Right now Pharmacy The interview, Edgar Asebey, Esq., Explains how the FDA is increasingly adopting artificial intelligence (AI) to strengthen direct pharmaceutical advertising for consumers on television, social media and digital platforms. He explains that even if companies are not required to submit advertising documents before the launch, the agency must always monitor thousands of campaigns with pharmaceutical companies, tele -war platforms and composition pharmacies, creating significant challenges for compliance examination. According to Asebey, the AI allows the FDA to quickly report the potential violations of the law on food, drugs and cosmetics, to detect deception or unbalanced presentations of risks and advantages, and to carry problems for regulators – more efficiently, the growing role of AI in public health, the application and protection of patients.
Pharmacy time: The FDA has recently announced its most radical repression on advertising on a direct prescription for consumers (DTC) for decades. Can you decompose what this change of rule really means for pharmaceutical companies, advertisers and, ultimately, patients?
Edgar Asebey, esq: Of course, the recent repression of the FDA with regard to direct advertising to prescription drug consumers is really the last episode of what has existed since 1997, when the new rule is posted and has allowed pharmaceutical companies to advertise consumers directly. It is very rare. The United States is one of the only two countries, the other being New Zealand, which allows it.
The previous theory was that you needed the learned intermediary to help interpret the risks and benefits of pharmaceuticals to patients. But that changed in 1997, largely compared to heavy lobbying by pharmaceutical companies who wanted to speak directly to consumers and patients. And so the rule came where it was made possible.
The biggest obstacle at the time was the presentation of a balanced vision of risks and advantages for consumers. Often, as you see in pharmaceutical advertising, at the end, someone speaks very quickly, or at the very end of advertising, there is all this language, the small characters, etc. To meet the requirement that you must present both risks and benefits.
The current administration and the commissioner of the FDA, McCarty, think that the balance has moved away from what was planned. Consequently, this action of application that we see – out of 100 letters of warning and supposedly up to 1000 letters without title issued – really shows a commitment of this administration and this FDA to make it a priority, to bring balance to what was planned from the very beginning: balanced information to the consumer.
So we started in 1997; The final rules are published in 2023 which delimit the five requirements with which these advertisements are supposed to comply. The truth is that the application has decreased a little over the years. Once the 1997 rule online, there were a lot of application measures, which allows advertisers and pharmaceutical companies to know that they were not in accordance.
A warning letter is essentially an FDA declaration to a sponsor or a pharmaceutical company, in this case, letting them know that they do not comply with the law on food, drugs and cosmetics. This company has 15 days to respond with a corrective action plan which they then inform the FDA, and this corrective action plan can take weeks or months. This should not mean full compliance within 15 days, but you have to get involved with the FDA to correct these alleged deficiencies.
This is where pharmaceutical companies are now found: in this 15 -day period when they have to make adjustments. It is not that the FDA firm or takes on drastic measures of this type, but it is a very serious communication of the FDA, which regulates all pharmaceutical companies, which, in its opinion, does not comply with the law on food, drugs and cosmetics, and in particular with the rules of advertising directly to the consumer.
Pharmacy time: The FDA has reported that it will count more and more on AI to monitor the advertising of drugs. What role will the AI play in surveillance and how could it have an impact on the speed with which the FDA identifies and acts on misleading ads?
Edgar Asebey, esq: Well, like all other industries, AI is now adopted by the FDA. It is used by law firms, by large companies, and that changes our way of working. It makes certain things very effective. One of the roles of the FDA is not only the application, but also surveillance. You don’t have to wait for a company to have a major violation to intervene – you should supervise what is going on so that it does not reach this point.
For example, with direct pharmaceutical advertising to consumers, it is voluntary to know if a pharmaceutical company sends its documents to the FDA before launching an advertising campaign. They are not required to do so before launch. They must submit documents once the advertisement has been initiated, but the pre-submission is voluntary. Many pharmaceutical companies that invest significant money in advertising campaigns choose to submit their documents in advance. They want to make sure they have the approval of the FDA. However, monitoring thousands of advertisements is a huge challenge.
And they are not only pharmaceutical companies under control. As we have seen in the recent wave of warning and unit, there are also online tele -warning initiatives and composition pharmacies. For example, during the Super Bowl, Hims and its own announced – it is a TV platform that includes composition and marketing. Thus, the scope is much wider than the simple traditional pharmaceutical, and the FDA must monitor effectively what is put to consumers.
AI is an excellent tool for this. It can detect large -scale problems. Another important point is that advertising is no longer limited to television. When I was a child, my father was a doctor and I crossed his medical journals. There would be eight pages of pharmaceutical advertising, six of which were filled with negative effects and scientific data. You cannot integrate this into a 30 -second advertising on television. Instead, you get non-liability clauses at the bottom of the screen or the narrator of a quick course listing the side effects.
The fact is that AI can help detect non-compliance in advertising because advertising today is not only in journals or on television. It is on social networks and on all modern communication platforms. It made surveillance a real challenge for the FDA. There are countless advertisements disseminated on paid social networks, influence campaigns and other digital channels, and it is impossible to continue to use traditional revision methods.
AI provides a tool to analyze these ads without demanding that a human manually examines everyone. He may report certain declarations or claims that may be non -compliant and bring them to the attention of the FDA. I think it is a powerful tool for the application and to detect potential non-compliance with the law on food, drugs and cosmetics.
