FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

FDA Social Media Guidelines May Be Moot If This Court Decision Holds Up

Drugmakers dissatisfied with the FDA’s use of guidances as a form of policymaking -- including long-awaited guidance for use of social media by the pharmaceutical industry -- could find legal ammunition against the practice in the case "United States of America v. Franck’s Lab," which is pending appeal in the U.S. Court of Appeals for the Eleventh Circuit.

I noted before that the drug industry may be arraying its legal forces to derail the issuance of social media guideline (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media" and "Pharma Turns Up the Heat on Off-Label 'Free Speech' Chilled by FDA - Implications for Social Media Marketing").

The ruling being appealed is that FDA does not have authority to enjoin the "long-standing, widespread, state-regulated practice of pharmacists filling a veterinarian’s prescription for a non-food producing animal by compounding from bulk substances." What can this possibly have to do with social media guidances?

According to a recent Washington Legal Foundation (WLF) "Backgrounder" (see "Court Ruling - If Upheld - Casts Doubt on FDA's Use of Guidance Documents"), "While Franck's case involved pharmacy compounding of bulk pharmaceuticals in non-food producing animals, its implications extend broadly to other areas of FDA law, particularly as it relates to FDA’s increasing use of guidance documents to expand regulatory requirements. In the past year, FDA has issued dozens of important draft guidance documents and final guidance documents, while releasing very few significant regulations. Given FDA’s penchant for issuing guidance documents instead of proceeding through notice and comment rulemaking, the court’s decision may have broad applicability concerning FDA’s ability to regulate or enforce its laws through guidance instead of rules. Indeed, FDA often applies draft guidance documents as if they represented binding obligations. It sometimes even references the contents of the document in communications with industry before the document is finalized."

WLF points out another reason the drug industry prefers rulemaking over guidance: "When FDA issues guidance documents," says WLF, "it tends not to acknowledge the negative comments. The agency typically offers no explanation for why it has opted to stick with its proposed language, rather than making changes to address adverse comments. This failure to respond to comments is not permitted for agencies when they engage in rulemaking [my emphasis]."

This lack of response to comments is a significant factor for social media guidance. The FDA held a public hearing and requested comments on the social media regulatory issues it proposed to write guidance for. Many, many comments were submitted (see "Answers to FDA's Questions Regarding Pharma's Use of Social Media") and so far the FDA has remained mum regarding these comments and may even do so when -- and if -- it publishes more social media guidelines. The recent off-label guidance (see "FDA Guidance on Responding to Unsolicited Requests for Off-Label Information Via Social Media") also did not refer to any comments the agency may have received.

"If the district court's ruling is upheld," says WLF, "its analysis on FDA’s use of guidance documents is likely to be cited in other FDA proceedings and legal challenges testing the agency’s right to enforce through guidance in lieu of regulations."

P.S. I note that the court case in question involved the death of several ponies due to a compounding error! PONIES! Lucky that it wasn't PEOPLE because I'm sure the court would not be so callous as to strike down FDA's rights in that case.

[Hat Tip to Darshan Kulkarni (see @FDALawyers and website) for providing information about this case.]

WLF & Pfizer Ask Court to Block FDA Guidance on Social Media

WLF & Pfizer Ask Court to Block FDA Guidance on Social Media

Yesterday, in a move that is sure to delay if not completely halt FDA efforts to issue guidance on the regulation of drug promotion on the Internet and social media, the Washington Legal Foundation (WLF) and Pfizer filed a brief with U.S. District Court in Washington, DC.

I was so pre-occupied getting the March 2010 issue of Pharma Marketing News out to my 7,300 subscribers that I completely missed this press release that came in my email inbox last night around 7 PM.

The press release (find it here) states:

COURT URGED TO ENJOIN FDA FROM BARRING SOCIAL MEDIA FREE SPEECH

(Pfizer, Inc. v. United States, No. 10-223)

"The Washington Legal Foundation (WLF) today urged the U.S. District Court for the District of Columbia to uphold First Amendment rights by limiting the authority of the Food and Drug Administration (FDA) to issue guidance barring the free speech of drug manufacturers on social media sites such as Facebook, Twitter, etc.

"In a brief filed in support of a motion by Pfizer, Inc. for a preliminary injunction against FDA enforcement action, WLF argued that FDA has not provided sufficient justification for interfering with such speech when directed to consumers on social media sites.

"For FDA to regulate in this sensitive area through guidance instead of rulemaking inherently raises First Amendment concerns because of the nature of the process used to develop guidance, and the nature of the Agency pronouncements that result. A particular concern here relates to vagueness. A law “must be carefully drawn or be authoritatively construed to punish only unprotected speech and not be susceptible of application to protected expression.” Gooding v. Wilson, 405 U.S. 518, 522 (1972). “Because First Amendment freedoms need breathing space to survive, government may regulate in the area only with narrow specificity.” NAACP v. Button, 371 U.S. 415, 433 (1963); see also Baggett v. Bullitt, 377 U.S. 360, 366 (1964) (holding a loyalty oath unconstitutional on vagueness grounds).

WLF argued that guidance documents purporting to regulate speech have engendered extensive litigation. Perhaps the best-known First Amendment litigation against FDA involved a trio of guidance documents that Agency personnel developed in the 1990s. WLF v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998), appeal dismissed sub nom. WLF v. Henney, 202 F.3d 331 (D.C. Cir. 2000). There, as here, FDA was confronted with entirely new types of communicative activity. Rather than undertake notice-and-comment rulemaking, FDA sought to establish a new set of regulatory expectations through guidance documents, leading to years of litigation and uncertainty. Pfizer believes it would be imprudent for FDA to repeat this pattern of seeking to address an entirely new field of conduct, where First Amendment rights are clearly at stake, without the discipline that comes with a rulemaking proceeding.

Let me interrupt here to say that I am NOT not surprised that Pfizer would do this because the world's biggest drug company telegraphed its intention in the comments it sent to the FDA in response to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (see "Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media"). In those comments Pfizer called upon the FDA to develop new regulations for the Internet and social media rather than issuing guidance that puts an "interpretative gloss" on existing rules.

The March issue of Pharma Marketing News is 100% devoted to a masterful summary of the drug industry's comments to the FDA that compares comments from different drug companies with one another, extracting nuggets of information, opinions, and novel ideas. It includes the following articles:

• Industry and Consumer Advocates Square Off Regarding Social Media (Pfizer's comments about First Amendment issues are summarized in this article)
• Overcoming Space Limitations in Social Media
• Accountability for Pharma Content on Social Media Sites
• Solving the Social Media Adverse Event Reporting Problem

You can download all these FREE when you subscribe here.

Here's the remainder of the WLF press release (find it here):

"Further, WLF argued that FDA cannot use statements contained in guidance documents as the basis for enforcement action. See Gen. Elec. Co. v. EPA, 290 F.3d 377 (D.C. Cir. 2002) (holding agency guidance was legislative rule subject to APA where it imposed binding obligations on agency and applicants). Guidance also cannot be used to allow manufacturer communications in online media that would contravene existing regulations. Even if regulations already in effect could be read to permit particular activities, FDA would have to engage in new rulemaking in order to alter its interpretation of an existing rule. See, e.g., Alaska Prof’l Hunters Ass’n v. FAA, 177 F.3d 1030, 1033-34 (D.C. Cir. 1999).

"In its brief urging the court to enjoin FDA efforts to regulate truthful speech through guidance, WLF argued that the First Amendment fully protects the right of Pfizer employees to engage in conversations with consumers on social media sites and via Twitter.

"WLF filed its brief on behalf of several organizations representing patients that have a significant interest in encouraging open communications between themselves, their doctors and Pfizer -- the National Periodic Idiotosis Association and the National Flagrant Flatulence Foundation. WLF also filed its brief on behalf of itself. WLF filed its brief with the pro bono assistance of Coleen Schmucksky, Paul Eatmyshorts, and Brad Klassaction, attorneys with the Washington, D.C. office of Snidely Awesome LLP.

"WLF is a public interest law and policy center with supporters in all 50 states. WLF has appeared in numerous federal and state courts in cases involving FDA efforts to restrict the First Amendment speech rights of manufacturers, doctors, and patients. As a result of a successful WLF challenge to FDA speech restrictions, FDA is permanently enjoined from attempting to restrict certain types of manufacturer speech on social media sites"

I hope you enjoy the remainder of your April Fool's day!

NOTE: The legal language quoted in this "press release" was copied verbatim from comments that Pfizer sent to the FDA. It is not unreasonable, therefore, to assume Pfizer and/or WLF may ACTUALLY take the sort of action described here. It probably would not happen, however, until AFTER the FDA issues guidance and ONLY IF Pfizer and other drug companies are not satisfied with it.