FDA

Does Free Speech Cause Meningitis? The New York Times Thinks So

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It was the soliciting wot done it.

New York Times columnist Linda Greenhouse isn't directly saying that the Supreme Court's 2002 decision in Thompson v. Western States Medical Center upholding the commercial speech rights of compounding pharmacies caused the national meningitis outbreak that has killed 30 people to date. She can't say for sure whether the ruling played any role. Except that's pretty clearly what she's implying.

First, some background: Compounding pharmacies traditionally mix drugs in small doses for individual patients who need products that are not available commercially. Because of the small scale, clinical trials would be prohibitively expensive and pharmacists—and patients who depend on compounded drugs—benefit from an exemption to premarket review.

Demand for compounded drugs has grown, however, and pharmacists have responded by ramping up their operations to the point where some are more like manufacturers than corner druggists. This prompted a 1997 federal law prohibiting pharmacists from speaking truthfully to doctors about the services they provide.

Here's Greenhouse:

The idea, as the government later explained to the Supreme Court, was that compounding pharmacies could continue to serve their traditional role of filling doctors' prescriptions for individual patients, but would be limited in their ability to solicit business on a big scale or to engage in large-scale drug production—in other words, to conduct the kind of multi-state business in which the New England Compounding Pharmacy (sic) was engaged before it was shut down in the wake of the meningitis cases tied to its tainted product.

In the Supreme Court's view, the government's regulatory rationale was not sufficient to justify infringing on the pharmacies' right to engage in "commercial speech." The government had failed to explain why "forbidding advertising was a necessary as opposed to merely convenient means of achieving its interests," Justice Sandra Day O'Connor wrote for the majority…."

In other words, the government cannot restrict commercial speech if there are other regulatory alternatives. And the Court identified several, including limits on how much compounders can produce and requiring pharmacists to make drugs in response to prescriptions rather than in advance of them.

Back to Greenhouse:

The notion that the First Amendment protects the advertising of goods and services, although familiar today, is not of ancient lineage, deriving only from a Burger court decision in another pharmacy-related case in 1976. Justice Stephen G. Breyer's dissenting opinion in the compounding case warned against allowing this newly minted right to trump sensible federal regulation. "An overly rigid 'commercial speech' doctrine will transform what ought to be a legislative or regulatory decision about the best way to protect the health and safety of the American public into a constitutional decision prohibiting the legislature from enacting necessary protections," Justice Breyer wrote. Then he added: "Any such transformation would involve a tragic constitutional misunderstanding."

Could a decision restricting the speech of tens of thousands of compounders have prevented the outbreak? Greenhouse asks, and implies an answer, but doesn't pull the trigger.

I will: No. There is no evidence that the New England Compounding Center's (NECC) advertising had any kind of connection with the outbreak. Contra many media reports, the Food and Drug Administration (FDA) has the authority to inspect, investigate, and penalize compounders pre- and post-Thompson v. Western States. So do state agencies that oversee the licensing of compounding pharmacies.

The Massachusetts Department of Health investigated (and decided not to reprimand) the NECC after a patient who had received an injection from the facility died in 2004 after contracting meningitis. The FDA, which knew about the investigation, decided not to act either.

The commercial speech doctrine merely requires that the government present actual evidence that regulations restricting truthful speech will advance a public interest—rather than just asserting it. That hardly undermines the government's ability to pass and enforce legitimate public health and safety measures.

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  1. I don’t know enough food and drug law to presume to know whether a Supreme Court decision the other way might have prevented the current medical and regulatory crisis.

    say it isn’t so.

    is there a chance an anti-advertising reg was put in there by drug manufacturer lobbyists to stifle their competition?

  2. It’s an extremely fucked up world in which the government must show that restricting speech is a necessary means of acheiving a goal, but it need only show that compelling an actual activity is a convenient means. One would think that compulsory activity is a worse infringement on liberty than mere censorship.

    Or, given Robert’s ruling, you can penalize people for disobeying orders (as long as it’s convenient) but you can’t penalize them for talking (unless it’s necessary).

    In other words, you can force someone to do something because it’s convenient, but you can’t stop them from bitching about it unless it’s necessary, I guess.

    1. If you can stop people from talking about something, it makes it really easy to compel/prevent them from doing it.

  3. Hmmm. I never even thought about it liek that.

    http://www.anon-rule.tk

  4. The notion that the First Amendment protects the advertising of goods and services, although familiar today, is not of ancient lineage,

    Actually, it is. The 1A contains no exception for “commercial speech, so the idea that it protects commercial speech goes way back.

    Its the exception for commercial speech that is the (relative) judicial innovation, as is the limitation on the exception. SCOTUS first looked at the issue (and, predictably, sided with the State) in 1942. The Court didn’t even bother to give any reasons, just said it was clear the state could regulate advertising.

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