Two secondary response

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Each secondary post only 1 paragraph.

1. There are many benefits to DTC advertising. It informs patients of their options, potential side effects, and encourages them to open a dialog with their physicians. DTC advertising has also been a key to destigmatizing mental health issues like depression and helping patients realize that they are not alone in their suffering. However, these benefits can all be obtained by mandating that pharmaceutical companies put money into disease state education for patients when they market product to physicians, or simply allow them to provide disease state education to patients. Because the cons of DTC advertising far outweigh the pros.

DTC advertisements are developed, written, and implemented by people who are professional spin doctors. They know exactly how to use images, fonts, colors, graphics, words, sounds, and visuals to make the data say exactly what they want it to say. Yes, the FDA provides us with guidance, but given the number of products being advertised today, and the types of media available for promotion (social, print, digital, radio, television), it is nearly impossible for them to monitor all the promotional activity taking place on a daily basis. In 2015, OPDP send out 9 warning letters.1 This was followed by 10 in 2016, 5 in 2017 7 in 2018, 11 in 2019, and 5 thus far in 2020. I work at a large pharmaceutical corporation, and this week, for one of their smallest marketed prescription products, I sent 4 consumer and 12 professional promotional pieces to OPDP for review. We market 50 prescription products. 

To understand the impact of DTC advertising, the FDA conducted a survey of physicians in 2004.2 Most of the physicians survey did not think the ads conveyed information about risks and benefits equally well, and only 40% believed their patients understood the possible risks of the prescription drugs they asked about. 65% of physicians believed DTC ads confused patients about the relative risks and benefits of prescription drugs, and 75% believed they caused patients to think that the drug works better than it does.

Moreover, the majority of patients do not have the health-literacy to really understand the gravity of warnings and precautions being presented to them or what the safety information means. That is not a patronizing statement. Consumer advertising is, as an industry standard, written at a 6th grade level.3 It is nearly impossible to explain how a drug for multiple sclerosis can lead to idiopathic thrombocytopenic purpura in 6th grade terms. The gravity of it will be diluted when the language is. To add to this, it is critical to realize that the majority of advertising is done when the drug is first marketed. This means that the post-marketing data, the serious side effects that are realized after the drug is used by a substantial number of patients, are yet unknown. To promote nascent drugs to a nave audience with a regulatory authority that can barely

2. In my opinion, I do not see any issues with Direct-To-Consumer (DTC) advertising and in fact it is one of the effective ways to inform the public or the consumers about a potential biomedical product that could bring a solution to any unprecedented events prevailing in the society as long as the ads are truthful, balance and accurately communicated.

FDA has actively involved itself when it comes to advertising and other types of promotions related to biomedical products. FDA has already released a guidance on Consumer-Directed Broadcast Advertisements for the industry to assist the manufacturers who are interested in DTC advertising of their prescription drugs, including biological products for humans. However, it has been mentioned that pharmaceutical companies are not required to submit promotional materials to FDA before they are actually used. I do not think, this is a good idea because there is no point holding a manufacturer responsible for inaccurate promotion when it has already reached the public. It is good to catch false promotion, but it could be better if it was caught before it went public so that unnecessary commotions among the public is prevented about the product. In order to prevent this, FDA has released a draft guidance for the industry titled ‘Direct-to-Consumer Television Advertisements- FDAAA DTC Television Ad Pre-Dissemination Review Program’ which informs manufacturers about which ads qualify for pre-dissemination review program.

Further, the guidance prevalently talks about the ads related to drugs and biologics. I believe it should also emphasize on ads associated with medical device promotions. I believe DTC advertising is not a bad idea because it gives a greater reach and the manufacturers should ensure the claims made in the promotions are what the product is intended for. It would be great if FDA regulates all the ads associated with any biomedical product promotions prior to the release rather than monitoring them in various ways.

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