Digital marketing model of foreign pharmaceutical market: FDA regulation and actual data of pharmaceutical enterprises

In order to ensure the true and accurate delivery of information to the public, the FDA's office of prescription drug promotion (opdp) is responsible for the supervision and review of drug labels, advertisements and promotional materials All drug promotional materials distributed in the United States must be submitted to opdp for review If there is any violation of the promotional materials, FDA will issue a regulatory letter to the company If the company fails to correct the incorrect behaviors in time and properly, it may eventually lead to law enforcement actions, such as recall, seizure, prohibition, administrative detention and criminal prosecution From 2005 to 2016, the FDA issued 296 regulatory letters on the violation of drug publicity materials Among them, the year with the largest number of regulatory letters was 2010, with a total of 52 Next came 2009 and 2011, 41 and 31, respectively From 2005 to 2008, there was no significant difference in the frequency of issuing regulatory letters for illegal drug promotion materials, which peaked in 2010 after a substantial increase in 2009 Subsequently, the number of regulatory functions decreased significantly from 2014 to 2016, with a total of only 29 There are two types of regulatory letters: (1) Warning letter: for serious violations; (2) Untitled letter: violation, but less serious than warning letter 2 Types of violations In 296 letters on drug advertising supervision, 1203 violations were mentioned, involving 15 types of violations: (1) Omission or lack of risk information prompt: advertising or promotional materials omit the possible consequences of the proposed use of drugs; (2) Inadequate risk information prompts: the publicity materials fail to show the drug risks in a visible way to consumers; (3) Misleading drug efficacy: the publicity materials misrepresent the efficacy of drugs; (4) Misleading drug advantages: advertising the drug is more effective than the drug with a large number of clinical experience; (5) Unconfirmed drugs: promoting drugs without substantial clinical experience or clinical data support; (6) Expand indications: expand the scope of indications of drugs; (7) Non label use: drug promotion materials do not follow the FDA approved packaging label for publicity; (8) Label problem: incorrect label instructions, dosage, etc; (9) Comparative publicity: the inducer thinks the drug is safer and more effective than other drugs; (10) Failure to submit form fda-2253: the company fails to submit form fda-2253 to the agency; (11) Information Imbalance: the imbalance between drug risk information and drug benefit information; (12) Promotion of new research drugs: FDA prohibits the promotion of new drugs that are still in the stage of research and test; (13) Omission of important facts: important information, such as indications approved by FDA, is omitted from publicity materials; (14) Inaccurate expression of place names: promotion materials fail to display place names directly in proprietary names; (15) Other illegal acts Specifically, the most frequently mentioned violation is "omission or lack of risk information prompt", which has been mentioned 203 times by regulatory letter, accounting for 16.9% However, "insufficient risk information" was mentioned 118 times (9.8%) Other major violations include "drug efficacy misleading" (167 times, accounting for 13.9%) and "drug advantage misleading" (131 times, accounting for 10.9%) "Drugs without sufficient clinical evidence or experience" (124 times, accounting for 10.3%) 3 Promotion of illegal channel platform Here, the media channels for drug promotion are divided into: (1) Traditional media: brochures, sales aids, print ads, mailing, oral statements of sales representatives, exhibition banners, electronic display screens, billboards, etc; (2) Network media: company website, company sponsored website or link, social media Facebook / YouTube / twitter, email, online advertising, etc; (3) Video; (4) Other publicity materials According to the statistical results, in 296 regulatory letters, the media channels of drug promotion mentioned 337 times Among them, 64.1% of them are illegal in traditional media, while 25.5% are illegal in network media The most frequent carriers of publicity violations are product brochures, 59 violations, 17.5%, followed by the company's website, 51 violations (15.1%) Other media with more violations are sales assistance and print advertising The number of website or link violations sponsored by the company increased significantly in 2009 4 Network media Interestingly, the research found that in the past 12 years, there is a perfect negative correlation between the frequency of violations in traditional media and the frequency of violations in online media In recent years, the proportion of illegal drug advertisements on the Internet has increased Until 2016, traditional media and Internet platforms accounted for half of drug advertising violations 5 Requirements of regulatory letter for illegal enterprises In the regulatory letter, FDA will provide three options for the illegal enterprises: (1) Immediately stop the dissemination of illegal publicity materials and give a written reply to ddmac to indicate whether it complies with FDA requirements (2) Immediately stop the dissemination of illegal publicity materials, give a written reply to ddmac to indicate whether it complies with FDA requirements, and submit an action plan to stop the use of such materials (3) Immediately stop the dissemination of illegal publicity materials, give a written reply to ddmac to indicate whether it complies with FDA requirements, and submit an action plan to stop the use of such materials Further check the promotional materials of other prescription drugs promoted by the company in the United States (ddmac, the pharmaceutical marketing promotion and communication department is the predecessor of opdp) In 296 FDA regulatory letters, most of the requirements are for enterprises to stop immediately, or stop immediately and submit an action plan Only a handful of regulatory letters urge companies to check the materials of other prescription drugs 6 Type of company receiving regulatory letter During the 12 years, one company received one supervision letter, and some received 11 21 companies received 3 or more regulatory letters These regulatory letters are mainly sent to large well-known companies in the United States Most of them are private companies, covering all core businesses, including R & D, manufacturing, operations, and marketing and sales The second is only engaged in R & D companies and only engaged in sales and distribution activities In addition, 46% of all companies receiving regulatory letters are foreign subsidiaries and 26% are biotechnology companies A survey selected top 20 pharmaceutical companies around the world, looked up and analyzed the digital marketing data of top 20 pharmaceutical companies on three mainstream social media, Facebook, twitter and Youtube in 2015 and 2017, in order to find evidence of their activities on social media Research result 1: most pharmaceutical companies conduct cross platform digital marketing Of the 20 pharmaceutical companies surveyed, 12 (60%) did online marketing on three social media On the contrary, there are two companies that do not appear on these social media, both of which are Japanese pharmaceutical companies: Takeda pharmaceutical and the first three companies Interestingly, twitter remains the platform of choice for most companies, despite its limitations on content length In this survey, except for two that do not conduct social media marketing, the other 18 chose twitter Facebook and Youtube are about the same, with 14 and 15 pharmaceutical companies on social media Survey result 2: social media participation of most pharmaceutical companies remained stable or slightly increased After collecting the data, the next step is to use the participation formula to calculate the participation of each pharmaceutical company on each platform Due to the different operation of each platform, the formula of participation is also different (see the figure below) Based on the above formula, the participation on three social media of pharmaceutical companies is evaluated in 2015 and 2017 The results are as follows: 1 In 2015 and 2017, social media participation of most pharmaceutical companies remained stable or slightly improved In particular, Bi attaches great importance to social media, and its participation in all three platforms has increased In 2017, Twitter's participation was twice that of 2015 Bi is also the most active pharmaceutical company on Facebook 2 Social media participation is not directly proportional to the company's size and operating income Johnson & Johnson, Roche and Pfizer, the three largest pharmaceutical companies in the world, are not at the forefront of the three social platforms 3 Lilly is active on Facebook and twitter platforms Although Teva is in the back end of top 20, it is very active on twitter, and its participation has doubled compared with Lilly, the second place Abbott's participation in Facebook and Twitter is not high, but it is extremely active on YouTube Survey result 3: posts in the pharmaceutical enterprise zone Research and analysis of 2014 and 2017 Facebook pharmacy column posts Posts are divided into two categories: (1) brand side posts, (2) user posts From the brand side posts, Bi is the most active, while Roche gene tech and AZ are the least active For user posts, only six pharmaceutical companies (Merck, Roche, Abbott, Bayer, Bi, Novo Nordisk) have posts published by users in the message wall of Facebook zone, and the user activity of each zone is different In addition, every pharmaceutical company has a comment function in its Facebook zone The company with the most user comments is Bi, with 1660 comments, accounting for 76% of all comments (2015), which is very similar to the number of comments in 2017, with a slight increase As far as user reviews are concerned, Roche is the second largest user in the Facebook zone, with 208 entries accounting for 10% Although Roche ranks second in the number of user reviews, it still has a big gap with Bi Survey result 4: types of Posts released by brands After counting the number of Facebook posts, let's take a look at the form of post publishing The research divides the content of post publishing into four forms: link, picture, video and status publishing In 2014, the brand side of pharmaceutical companies used more pictures to post, with 59% of the posts posted by pictures By 2017, the forms of Posts became diversified, the four forms were more evenly distributed, and the proportion of picture Posts decreased The second one is the posts with links, accounting for 24% in 2014 and 32% in 2017 In 2014, the form of status publishing and video posts was relatively rare, and by 2017, the number of video posts had increased significantly Survey result 5: Twitter activity and response speed From the perspective of twitter platform, three pharmaceutical companies (Bi, Johnson & Johnson, Novartis) have sent more than 5000 tweets in 2017 since they opened twitter accounts Among them, Bi leads, with 6940 tweets (16%), followed by Johnson & Johnson 6069 (14%) and Novartis 5641 (13%) From Twitter users' requests and the corresponding speed of pharmaceutical companies' customers, we can see the activity of various pharmaceutical companies In a specific research time, the most active company is Johnson & Johnson, which has 48 customer service responses, accounting for 48% of the total corresponding number Bi is the only company that can respond within an hour Survey result 6: diffusion effect and local activity in twitter environment To further analyze the network structure of twitter, researchers used the latest data and nodexl software to study the global diffusion effect of top pharmaceutical company (see the figure below) First, Pfizer, Harel Koren's fast multi-layer layout algorithm shows that Pfizer can trigger a pseudo-random network with five clusters, each cluster is connected to a specific country, that is, it can trigger multiple countries at the same time, while the U.S