Category: Public Health

Regulating Tobacco Standards: An Easy Fix in a Scientifically Uncertain Field

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Last week, the New England Journal of Medicine published a study finding that smokers using reduced nicotine cigarettes smoked 30% fewer cigarettes and had reduced cravings at the end of the study compared to smokers using standard cigarettes. The lower-nicotine cigarettes had 0.4 mg of nicotine/gram compared to 15.8 mg of nicotine/gram for the standard cigarettes. Commentators were quick to point out that such studies could provide the evidence FDA needs to establish new nicotine standards for combustible cigarettes.

FDA has explicit authority from Congress to set low nicotine standards for cigarettes. The Family Smoking Prevent and Tobacco Control Act (FSPTCA) allows FDA to set “tobacco product standards,” including provisions for “nicotine yields of the product” where such standards are “appropriate for the protection of public health.” With a mountain of evidence showing that combustible cigarette addiction can lead to cancer, heart disease, and death, FDA should have no problem proving that nicotine standards for combustible cigarettes are appropriate.

FDA may have a harder task trying to show that nicotine reduction standards for other tobacco products are “appropriate for the protection of public health.” As one commentator noted, if the nicotine in combustible cigarettes declines, addicted smokers might switch to other nicotine-containing products, including smokeless-tobacco products, e-cigarettes, and e-pipes. Currently, no study has conclusively shown that smokeless tobacco products are safe or unsafe. Some studies suggest that smokeless tobacco products may lead to smoking later in life, while other studies show that smokeless tobacco may be helpful for smokers hoping to quit.

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For Vaccines, Public Health Protection Trumps Religious Freedom (Again)

Ross D. Silverman Leave a comment

This week, the Supreme Court appropriately declined to hear an appeal of a 2nd Circuit decision upholding the right of the state to require vaccination as a condition of enrollment in public schools, and to exclude exempted children from attending school during an infectious disease outbreak.

Tony Yang and I wrote in the New England Journal of Medicine about the January 2015 Federal appeals court decision (Phillips v. City of New York). As we wrote at the time:

Under the Constitution, states have police power to protect the public’s health, welfare, and safety. A long-standing use of this authority is to protect communities from risks related to vaccine-preventable illnesses. In addition, when an infectious-disease outbreak occurs, states may use their police power to interrupt further transmission of the disease by restricting the movement of individuals. All states have incorporated this concept of social distancing into their school immunization laws. Schools can prohibit an unvaccinated child, who is more susceptible to acquiring highly infectious vaccine-preventable illness and more likely to become a carrier and vector for it, from coming to school until the danger subsides. Such measures, coupled with ready availability of vaccines, reduce the potential spread of serious disease in a vulnerable and tightly packed community. Read More

RFRA Jumps The Shark: The 8th Circuit Strikes Down the Contraception Accommodation (Part 2)

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Lego_SharkJump
Flickr/Creative Commons – Bill Ward

By Gregory M. Lipper

Thomas Jefferson famously said that “[i]t does me no injury for my neighbour to say there are twenty gods, or no god. It neither picks my pocket nor breaks my leg.” Note what Jefferson did not say: “my neighbor is entitled to pick my pocket and break my leg, so long as the government can refill my pocket and pay for a cast on my leg.”

But the latter formulation seemed to influence last week’s Eighth Circuit ruling that the Religious Freedom Restoration Act (RFRA) bars the government from implementing an accommodation for employers with religious objections to including contraception in their health plans. In my previous post, I explained why the Eighth Circuit reduced RFRA’s substantial-burden requirement to a mere formality, potentially subjecting any and every federal law or regulation to strict scrutiny. Once things get to strict scrutiny, the Eighth Circuit goes even further, suggesting that a federal regulation cannot be sustained if the government could, in theory, provide the benefit or service itself.

The Eighth Circuit first applied this approach to the process by which employers obtain the religious exemption. Under the current rules, an objecting organization need only send a written notice to the government and identify its insurance provider or third-party administrator; the government then works with the insurance provider or third-party administrator to arrange for the employees to receive the contraceptive coverage to which they are entitled by law.

The Eighth Circuit, however, reasoned that there is a less-restrictive alternative to requiring this information, since the government could identify the necessary insurance providers and third-party administrators on its own—well, maybe: “Even if the [third-party administrators] are not known, the government has not shown at this stage of the proceedings that the inconvenience of identifying the [third-party administrators] likely would create an administrative problem of sufficient magnitude to make its entire scheme unworkable.” According to the Eighth Circuit, then, no disclosure requirement can be sustained unless the government can prove that it would be unable to discover the information after its own investigation.

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I Concur with the Dissent (or, More on Little Sisters)

Holly Fernandez Lynch 1 Comment

On September 3, the 10th Circuit declined to rehear en banc several challenges to the contraceptives coverage mandate filed by non-profit organizations, including Little Sisters of the Poor. As SCOTUSBlog explains, these organizations had not themselves asked for en banc review, having already moved on to SCOTUS, but the judges have the option of calling for a vote themselves, which one or more of them must have done.  The vote came down 7-5 in favor of refusal, with the dissenting judges (i.e., those who wanted en banc review) issuing an explanation of their position.  On this issue, I concur with the dissent.  But I still don’t think the objecting non-profits should be off the hook.

When it comes to the contraceptives coverage mandate, non-profits, and now certain for-profits, are accommodated such that they may be relieved of the responsibility to contract, arrange, pay, or refer for contraceptives coverage if they notify the government or their health insurer of their objection to doing so, such that their insurer (or third party administrator of self-insured plans) can provide free contraceptives to their employees, at no cost to and without the involvement of the employer (all further explained here by Greg Lipper).  However, many organizations continue to argue that the accommodation fails to relieve them of complicity in providing contraceptives against their religious beliefs.  They want flat out exemption from the mandate. Read More

HHS’ Proposed Anti-Discrimination Regulations: Protective But Not Protective Enough

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By Elizabeth Guo

Last week, the Department of Health and Human Services (HHS) Office of Civil Rights (OCR) released a proposed rule implementing section 1557 of the Affordable Care Act (ACA). Section 1557 applies the Rehabilitation Act of 1973 to the ACA so that a covered entity cannot discriminate against an individual on the basis of a disability in any health program or activity. The proposed rule clarified how OCR intended to enforce and interpret section 1557’s nondiscrimination provision.

As Timothy Jost and other commentators have noted, the government’s proposed interpretation of section 1557 significantly expands the number of health entities that need to meet the Rehabilitation Act’s nondiscrimination requirements. The regulation proposes to encompass all entities that operate a health program or activity, any part of which receives federal financial assistance. The regulation then broadly interprets “federal financial assistance” to include “subsidies and contracts of insurance.” Thus, an insurer receiving premium tax credits or cost-sharing reduction payments through participating in a health insurance Marketplace would need to ensure that all its health plans meet the Rehabilitation Act’s nondiscrimination requirements, regardless of whether the plans are sold through the Marketplace, outside the Marketplace, or through an employee benefit plan. This broad interpretation means that the Rehabilitation Act’s nondiscrimination provisions will now apply to a number of previously excluded plans.

Expanding the number of plans needing to meet section 1557’s nondiscrimination requirements will provide greater protection to more individuals with disabilities. In the United States, the Rehabilitation Act and the Americans with Disabilities Act (ADA) prohibit discrimination against individuals with disabilities. Both acts protect disabled individuals, but courts have consistently interpreted only the Rehabilitation Act as prohibiting insurers from designing their health plans to discriminate against individuals with disabilities. On the other hand, courts have held that the ADA provides a safe harbor for insurers when designing their benefit plans. Thus, some insurers under the ADA may be able to exclude all drugs treating HIV/AIDS from their formulary or place all drugs treating HIV/AIDS on the highest cost-sharing tier, benefit designs that the Rehabilitation Act would likely prohibit. See also Kelsey Berry’s post on this topic.  Read More

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

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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

Little Sisters: Cato Institute Targets the Affordable Care Act—Yet Again

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Flickr Creative Commons/UCI UC Irvine

By Gregory M. Lipper

Fresh off its unsuccessful attempt to gut the Affordable Care Act in King v. Burwell, the Cato Institute is back for more. This time, Cato has filed an amicus brief in support of Supreme Court review in Little Sisters of the Poor Home for the Aged v. Burwell. This is one of the many, many (many) challenges brought under the Religious Freedom Restoration Act (RFRA) by nonprofit organizations to an accommodation, offered by the Department of Health and Human Services (HHS), exempting religious nonprofits from providing contraceptive coverage to their employees. To take advantage of the accommodation, nonprofits need only provide written notice to the government of their objection and the name of their insurance provider or plan administrator. At that point, the government arranges for the nonprofit organization’s insurance company or plan administrator to provide the coverage at no cost to the nonprofit or its employees.

These RFRA challenges to the nonprofit accommodation have been rejected by all seven federal appeals courts to address them. But in this brief backing the challenge by Little Sisters, Cato asks the Supreme Court to dodge the RFRA question entirely, claiming that the case “can be resolved without further engaging in the delicate analysis required by the Religious Freedom Restoration Act.” Instead, Cato makes the following argument: (1) in light of King v. Burwell’s statements about agency deference, HHS had no authority to offer religious accommodations to its own regulations implementing the Affordable Care Act, and (2) without a religious accommodation, the contraceptive coverage requirement is unenforceable against nonprofit organizations with religious objections.

Cato seeks—in the name of religious liberty!—to prevent regulatory agencies from granting accommodations to entities with religious objections to regulations, and then argues that the absence of religious accommodation makes the underlying regulations unenforceable against religious objectors. Cato’s curious argument suffers from two serious flaws.

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DCIS Study Amplifies Questions and Demand for Answers

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By Dalia Deak

This week, a JAMA Oncology article made a splash when it intensified discussion around what ductal carcinoma in situ (DCIS) should be considered – cancer, precursor, or risk factor – and whether current treatment approaches have been effective. The New York Times, The Guardian, and others have picked up the story, and readers have reacted extensively, only amplifying a demand for answers to questions raised.

Often called Stage 0 breast cancer, DCIS is considered to be abnormal cells that are confined inside the milk ducts and, as such, are not considered invasive. Because of the increased risk associated with DCIS, many women who are found to have DCIS (a growing number considering the frequency of and improvements in mammography) undergo lumpectomies or mastectomies often accompanied by radiation therapy. Read More

Call for Abstracts! 2016 Annual Conference: Big Data, Health Law, and Bioethics

The Petrie-Flom Center Staff Leave a comment

Close-up of fiber optic cables

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2016 annual conference, entitled: “Big Data, Health Law, and Bioethics.”  This year’s conference is organized in collaboration with the Berkman Center for Internet and Society at Harvard University and the Health Ethics and Policy Lab, University of Zurich.

Conference Description

“Big Data” is a phrase that has been used pervasively by the media and the lay public in the last several years. While many definitions are possible, the common denominator seems to include the “three V’s” – Volume (vast amounts of data), Variety (significant heterogeneity in the type of data available in the set), and Velocity (speed at which a data scientist or user can access and analyze the data). Read More

NOW AVAILABLE: FDA in the 21st Century: Get 30% Off When You Order through the Press!

The Petrie-Flom Center Staff Leave a comment

lync17118_frontJust out from Columbia University Press, FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies! This volume, co-edited by Petrie-Flom Center Executive Director Holly Fernandez Lynch and Faculty Director I. Glenn Cohen, stems from the Center’s 2013 annual conference, which brought together leading experts from academia, government, and private industry to evaluate the FDA and to begin charting a course for the agency’s future.

Use promo code FDA21 and save 30% if you order now at the Columbia University Press website!

And join us at Harvard Law School on October 28 for a book launch and panel discussion featuring editors Holly Fernandez Lynch and Glenn Cohen!