FDA Issues Draft Guidance to Help Big Pharma and Other Firms Address Medical Misinformation
Updated
The US Food and Drug Administration (FDA) is expanding how medical industry stakeholders, including sponsors, manufacturers, and distributors, can challenge what they deem to be online misinformation about their products. On July 8, the FDA issued draft guidance designed to replace similar guidance published before the COVID-19 pandemic. The taxpayer-funded agency insists the new draft advances its mission of ensuring the public can access accurate, up-to-date, science-based information to advise decisions about FDA-regulated medical products to maintain and improve one’s health. But, thanks to the pandemic, to many, the new recommendations speak of another tale. Undoubtedly, the FDA’s new regulations aim to target the massive wave of very real corruption and FDA-led misinformation that has ascended to the surface concerning our nation’s sinister medical industrial complex.
The enforcement policy outlined in the guidance offers companies much more flexibility to respond to misinformation about their products, provides an additional communication avenue for firms beyond preexisting channels for communication and thus expands, rather than restricts, firms’ options for communications. The beefed-up protections for the true misinformation leaders come as the FDA has spent the majority of its time defending and trying to refute what they call misinformation surrounding COVID-19, the deadly mRNA jabs, and a long list of other topics stemming from the disastrous mismanagement of the COVID-19 pandemic. It must be exhausting when the masses are on to the deception. Speaking about how his agency hopes to empower companies as they address misinformation, FDA Commissioner Robert M. Califf, M.D., who led strategy and policy for Google’s Alphabet before rejoining the agency, remarked:
“Regulated industry plays a critical role in ensuring consumers have accurate information about medical products. We’ve updated our draft guidance to help further ensure industry has clarity and additional flexibility to promptly and proactively issue responsive communications to address misinformation they are seeing.
The growing spread of rumors about science and medicine continues to put patients and consumers at risk. We remain steadfast in our commitment to address this public health concern and continue to support and encourage all parties in the public health ecosystem to take an active role.”
So, how exactly will the FDA further empower the billionaire entities banking on a nation of ailing citizens? The agency’s draft guidance, which is a Q&A, has a direct focus on social media, noted that for nearly every industry that sells products used by consumers, social media platforms like X, TikTok, Instagram, and Facebook, among others, have created an environment where “false, inaccurate, and misleading information about medical products can spread rapidly to a broad audience.” To help combat this misinformation, the draft guidance notes that in 2022, the FDA launched the Rumor Control web page. Eerily resembling the guidance offered during the deep state’s shadow campaign implemented during the 2020 election to fuel their cause, the draft guidance dictates what information is accurate, what is a rumor, and how to stop the spread of false information.
Interestingly, while social media platforms across the gamut are targeted by the FDA as misinformation spreaders, TV and radio advertisements are outside the scope of the enforcement policy outlined in the guidance. But why would they be in the scope, really? We know the game. After all, television and radio are largely owned and controlled by Big Pharma. These giants pay mega bucks to advertise their often deadly products on the air morning, noon, and night every single day of the year. Only in America. But back to the guidance.
The draft guidance instructs firms who voluntarily decide to address misinformation about its “approved/cleared medical product” to hit back in the same way as the alleged misinformation. For example, suppose a firm’s FDA-approved product appeared in an internet-based short-form video posted by an independent third party on a social media platform. In that case, the firm is advised to post a short-form, tailored video response on the same social media platform. To make it more effective, the firm should identify the specific misinformation it is addressing and incorporate a segment of the original video containing the misinformation in its response video, clearly identifying the specific false, inaccurate, or misleading content it is addressing within the segment. The firm should also explain the specific location on social media along with the date of the independent third parties post that contained the misinformation.
The draft guidance suggests thirteen examples of when firms’ tailored responses to those they accuse of disseminating false or misleading statements online won’t violate the FDA’s regulations and three other examples when the rules may still apply. Examples of when the draft guidance likely does not apply include cases where, for example, a celebrity or individual shared online their experience or personal opinion on a specific drug. However, companies can still make more general statements. Further explaining its intended mission with the new guidance, the draft states:
“Note that the enforcement policy outlined in this guidance is not limited to situations in which the firm’s approved/cleared medical product is explicitly named in the identified misinformation. For example, the identified misinformation may include false information about an entire class of drugs or category of devices that includes a firm’s approved/cleared medical product (e.g., ‘statins cause earlobe enlargement’). In that case, a firm could choose to use a tailored responsive communication if one of the firm’s approved/cleared medical products is included in the referenced class of medical products.
Because, under this policy, the FDA does not intend to enforce certain requirements that help ensure that the information firms disseminate about their medical products is truthful, non-misleading, and consistent with the FDA-required labeling, it is important that this policy be drawn sufficiently narrowly so that it helps support firms’ voluntary efforts to address misinformation but does not undermine the purposes of those requirements.”
Time will tell, but the draft guidance sounds like more freedom—and less FDA oversight—for Big Pharma and its healthcare villains. As we stand at the crossroads between truth and misinformation in American healthcare, it’s important to remember that stakeholders—that means the American population—are not just bystanders in this process. Your feedback is crucial. You can comment on the draft guidance until September 9, 2024. Your input will shape the future of how we, the people, combat misinformation in the medical industry, and highlights the problem of trusting corrupt government agencies like the FDA for trustworthy information that isn’t ultimately tied to control and greed.