Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak, India.

Garima Saini is final year student of M. Pharm. (Drug Regulatory Affairs) at Maharshi Dayanand University, Rohtak (India).

References

Biegler

Vargas

Ban the sunset? Nonpropositional content and regulation of pharmaceutical advertising. Am J Bioeth 2013; 13: 3–13.

McBride

Costello

Ambwani

, et al. Digital manipulation of images of models' appearance in advertising: strategies for action through law and corporate social responsibility incentives to protect public health. Am J Law Med 2019; 45: 7–31.

Davis

Representation matters: an illustrated history of race and ethnicity in advertising. Advert Soc Quarter 2020; 21: 3–7.

Leonardo Alves

Lexchin

Mintzes

Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2019; 25: 1167–1192.

Francer

Izquierdo

Music

, et al. Ethical pharmaceutical promotion and communications worldwide: codes and regulations. Philos Ethics Humanit Med 2014; 9: 7.

Oberoi

Regulating off-label drug use in India: the arena for concern. Perspect Clin Res 2015; 6: 129–133.

Ahmad

Patel

Parimalakrishnan

, et al. Advertisement on medicines/treatment in newspapersviolating Indian laws? Int J Curr Pharm 2015; 6: 49–58.

Jayashree

Health related advertisements in audiovisual media: a content analysis in Karnataka, India. Int J Med Pub Health 2019; 9: 50–54.

Awasthi

Kakkar

Uppal

Ethics of advertisement and marketing policies: an Indian perspective. Rupkatha J 2020; 12: 3–5.

10.

Group

Pharmaceutical Advertising 2020 | India | ICLG. International Comparative Legal Guides International Business Reports, https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/india (accessed 29 October 2020).

11.

Lexchin

Drug promotion in India since 2000: problems remain. Int J Health Services 2020; June(Online): 5–7.

12.

Raj

Chandrul

Regulatory requirements for cosmetics in relation with regulatory authorities in India against US, Europe, Australia and Asian countries. Int J Pharma Res Health Sci 2016; 4: 1332–1341.

13.

The Advertising Standards Council of India – Mission. Ascionline.org, https://www.ascionline.org/index.php/mission.html (accessed 3 November 2020).

14.

Ray

Kumar

Healthcare and compliance to rules: examining Dalit literature and life. Ann Trop Med Health 2020; 23: 2.

15.

Pharmaceutical Advertising Laws and Regulations, https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/usa (accessed 10 November 2020).

16.

Kesselheim

Mello

Avorn

FDA regulation of off-label drug promotion under attack. JAMA 2013; 309: 445–446.

17.

Kees

Andrews

Research issues and needs at the intersection of advertising and public policy. J Advertis 2019; 48: 126–135.

18.

Parekh

Shrank

Dangers and opportunities of direct-to-consumer advertising. J Gen Intern Med 2018; 33: 586–587.

19.

FDA History Milestones. U.S. Food and Drug Administration, https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/milestones-us-food-and-drug-law-history. (accessed 11 November 2020).

20.

CFR – Code of Federal Regulations Title 21. Accessdata.fda.gov, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=202&showFR=1. (accessed 12 November 2020).

21.

Mulinari

Unhealthy marketing of pharmaceutical products: an international public health concern. J Public Health Policy 2016; 37: 149–159.

22.

Basics of Drug Ads. U.S. Food and Drug Administration, https://www.fda.gov/drugs/prescription-drug-advertising/basics-drug-ads. (accessed 15 November 2020).

23.

Allen

Promotional review: principles and practice. Pharm Med 2016; 30: 187–191.

24.

Blasi

The perils of direct-to-consumer advertising – mad in America. Mad in America, https://www.madinamerica.com/2020/03/perils-advertising/ (accessed 17 November 2020).

25.

Hathaway

Hom

Reznichenko

, et al. eSubmission of promotional labeling and advertising materials via the eCTD FDA gateway. Ther Innov Regul Sci 2020; 54: 1398–1403.

26.

Kalola

Dean

The United States food and drug administration and prescription drug promotion. J Innov Cardiac Rhythm Manage 2019; 10: 3588–3591.

27.

Sullivan

Aikin

David

, et al. Consumer understanding of the scope of FDA's prescription drug regulatory oversight: a nationally representative survey. Pharmacoepidemiol Drug Saf 2020; 29: 134–140.

28.

Krogulski

Best practices for submitting promotional 2253 submissions in the new module 1 specification. Ther Innov Regul Sci 2017; 51: 645–650.

29.

The Office of Prescription Drug Promotion (OPDP) .U.S. Food and Drug Administration, https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp (accessed 19 October 2020).

30.

Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs. Fda.gov, https://www.fda.gov/media/128163/download (2019, accessed 25 November 2020).

31.

Sookne

FDA guidance: providing regulatory submissions for promotional labeling and advertising materials. Healthcare packaging, https://www.healthcarepackaging.com/issues/regulatory/news/13296285/fda-guidance-providing-regulatory-submissions-for-promotional-labeling-and-advertising-materials (2019, accessed 28 November 2020).

32.

Holden

Testimonials within health advertising in Australia: an analysis of current policy. Aust Health Rev 2019; 43: 712–716.

33.

Group

Pharmaceutical advertising 2020. | Australia | ICLG. International Comparative Legal Guides International Business Reports, https://iclg.com/practice-areas/pharmaceutical-advertising-laws-and-regulations/australia (accessed 30 November 2020).

34.

Advertising: Getting started. Therapeutic Goods Administration (TGA), https://www.tga.gov.au/advertising-getting-started (accessed 1 December 2020).

35.

Letter

Australia’s TGA no longer requires pre-approval of medicine ads. Thepharmaletter.com, https://www.thepharmaletter.com/article/australia-s-tga-no-longer-requires-pre-approval-of-medicine-ads#:. ∼:text=The%20Code%20sets%20the%20requirements,Competition%20and%20Consumer%20Act%202010 (accessed 4 December 2020).

36.

Guidance for submitting an application for approval to use a restricted representation. Therapeutic Goods Administration (TGA), https://www.tga.gov.au/guidance-submitting-application-approval-use-restricted-representation (accessed 6 December 2020).

37.

Mitchell

Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2019. Legislation.gov.au, https://www.legislation.gov.au/Details/F2019L01013/Controls/# (2019, accessed 7 December 2020).

38.

Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG). Tga.gov.au, https://www.tga.gov.au/sites/default/files/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg.pdf (accessed 8 December 2020).

39.

Therapeutic goods advertising code. Therapeutic Goods Administration (TGA), https://www.tga.gov.au/publication/therapeutic-goods-advertising-code (2019, accessed 10 December 2020).

40.

End of pre-approval process for ads in specified media. Therapeutic Goods Administration (TGA), https://www.tga.gov.au/media-release/end-pre-approval-process-ads-specified-media (accessed 12 December 2020).