This commentary discusses pertinent issues from Hyosun Kim’s paper on ONLINE PRESCRIPTION drug PROMOTION. The study is well-designed and the findings highlight some of the consequences of the Food and Drug Administration’s (FDA’s) decision to deregulate ONLINE advertising of PRESCRIPTION DRUGS. While Kim’s findings confirm some of the early concerns, they also provide a perspective of implementation challenges in the ever-changing technological environment.

Despite increased availability of ONLINE PROMOTIONal tools for PRESCRIPTION drug marketers, evidence on ONLINE PRESCRIPTION drug PROMOTION is far from settled or conclusive. We highlight ways in which ONLINE PRESCRIPTION drug PROMOTION is similar to conventional broadcast and print advertising and ways in which it differs. We also highlight five key areas for future research: branded drug website influence on consumer knowledge and behavior, interactive features on branded drug websites, mobile viewing of branded websites and mobile advertisements, ONLINE PROMOTION and non-US audiences, and social media and medication decisions.

Hyosun Kim’s report “Trouble Spots in ONLINE Direct to Consumer PRESCRIPTION Drug PROMOTION: A content Analysis of FDA Warning Letters” aims to teach marketers how to avoid breaching current Food and Drug Administration (FDA) guidelines in their ONLINE drug PROMOTION. While Kim hopes to minimise the potential for ONLINE PROMOTION to misinform consumers and the study is carefully conducted, teaching drug marketers how to avoid the common mistakes in ONLINE drug PROMOTION is more likely to make marketers more adept at spinning information than appropriately balancing it.

Background: For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding ONLINE PROMOTION of PRESCRIPTION DRUGS advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers.Methods: The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding ONLINE PROMOTIONal activities, were content-analyzed.Results: Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in ONLINE paid advertisements, and in ONLINE videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of PRESCRIPTION DRUGS. In addition, the character space limitations of ONLINE platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling.Conclusion: Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer PROMOTION and to protect consumers from misleading drug information. PROMOTION via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media PROMOTIONs of PRESCRIPTION DRUGS.

Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with ONLINE direct-to-consumer advertising (DTCA) of PRESCRIPTION medicines. This experience is of relevance internationally as ONLINE DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and PROMOTION of unapproved (“off-label”) use. Nearly one fourth of violations involved cancer DRUGS, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of ONLINE DTCA, these cases likely reflect a small proportion of unbalanced and misleading PROMOTIONal information available on the web. The FDA is only able to review a small proportion of PROMOTIONal materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of ONLINE DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.

The above titled paper examined the Food and Drug Administration’s (FDA’s) warning letters and notice of violations (NOV) over a 10-year period. Findings from this content analysis reinforced what has been the primary issue for PRESCRIPTION direct-to-consumer advertising (DTCA) since its beginning, the fair balance of risk and benefit information. As opposed to another analysis in 2026 about this still being an issue, is there anything that can be done to prevent this problem from continuing?

This commentary explores the implications of increased social media marketing by drug manufacturers, based on findings in Hyosun Kim’s article of the major themes in recent Food and Drug Administration (FDA) warning letters and notices of violation regarding ONLINE direct-to-consumer PROMOTIONs of pharmaceuticals. Kim’s rigorous analysis of FDA letters over a 10-year span highlights a relative abundance of regulatory action toward marketer-controlled websites and sponsored advertisements, compared to branded and unbranded social media messaging. However, social media marketing efforts are increasing, as is FDA attention to these efforts. This commentary explores recent developments and continuing challenges in the FDA’s attempts to provide guidance and define pharmaceutical company accountability in marketer-controlled and -uncontrolled claims disseminated through social media.

The Comprehensive Economic and Trade Agreement between Canada and the European Union provides for an extension of Canadian patents for PRESCRIPTION DRUGS by up to 2 years. One of the arguments advanced for longer patent time is to compensate companies for the length of the overall drug development time (the time between patent application and market approval). This study investigates overall development time in Canada for different groups of DRUGS approved between January 1, 2009 and December 31, 2018 and how many of these DRUGS are eligible for up to 2 years of patent term extension. Based on a list of patents and dates of market approval, the change in overall development time for all DRUGS was calculated along with whether there were differences in development time between different groups of DRUGS. Using Canadian patent filing dates, overall development time for all DRUGS went from a mean of 2240 days (95% CI: 1832, 2648) in 2009 to 4197 days (95% CI: 3728, 4665) in 2018 (analysis of variance [ANOVA], P <. 0001). Using first global patent filing dates, overall development time went from a mean of 4481 days (95% CI: 3053, 5908) in 2009 to 6298 days (95% CI: 4839, 7756) in 2018 (ANOVA, P =. 0118). There was a statistically significant difference in the overall development mean time between small molecule DRUGS (3553, 95% CI: 3361, 3746) and biologics (3903, 95% CI: 3595, 4212), (t test, P =. 0487) when using Canadian patent filing dates but not when first global patent filing dates were used. There was no statistically significant change in overall development time among DRUGS that were substantial, moderate or little to none additional therapeutic value compared to existing DRUGS. Out of 238 DRUGS, 218 (91. 6%) would have been eligible for patent term extension with 195 (80. 7%) eligible for the full 2 years. Patent term extension does not appear to be justified based on changes in overall development time, except possibly in the case of biologics. There are also trade offs in terms of increased expenditures that need to be considered if patent terms are lengthened.