As we all know, the Food and Drug Administration — the FDA — looks out for us, in terms of determining which poisonous substances are allowed to qualify as food, or as drugs.
Lately, they’ve updated their guidance to further empower corporations to address the spread of misinformation. We don’t want just anyone spreading misinformation. That’s the job of corporations and government.
From a recent FDA press release:
Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products…
Some people may wonder if this is appropriate subject matter for a humor column. But I embrace the philosophy that, sometimes you have to laugh to keep from crying.
From FDA Commissioner Robert M. Califf, M.D.:
“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.”
I didn’t know that public health had its own ecosystem. You learn something new every day. But we can guess why the FDA would want drug companies to take an active role in defending their own products. The products are approved or cleared by the FDA, so public, unauthorized criticism of an approved drug… like, say.,Cylert… might reflect directly on the FDA.
Cylert was made by Abbott Laboratories and was used to treat ADD and ADHD from 1975 until 2010 when it was finally recalled by the FDA due to an unpleasant tendency to cause liver damage.
The liver damage was noted by doctors in 1984. The FDA allowed the public health ecosystem to continue selling Cylert until 2010. I guess they finally decided it had ruined enough livers.
Anyway, we can understand that the FDA dislikes seeing information posted — especially on the internet — about dangerous drugs or questionable therapies, and why they might want to support drug companies that “issue certain kinds of internet-based communications (‘tailored responsive communications’) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party.”
Obviously, the term “misinformation”, as used here, means, “didn’t come from the FDA or the drug companies.”
The FDA doesn’t like anyone making claims that the FDA hasn’t approved in advance. But if the claims are ‘tailored responsive communications’ then the FDA is not going to get too bothered about it.
To reassure drug companies that they ought to feel free about defending their products, the FDA wrote up a guidance document:
Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers
To understand the policy, a drug company should reference other FDA rules about what you can and can’t say about your product.
See, e.g., 21 CFR 314.81(b)(3)(i) and 601.12(f)(4) (regarding postmarketing submissions of promotional communications for drugs and biologics for human use using Form FDA 2253); section 506(c)(2)(A)(ii) of the FD&C Act (21 U.S.C. 356(c)(2)(A)(ii)); 21 CFR 314.550 and 21 CFR 601.45 (regarding submissions of promotional communications for accelerated approval products); section 506(h)(3)(B) of the FD&C Act (21 U.S.C. 356(h)(3)(B)) (regarding submissions of promotional communications for Limited Population Antibacterial and Antifungal Drugs); 21 CFR 314.640 (subpart I) and 601.94 (subpart H) (regarding submission of promotional communications for products where human efficacy studies are not ethical or feasible); and 21 CFR 514.80(b)(5)(ii) (regarding submission of promotional communications for animal drugs).
But maybe the companies don’t need to look up all those rules, because maybe the FDA won’t be paying attention to their tailored responsive communications, anyway.
Because, under this policy, 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…
Which only seems fair, considering the third parties who are disseminating warnings about dangerous products are not playing by FDA rules. Fight fire with fire, I always say.
Curiously, the press release sent out by the FDA, about their “Addressing Misinformation” policy also included extensive information from MedWatch, the FDA Safety Information and Adverse Event Reporting Program… about 13 drugs or medical devices that are being recalled, for various reasons. We assume this part of the email was not misinformation.
Underrated writer Louis Cannon grew up in the vast American West, although his ex-wife, given the slightest opportunity, will deny that he ever grew up at all.