On September 9, 2025, the US Food and Drug Administration (FDA)
launched one of its most aggressive and comprehensive enforcement
initiatives in decades, targeting deceptive pharmaceutical
advertising practices across television, digital platforms, and
social media.
The FDA’s shift toward greater transparency and proactive
enforcement marks a turning point in US pharmaceutical regulation.
For Canadian regulators, marketers, and policymakers, this
development raises questions about the adequacy of domestic
oversight, particularly as cross-border exposure increases, and
evolving advertising formats test the limits of Canada’s
current regulatory framework.
FDA Enforcement Shift
The FDA’s concerns are that pharmaceutical advertising
frequently places disproportionate emphasis on therapeutic benefits
while minimizing or obscuring safety information. Patients are
often exposed to promotional content that highlights efficacy while
relegating serious risks to fine print or omitting them altogether,
not meeting the “fair balance” that advertising standards
require. This imbalance compromises informed decision-making and
fails to provide patients with a comprehensive and transparent
understanding of both the benefits and potential harms associated
with the medication.
In response, the FDA has shifted from a reactive,
complaint-driven approach to enforcement to proactive,
comprehensive enforcement across all media platforms. On September
9, 2025, the agency delivered over 100 cease-and-desist letters and
issued thousands of warning letters to companies demanding
immediate compliance with existing regulations.1 The FDA
has also announced its intention to conduct rulemaking to eliminate
the “adequate provision” loophole, which previously
allowed companies to satisfy risk disclosure requirements by
providing a major-risk statement in advertisements and directing
viewers to external sources for complete prescribing
information.2 Under current FDA guidance, this approach
has been considered sufficient to meet disclosure obligations. The
proposed reforms would require key safety disclosures, such as
boxed warnings and contraindications, to appear directly within the
advertisement.3 This change is intended to ensure that
risks and benefits are presented with equal prominence and
clarity.
Recognizing the rapid growth of pharmaceutical advertising on
digital platforms, the FDA is deploying artificial intelligence
tools to monitor online activity. The agency now intends to monitor
all forms of social media promotion, such as influencer
partnerships, sponsored content, algorithm-driven ads, and
telehealth promotions that blur the distinction between educational
messaging and promotional content.4 This expanded
oversight is specifically intended to close digital loopholes and
ensure that all promotional communications meet FDA standards for
accuracy and transparency.
The FDA’s focus on digital enforcement and promotional
transparency is likely to reshape consumer expectations for
pharmaceutical advertising. This shift may prompt Canadian
stakeholders and regulators to reassess how domestic advertising
standards are interpreted and applied in practice, and whether
current oversight mechanisms are sufficient to address the
influence of increasingly visible US campaigns.
Enforcement in the US and Canada
Pharmaceutical advertising rules in the US and Canada differ
significantly in both scope and enforcement. In the US, the FDA
permits direct-to-consumer (DTC) advertising of prescription drugs,
provided that such messaging includes a “fair balance” of
benefits and risks.5 Conversely, in Canada, the Food
and Drugs Act6 prohibits product-claim DTC
advertising, and permits only “reminder” ads, which may
include a drug’s name but not its use, or
“help-seeking” ads, which describe a condition without
referencing a specific product.7
Each country’s respective enforcement mechanisms highlight
this divergence in regulation. The FDA does not require
preclearance of ads before they air and has traditionally relied on
post-publication review.8 Its recent enforcement shift
marks a move toward real-time oversight and stricter standards.
As it stands, Health Canada’s enforcement remains largely
reactive, often intervening in response to complaints or identified
safety concerns. While proactive measures do exist, such as issuing
guidance and monitoring high-risk areas, the system relies heavily
on voluntary preclearance and post-publication review.9
While companies may voluntarily submit materials to the
Pharmaceutical Advertising Advisory Board (PAAB) or Advertising
Standards Canada (ASC) for review, preclearance is not
mandatory.10 Advertising content is assessed based on
promotional intent, which is in turn determined using contextual
factors such as sponsorship, message delivery, and audience
targeting.11
Implications for Canadian Pharmaceutical Advertising
Although product-claim DTC advertising is prohibited in Canada,
Canadian audiences are regularly exposed to US pharmaceutical
campaigns through television, streaming platforms, and
algorithm-driven social media platforms. This exposure is
longstanding, but the FDA’s proposed reforms have the potential
to intensify its impact.
This shift in expectations could influence prescribing behaviour
in ways that may not always align with Canada’s regulatory
intent or clinical best practices. For example, patients may
request specific drugs they have seen advertised, and physicians
have discretion to oblige, even if the drugs are newer, more
costly, or not the most clinically appropriate option.12
The recent surge in demand for GLP-1 drugs (the popular weight-loss
medication) illustrates this trend – although product-claim
advertising is prohibited in Canada, reminder ads and social media
engagement have driven brand recognition and off-label
interest.13
Canadian pharmaceutical companies and marketers should be
mindful of US enforcement trends and how the evolving tone of US
pharmaceutical advertising may shape consumer expectations in
Canada. As cross-border exposure increases, domestic campaigns may
face closer scrutiny, especially where reminder ads or influencer
content risk blurring the line between education and promotion.
Voluntary preclearance through PAAB or ASC remains a practical
safeguard, particularly for initiatives involving digital platforms
or public-facing messaging.
Conclusions
In light of the FDA’s recent changes, it would be prudent
for Canadian companies operating in the pharmaceutical space to (i)
monitor US enforcement trends, (ii) prepare for the potential of
closer scrutiny of ads and influencer content, and (iii) consider
submitting their pharmaceutical advertisements for voluntary
preclearance through PAAB or ASC, particularly for digital
campaigns and public-facing messaging.
Footnotes
1. Martin A. Makary, “The FDA’s Overdue
Crackdown on Misleading Pharmaceutical Advertisements“
(12 September 2025), JAMA Network (online), at
2. US Food and Drug Administration, “FDA
Launches Crackdown on Deceptive Drug Advertising” (9
September 2025), FDA (online), at
Martin A. Makary, “The FDA’s Overdue Crackdown on
Misleading Pharmaceutical Advertisements” (12 September
2025), JAMA Network (online), at
3. Loeb & Loeb LLP, ” FDA’s
Direct-to-Consumer Advertising “Crackdown”: Impacts to
Brands, Agencies and Influencers” (16 September 2025),
(online PDF), at FDA’s Direct-to-Consumer Advertising
“Crackdown”: Impacts to Brands, Agencies and Influencers,
Kristen R. Klesh.
4. US Food and Drug Administration, “FDA
Launches Crackdown on Deceptive Drug Advertising” (9
September 2025), FDA (online), at
5. US Food and Drug Administration, “Basics of
Drug Ads” (online), at
6. Food and Drugs Act (R.S.C., 1985, c.
F-27).
7. Health Canada, “Illegal Marketing of
Prescription Drugs” (online), at
8. US Food and Drug Administration,
“Prescription Drug Advertising: Questions and
Answers” (online), at
9. Health Canada, “Regulating Advertising of
Health Products” (2011) (pdf) at
10. David M. Gardner, Barbara Mintzes & Aleck Ostry,
“Direct-to-consumer prescription drug advertising in
Canada: Permission by default?” (2 September 2003),
Canadian Medical Association Journal (online), at
11. Health Canada, “Policy on the Distinction
Between Advertising and Other Activities” (online), at
12. Barbara Mintzes et al., “How Does
Direct-to-Consumer Advertising (DTCA) Affect Prescribing? A Survey
in Primary Care Environments With and Without Legal DTCA“
(2 September 2003), Canadian Medical Association Journal (online),
at
13. Nicole Ireland, “Rise of Ozempic Ads in
Canada Raising Concern. What Are the Risks?” (20 June
2023), Global News (online), at
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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