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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Enduring incivility for the sake of free speech

By David B. Rivkin Jr. and Andrew M. Grossman — Sunday, April 19, 2015

First Amendment lawyers always get asked the same question: Is he really allowed to say that?

The “he,” inevitably, is some television pundit, newspaper columnist or blogger. And the “that” is a stream of invective. A pointed example is economist Paul Krugman’s characterization of Rep. Paul Ryan’s 2012 budget proposal: “The most fraudulent budget in American history. And when I say fraudulent, I mean just that.”

So if he meant “just that,” the question goes, isn’t that libel, and why isn’t Mr. Ryan suing him for damages?

And from time to time, we’ve heard the same question raised about one of our own cases, climate scientist Michael Mann’s lawsuit against detractors who harshly criticized his “hockey stick” research. We represent two of the defendants, the Competitive Enterprise Institute and its adjunct fellow, Rand Simberg. They called Mr. Mann’s work “intellectually bogus” and biased “data manipulation” done “in the service of politicized science.”

So is it libel? Some may respond with a smirk that truth is an absolute defense, but the answer is actually more basic: There’s nothing to be proven true or false.

Libel law is subject to the First Amendment. Its guarantee of freedom of speech wouldn’t be worth much if the government could authorize private citizens to sue one another over their views. At a minimum, a challenged statement must contain (in the Supreme Court’s formulation) a “provably false factual connotation.”

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Judicial candidates face loss of free speech rights

David B. Rivkin Jr., and Andrew M. Grossman, January 18, 2015

For years, those who favor restrictions on campaign spending have insisted that their real interest lies in fighting corruption, not limiting political speech. Well, here’s a free-speech litmus test: Can a state block candidates from asking for campaign contributions that are themselves legal?

That’s the issue the Supreme Court will face Tuesday in Williams-Yulee v. The Florida Bar. Like most states, Florida elects or retains judges by popular vote. Many of those states prohibit judicial candidates from personally soliciting campaign contributions. This restriction, supporters say, prevents corruption, bias and the appearance of bias.

It’s hard to see how. Florida’s law allows contributions of up to $1,000 to judicial campaigns, and that limit cannot be significantly lowered (much less banned) without violating the First Amendment. Florida’s law allows judicial candidates to learn who their contributors are and to ask for other kinds of campaign support, including volunteer work and service on their campaign committees.

But a judicial candidate cannot post a request for support on the campaign website, cannot appear before a local civic group to request contributions, and cannot sign a fundraising letter asking for support. In other words, a candidate can accept contributions, just cannot solicit them. But solicitation is just speech.

That last restriction is the one that bit Lanell Williams-Yulee, a public defender and first-time candidate seeking election to a county court. She made the mistake of signing a letter announcing her candidacy and asking friends to contribute whatever they could. For that, she was reprimanded and fined by the Florida Supreme Court. Read more »

Criminalizing Political Speech in Wisconsin

By David B. Rivkin Jr. and Andrew Grossman

The criminalization of politics is bad enough—just ask Texas Gov. Rick Perry—but a new turn to target citizens as well threatens to permanently warp our political discourse. Like it or not, federal courts will have to intervene to uphold Americans’ First Amendment rights against win-at-any-cost politics.

Wisconsin is ground zero of this phenomenon. A partisan elected district attorney, John Chisholm, reportedly goaded on by his union-steward wife, Colleen, decided to take aim at Republican Gov. Scott Walker after his 2011 “Budget Repair Bill” cut back on public-sector collective bargaining within the state. But Mr. Chisholm didn’t stop there: After an aggressive criminal investigation failed to knock Mr. Walker out of office, the district attorney set his sights on the governor’s philosophical allies, an assortment of conservative citizen groups that supported Walker’s reforms.

The claim was that these groups illegally “coordinated” their speech on the issues with Gov. Walker’s campaign, thereby circumventing campaign-finance regulations. The evidence? Intercepted emails and phone records showing that some of the groups communicated with Gov. Walker’s campaign, mostly on policy issues. That wasn’t enough to bring charges, but it did allow Mr. Chisholm to launch an aggressive criminal investigation targeting Gov. Walker’s supporters, complete with home raids and everything-but-the-kitchen sink subpoenas.

These efforts had the intended effect: Funding for conservative policy advocacy dried up and Gov. Walker’s supporters were forced to redirect their energies from political activism to courtroom litigation.

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Your DNA and your First Amendment

The FDA is blocking 23andMe’s genome service. But the real target is free speech.
 

By David Rivkin Jr. and Andrew Grossman 

Did you know that you cannot be trusted with knowledge of your own genetic background? That’s what the Food and Drug Administration decreed late last month when it ordered 23andMe to stop marketing its Personal Genome Service.

23andMe is at the cutting edge of mass-market genomics. For $99 the company tests a saliva sample to identify genetic markers that correspond to various conditions and predispositions, as well as ancestry. Based on these markers, the company produces a report describing genetic health risks and inherited traits, along with citations to the research that backs up its analysis and the current scientific “confidence” for each point.

The FDA does not claim that 23andMe is a scam or could cause direct injury. Instead, its concern is that people using the genome service may begin to self-manage their treatments. Essentially, the agency wants to “protect” patients from knowing about their own health.
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David Rivkin on the Constitutional Controversy of the IRS Scandal

Constitutional attorney David Rivkin spoke with Bill Bennett during his show “Morning in America” about the recent hearings for the IRS scandal. Rivkin presents the constitutional controversy, as well as speaks about the Lois Lerner hearing, the recusal, and the Holder Administration. Rivkin also presents how the treatment by the IRS is hindering First Amendment rights and predicts how the scandal will progress in the future.