How the FDA Produces Knowledge (and Is Not So Weird)

Credit: SalFalko

The Federal government has wrested billions of dollars from the drug and device industry in settlements of claims that the companies broke the law by promoting their products “off-label” for uses not approved by the FDA.  In response, companies have asserted that promotions are a form of speech, protected by the First Amendment. Speech regulations are especially worrisome when motivated by paternalism.  This argument has received some traction in the courts, and is now getting a favorable look by the Trump administration.

I have argued (here, here, and here) that this law is not actually a speech regulation.  Nor is it paternalistic.  Instead, it is simply a vanilla regulation of a behavior (shipment of product in interstate commerce), which depends on various sources of evidence (including speech) as revealing whether the actor has an illicit intent (an unapproved use of the product).  The pre-market approval system, which requires that companies prove safety and efficacy for all intended uses, solves a collective action problem to produce information as a public good.  This is our key social mechanism for producing knowledge about safety and efficacy.  If this law is unconstitutional in the off-label context, the entire pre-market approval system would seem to be as well.

In a new piece out on SSRN, my physician co-author Victor Laurion develops the example of the drug Seroquel XR, to show how a federal prosecution for off-label promotion caused the company to perform scientific research on two new indications (general anxiety disorder and major depression).  A detailed discussion of the regulatory record shows how physician prescribing was improved by this public information, regardless of whether the FDA approved the new indication.  In this way, the FDA protects the liberty of physicians and patients to try drugs for new uses, even while holding companies to the proof of any uses that they actually intend.  The fact that the company’s intention is shown by speech evidence is immaterial. Read More

Is it legal for Trump to punish health insurers that do not support repeal of Obamacare?

By Christopher Robertson

In a recent story about how the health insurance marketplaces are being destabilized by the Trump administration’s vacillation, the LA Times reports:

At one recent meeting, Seema Verma, whom Trump picked to oversee the federal Medicare and Medicaid programs, stunned insurance industry officials by suggesting a bargain: The administration would fund the CSRs if insurers supported the House Republican bill to repeal the Affordable Care Act.

For what its worth, the Trump administration denied that she had done so.  But if she did, is that legal?  Can politicians actually offer to give money from the Federal Treasury to companies in exchange for their political support (or withhold it for lack of that support)?  If Ms. Verma was corruptly offering a “quid pro quo” exchange (as TalkingPointsMemo says), that would fit the statutory definition of the crime of bribery, as I discuss in a 2016 paper, The Appearance and Reality of Quid Pro Quo Corruption. However, this case also implicates the First Amendment rights of the insurance companies to support or oppose the Obamacare repeal. Read More

Vaccinate Your Children (Says a Federal Judge)

Flickr Creative Commons-Dan Hatton
Flickr Creative Commons-Dan Hatton

By Gregory M. Lipper

After nearly four years fighting about whether and when employers may exclude contraceptive coverage from employee health plans (and even block others from providing that coverage), it’s perhaps refreshing to see less controversial cases. And few healthcare-exemption cases are less controversial than those brought by parents who object to vaccinating their children. Although the challenged laws are objectively more intrusive than the contraceptive regulations—vaccination laws require parents to get the offending treatment injected into their children—courts thus far have correctly dismissed these challenges with little fanfare.

This dynamic surfaced again in a recent federal trial-court decision in California, in which the court dismissed a federal and state constitutional challenge to California legislation repealing the “personal belief exemption” to requirements that those entering schools and child-care facilities get vaccinated against diseases—including diphtheria, measles, mumps, rubella, and other dreadful ailments. The court acknowledged that eliminating the personal-belief exemption “raises principled and spirited religious and conscientious objections by genuinely caring parents and concerned citizens,” but stated that “the wisdom of the Legislature’s decision is not for this Court to decide.” Because the legislature decided to scrap the personal-belief exemption, California now exempts only those children (1) with actual medical reasons for avoiding the vaccination, (2) who are home schooled, or (3) who qualify for an Individualized Education Program under federal disabilty law. That’s a much more limited and manageable group of exemptees.

Although quite a relief for those seeking to minimize gratuitous suffering from preventable diseases, the court’s decision implicates several knotty legal issues and is worth exploring further.

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Recent Developments in Off-Label Promotion

By Chris Robertson

July has been a busy month for those following the controversy around off-label promotion of drugs and devices.  As many on this blog know, federal law requires that prior to marketing any drug or device, companies must prove to the FDA’s satisfaction that it is safe and effective for all intended uses.  If the company reveals that it intends unapproved uses,  sales of the drug or device are illegal.  Nonetheless, physicians can prescribe “off-label,” and companies are free to sell for those known-but-not-intended purposes.

This carefully-wrought policy may seem convoluted, but it serves important epistemic and economic purposes, as I have argued elsewhere.  This month, I have a new draft paper on SSRN, assessing recent assertions of a First Amendment right to promote for uses not approved by the FDA, and consider whether such a right would be equally applicable to drugs that have no FDA-approved label at all. I worry that the entire pre-market approval regime may be at stake. Feedback on that intentionally-provocative analysis is quite welcome.

On Wednesday, two medical device company executives, were convicted of promoting a product “to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open.”  The prosecutors thought the case was particularly egregious, because the company had intended the broader use to deliver medicine all along, but sought to mislead the FDA, denying it the chance review the safety and efficacy of the real intended use.  The jury instructions and verdict form  are particularly interesting, to see how the government’s trial strategy avoids the holding of a Second Circuit case of Caronia, which overturned a conviction on First Amendment grounds.  I’ll return with some analysis later. Read More

Religion or Women?

In response to the religious objections levied against the contraceptives coverage mandate at issue in Hobby Lobby, Zubik, and gobs of other cases, many have argued that this was really a matter of subjugating women – not about religion per se.  Well, now we have a test case: Vermont’s governor just signed into law a requirement that public and private health insurance cover vasectomies without copays and deductibles. There won’t be the same arguments about abortifacients here, but many religious employers should object just the same, if they’re being consistent. Now let’s watch and see…

SCOTUS and More Surprises on Zubik

After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case.  The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.

SCOTUS has pulled a few tricks out of its hat to avoid that possibility.  First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire).  The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept.  Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.

So what does that mean?  In my view, count it as a win for the government.  Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now.  Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden.  And SCOTUS hasn’t said there is.

What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision.  The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president.  The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits.  Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.

The Curious Case Of The Docs Versus The Glocks: Firearms, The First Amendment, And Physician Speech

By Wendy Parmet

This new post by Wendy Parmet appears on the Health Affairs Blog as part of a series stemming from the Fourth Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 29, 2016.

On February 3, 2016 the full U.S. Court of Appeals for the 11th Circuit agreed to rehear the appeal inWollschlaeger v. Florida, commonly known as the case of the “docs versus the glocks.” Wollschlaegerconcerns a Florida law that bars physicians from routinely asking their patients whether they have guns or store them safely. In agreeing to rehear the appeal, the full court vacated a decision issued last December by a three-judge panel which had replaced two of its own prior opinions. Each of the panel’s three decisions upheld the law, and each raised serious questions about the ability of health professionals to provide their patients with relevant health information.

Public health professionals have long viewed gun safety as a major public health problem. Likewise, many physicians believe that good primary care includes questioning and counseling patients, especially those with children, about firearm safety, just as they talk to patients about seatbelts, cigarettes, and the need to exercise. […]

Read the full post here.

Abortion Derangement Syndrome, Missouri Edition

Flickr/Creative Commons—Nicola
Flickr/Creative Commons—Nicola

By Gregory M. Lipper

Although the biggest abortion-related news last week came from the U.S. Supreme Court, a Missouri state senator (turned Attorney General candidate) took the prize for most bizarre.

Senator Kurt Schaefer—chairman of the Missouri Senate’s interim “Committee on the Sanctity of Life”—wrote a stern letter to the University of Missouri; he suggested that state law prohibited a Ph.D student from researching the effects of Missouri’s mandatory 72-hour waiting period for women who want to have an abortion. The law he cited provides, “It shall be unlawful for any public funds to be expended for the purpose of performing or assisting an abortion, not necessary to save the life of the mother, or for the purpose of encouraging or counseling a woman to have an abortion not necessary to save her life.”

This farfetched attempt to censor academic research on the effects of government policy raises a pair of legal issues (and one psychological observation…).

First, Senator Schaefer’s interpretation of the statute is, to put it mildly, a stretch. The student isn’t going to be “performing or assisting an abortion”; she’s going to be studying abortion—more precisely, the 72 hours between when a woman seeks an abortion and is allowed to have an abortion.

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A Circuit Split on Contraceptives Coverage

Perhaps foreshadowed by the dissent in the 10th Circuit that I wrote about here, the 8th Circuit has now officially launched a circuit split regarding the legal validity of the accommodation that allows modified compliance/objection to the contraceptives coverage mandate.  Unlike the seven other circuits to have considered the question since Hobby Lobby, the 8th Circuit yesterday issued opinions upholding preliminary injunctions in two cases (here and here), thereby preventing the mandate+accommodation from being enforced against the objecting non-profits.

First, the 8th Circuit determined that the accommodation still substantially burdens objectors’ religious beliefs because it imposes significant financial penalties if they refuse to comply with a requirement that they view as violative of those religious beliefs. As I explained previously, I do think the court was right to focus on the monetary consequences of objection, rather than assuming that merely filing the required paperwork for an accommodation does not or cannot actually make objectors complicit in the way they claim it does.

Like SCOTUS in Hobby Lobby, the 8th Circuit then went on to assume that the contraceptives coverage mandate advances a compelling government interest, which is the next step in the analysis under the Religious Freedom Restoration Act once the substantial burden test is met.  So far, so good.  But that’s the end of my agreement.

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Government Regulation of Commercial Speech: is Amarin Pharma’s Breakout Moment?

By Ryan Abbott

Government regulation of off-label promotion by pharmaceutical companies is now an important First Amendment issue. The Food and Drug Administration (FDA) has historically restricted truthful and non-misleading speech by pharmaceutical companies under the Food, Drug and Cosmetic Act (FDCA). The FDCA prohibits introducing “misbranded” products into interstate commerce. The FDA has interpreted this to prohibit pharmaceutical companies recommending uses not already approved by the agency (these uses appear in a drug’s labeling). Drugs promoted for unapproved uses may also be considered “new” drugs which require FDA approval. Pharmaceutical companies can also face liability under the False Claims Act for off-label promotion.

United States v. Caronia was the first time the FDCA’s misbranding provisions were successfully challenged under the First Amendment. In 2012, the Second Circuit held that the FDA’s regulations failed the test for commercial speech announced in Central Hudson. Namely, the Court held that restricting truthful speech did not directly advance a government interest (rather, the regulations paternalistically prevented dissemination of truthful information), and the Court held that the FDA’s regulations were more extensive than necessary. The Court did not even analyze the regulations under the test announced in Sorrell v. IMS Health, decided by the Supreme Court in 2011, which held that heightened scrutiny was warranted where restrictions are content- and speaker-based. The FDA did not seek en banc review or writ of certiorari.

Almost immediately, the case was heralded as a landmark decision that would have a profound impact on drug regulation. However, that has yet to occur. Since the case was decided the FDA has already generated large settlements with companies like Amgen for violating agency regulations on off-label promotion. That may be because of uncertainty regarding Caronia’s reach, and because for large companies a relatively cheap settlement makes more sense than risking felony indictments and exclusion from government programs. For the agency’s part, it has tried to avoid fully vetting constitutional issues surrounding its regulations. The FDA stated after Caronia that the ruling would not alter its enforcement policy. Although, the agency has stated it is developing new guidances concerning off-label promotion.

The newest development in this story came last month in Amarin vs. United States. Read More