Another IRS free-speech scandal

By David B. Rivkin and Randall John Meyer

November 23, 2018, in the Wall Street Journal

The Internal Revenue Service infamously targeted dissenters during President Obama’s re-election campaign. Now the IRS is at it again. Earlier this year it issued a rule suppressing huge swaths of First Amendment protected speech. The regulation appears designed to hamper the marijuana industry, which is still illegal under federal law although many states have enacted decriminalization measures. But it goes far beyond that.

The innocuously named Revenue Procedure 2018-5 contains a well-hidden provision enabling the Service to withhold tax-exempt status from organizations seeking to improve “business conditions . . . relating to an activity involving controlled substances (within the meaning of Schedule I and II of the Controlled Substances Act) which is prohibited by federal law.” That means that to obtain tax-exempt status under any provision of the Internal Revenue Code’s Section 501—whether as a charity, social-welfare advocacy group or other type of nonprofit—an organization may not advocate for altering the legal regime applicable to any Schedule I or II substance.

Marijuana is a Schedule I substance, meaning the Food and Drug Administration has found it has “no currently accepted medical use and a high potential for abuse.” Schedule II drugs include such widely prescribed medications as Adderall, Vyvanse, codeine and oxycodone. The IRS can deny tax-exempt status to any organization that seeks to improve the “business conditions” of a currently prohibited activity involving these medications. That could include simply advocating for a change in the law or regulation forbidding the possession, sale or use of marijuana or other Schedule I substances. It would also encompass advocacy for relaxing the regulatory regime currently governing the production, distribution or prescription of Schedule II medications.

The rule does not apply to all speech dealing with the listed substances, only that involving an “improvement” in “business conditions,” such as legalization or deregulation. Efforts to maintain restrictions or impose additional ones are fine by the IRS. This is constitutionally pernicious viewpoint discrimination. As the Supreme Court stated in Rosenberger v. University of Virginia (1995): “When the government targets not subject matter, but particular views taken by speakers on a subject, the violation of the First Amendment is all the more blatant.”

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A Legal Cure For the FDA’s Free Speech Malady

By DAVID B. RIVKIN JR. And ANDREW GROSSMAN, May 21, 2015

We are free to tell you that a clinical trial shows the drug Vascepa to be an effective treatment for persistently high triglyceride levels. But should the drug’s manufacturer, Amarin, tell you or your doctor the same thing, the company would face criminal prosecution and civil liability. Therein lies a First Amendment anomaly, one that may finally be resolved by a lawsuit that Amarin filed earlier this month against the Food and Drug Administration.

The FDA has long banned promotion of drugs for uses other than those it has approved. Yet so-called off-label uses are legal and account for about 20% of all prescriptions. Some off-label uses of drugs have even become the standard of care for particular conditions.

But the drug’s manufacturer and its agents—and only them—cannot legally talk about this. Patients can—and do—discuss off-label uses of drugs endlessly in online forums. Doctors certainly exchange information about these uses.

But Amarin can’t say anything about the Vascepa trial. The drug is approved only as a treatment for “very high” triglyceride levels, not those that are merely persistently high. As a result, doctors and their patients are being kept in the dark about a treatment that, for some patients, has fewer side effects than other drugs.

The FDA claims its speech ban is a necessary part of its drug-approval process, which requires manufacturers to demonstrate efficacy for each intended use. The agency aggressively investigates and the government regularly prosecutes pharmaceutical companies and their representatives that promote off-label uses of their drugs. Yet once a drug is approved, doctors can prescribe it for any use—and the FDA recognizes, in its regulatory guidance—that such uses are essential to effectively translate medical research into improved health outcomes.

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