I just read an interesting MM&M piece about how measures to curb the deficit might impact the pharmaceutical industry (see “Pharma Marketing Outlook 2012: Detailing D.C.“). One small comment caught my attention: “A first draft of what is likely to be one of several not-crystal-clear guidances on social media and Internet communications has been circulating at FDA for most of the year, held up over legal worries.” [my emphasis]
Oddly, no details were offered regarding the nature of the “legal worries.” As the author of the MM&M piece probably knows, I wrote about this back in July when I suggested that a “Citizen Petition Filed by Pharma Likely to Delay Indefinitely the Issuance of FDA Social Media Guidance” (here). The petition asks for “comprehensive, clear and binding regulations” as opposed to “guidelines,” which are non-binding (ie, can easily be changed by the FDA).
Before granting a petition, FDA staffers evaluate it, “a process that may take several weeks to more than a year, depending on the issue’s complexity,” according to the FDA.
Why is this such a big deal? I have pointed out that if the petitioners — Allergan, Eli Lilly, Johnson & Johnson, Novartis, Pfizer, Novo, and Sanofi-Aventis — are not satisfied with how the FDA responds to the petition, they are likely to “take the matter to court” ( further hamstringing the FDA efforts to issue social media guidance. The number one pharma company and one of the petitioners is already on record opposing any social media guidance on first amendment grounds (see “Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media“).
In particular, the petitioners are looking for more guidance in four key areas: scientific exchange, sharing information with formulary committees and payers, providing independent third-party clinical practice guidelines, and responding to unsolicited requests for information. It seems that the FDA changed its social media agenda — thus further delaying issuance of guidance — to satisfy these specific needs (see “FDA Drops Social Media from Its 2011 Guidance Agenda“).
You can find and read the petition here.
Another, related, “legal worry” that could be holding up FDA’s issuance of social media guidance is a “friends of the court” brief to the court hearing the appeal of the Caronia off-label promotion case. This petition was filed by some of the same pharmaceutical companies mentioned above (see “Pharma Turns Up the Heat on Off-Label ‘Free Speech’ Chilled by FDA – Implications for Social Media Marketing“). The companies — who call themselves the Medical Information Working Group (MIWG) — contend that FDA’s regulations “lack coherence and clarity.” MIWG is talking about regulations regarding off-label information disseminated by regulated companies such as themselves.
This push for an end to FDA’s off-label marketing ban is the latest industry action that puts the FDA in a very weakened position viz-a-viz issuing any marketing guidance (and certainly NOT social media guidance) for the foreseeable future. The industry hopes the court case in question — the Caronia off-label promotion case — will end up in the Supreme Court. In the meantime, FDA is probably thinking “let’s wait and see what happens before we issue any new guidance that ‘lacks coherence and clarity’.”