In Amicus Brief, PhRMA Says Off-label Case “Raises Serious First Amendment Concerns”

Sept. 19, 2014 – Stating that a whistleblower’s interpretation of the False Claims Act has “a critical flaw” because it “threaten[s] core First Amendment rights,” an amicus curiae brief filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) asks the U.S. District Court for the Eastern District of California to dismiss the case. PhRMA contends that the case’s premise, brought by Frank Solis (relator), a former sales representative at Schering-Plough Corp. and Millennium Pharmaceuticals Inc., would impose liability on those manufacturers for engaging in truthful speech about off-label uses for their drugs when the First Amendment “unquestionably protects such truthful and non-misleading speech.”

Solis alleged that the two pharma companies named in the case marketed a heart medication illegally by promoting off-label uses to physicians, causing medical claims to be filed with the government in violation of the Federal Food, Drug & Cosmetic Act (FDCA) and the False Claims Act; PhRMA argues that manufacturers must be permitted to speak truthfully about their products, and that this speech is protected under the First Amendment and is supported by recent court decisions.

“In very simple language, this case is important because it brings forward the First Amendment challenge to off-label cases under the False Claims Act,” said Coalition for Healthcare Communication Executive Director John Kamp. “PhRMA argues that truthful information about drugs gleaned from reports in peer-reviewed journal articles – even when that information is about off-label uses – cannot support a False Claims Act allegation.”

Specifically, PhRMA asserts in its amicus brief that the relator’s interpretation of the FCA is “constitutionally suspect” and that the government’s interpretation of the False Claims Act creates “grave First Amendment problems.” For example, the brief cites court decisions in Caronia v. United States and Sorrell v. IMS Health Inc. as establishing that the FDCA does not prohibit off-label promotion or restrict free speech, and that speaker- and content-based restrictions are not defensible. “Truthful and non-misleading speech about unapproved uses cannot be a violation of any requirement that is a condition of payment under any federal healthcare program,” the brief states.

Further, PhRMA refutes the government’s interpretation that manufacturers who lawfully provide peer-reviewed, off-label information to physicians “are prompting the submission of reimbursement claims that are ‘false’ because the claims are ‘ineligible for payment in light of applicable law.’” PhRMA notes that the “remote and highly attenuated link between the manufacturer’s free speech and the hospital’s ultimate decision to submit a reimbursement claim make this the quintessential case where imposing liability would raise serious First Amendment concerns.”

If the court agrees with PhRMA, according to Kamp, “it could radically change the ability of the government and whistleblowers to prosecute drug companies for such off-label promotion. In turn, it would put even more pressure on FDA to modify its off-label marketing regulations.”

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