Photograph of a gavel and three open books

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

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Zeroing In on “Zero Tolerance” School Discipline Laws

By Alexandra Hess

Exclusionary school discipline (ESD) policies, also known as Zero Tolerance policies, enforce disciplinary measures like suspension, expulsion, or law enforcement referral to address particular student behaviors.

Though it began as part of the Gun-Free Schools Act of 1994, which mandated one-year expulsion for possessing a firearm at school, ESD became more widely adopted over time. Now, the policies apply nationwide to a broad range of behaviors — from damaging property and fighting, to possessing a cell phone or tobacco, as well as behaviors described by subjective terms often undefined in the law, like willful defiance, obscenity, or profanity. Read More

A baby getting vaccinated by a doctor wearing gloves.

The Rockland Ban: The Next Step in the Battle Against Measles

Rockland County, New York’s Executive, Ed Day, issued an emergency declaration last month, banning unvaccinated children from public places. Although this seems like a drastic step, it is the culmination of extensive efforts to stem a large outbreak created by anti-vaccine misinformation. It is also in line with principles of public health.

For months, Rockland county in New York has been battling a large measles outbreak. As of April 2, 2019, the outbreak reached 158 cases. The vast majority of cases – 86 percent – were in minors under the age of 18, and over 50 percent are under six years old. Only 3.8 percent of the victims are fully vaccinated (3.8 percent received two doses of the Measles, Mumps, Rubella vaccine, MMR). And 82.8 percent of cases are known to be unvaccinated. Many of the cases are concentrated in Orthodox Jewish neighborhoods.

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close up of the back of a baby's head while breastfeeding

Toxic Breastmilk: When Substance Abuse Relapse Means Death for Baby

Recently, a nursing mother in Pennsylvania made national headlines when her infant died from ingesting a combination of fatal drugs through breastmilk.  According to the coroner’s report, the infant died from a combination of methadone, methamphetamine, and amphetamine toxicity. The Bucks County District Attorney charged the mother, Samantha Jones, who also has a two-year old child, with criminal homicide. According to published reports, Jones was undergoing Medication Assisted Treatment (MAT) and receiving doses of methadone to treat her addiction to opioid painkillers.

Multiple commentators swiftly voiced opposition to the District Attorney, decrying the criminal charges against Jones, arguing it is “highly problematic” to levy criminal charges against a person undergoing treatment for Substance Use Disorder.

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baby held in mother's hands in lap

US Legislators Take a Scattered Approach to Neonatal Abstinence Syndrome

 By J. Alexander Short

Pennsylvania is the latest state to enact legislation in reaction to the growing impact the opioid epidemic has on infants. Governor Tom Wolf signed H.B. 1232 in June, effectively requiring hospital officials to notify child protective services when children are born affected by the mother’s substance abuse or affected by withdrawal symptoms as a result of prenatal drug exposure.

Such outcomes generally fall within the parameters of neonatal abstinence syndrome (“NAS”), a group of health problems that occur in newborns who were exposed to drugs while in the mother’s womb.  This legislation brings Pennsylvania into full compliance with the 2003 Federal Child Abuse Prevention and Treatment Act.

This legislative response makes sense.

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The Health Imperative: Reunite Migrant Children with their Parents

By Gali Katznelson

Japanese family awaits evacuation 1942
A Japanese family awaits an evacuation bus to an internment camp in 1942. Children who spent time in the camps have high incidence of trauma and health problems, studies have shown. Photo via US National Archives.

Former first lady Laura Bush published an op-ed in the Washington Post where she reminded us that today’s mass detention centers for children whose parents are accused of illegally crossing the border is a public health crisis — one we have seen before.

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a pile of vaccine vials and a needle

Long Overdue: Check Out the Vaccine Resources Library for Expert Witnesses

By Dorit Reiss, Stanley A. Plotkin, Paul A. Offit

A new tactic has emerged in a few recent family law vaccination cases: using arguments created by the anti-vaccine movement.

Lack of familiarity with anti-vaccine claims can trip up even the most qualified expert. But a new resource library at the Vaccine Education Center at the Children’s Hospital of Philadelphia aims to combat anti-vaccine rhetoric and by giving experts the information they need to respond.

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The Notable Absence of Regulating Cannabis in FDA Commissioner Scott Gottlieb’s Keynote Address to FDLI 2018

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Read More

States Tackle Youth Sports Concussions – New Data!

By Benjamin Hartung, JD, Joshua Waimberg, JD, and Nicolas Wilhelm, JD

While brain injuries and studies associated with professional football get the majority of media attention, student athletes, especially young football and soccer players, are also at risk for similar brain injuries. Each year, as many as 300,000 young people suffer from traumatic brain injuries (TBIs), more commonly known as concussions, from playing sports.

State governments have responded to the problem of brain injuries in youth sports by adopting laws aimed at reducing the harm that comes from injuries that occur during team practices or events. Delaware was the first state to pass a regulation relating to youth TBIs in 2008, with Washington State following shortly after in 2009. In the years since, all states have passed youth TBI laws, many modeled after the Washington law, that mandate when student athletes are to be removed from the field, how parents should be notified in the event of a concussion, what training is required of athletic coaches, when a student athlete may “return-to-play,” and who may allow this return to the field. Read More

New data: Baby-Friendly Hospital Laws

The Baby-Friendly Hospital Initiative (BFHI) is a global initiative of UNICEF and the World Health Organization aimed at promoting hospital policies that encourage and support breastfeeding. Baby-Friendly USA, the organization primarily responsibile for implementing BFHI in the United States, has outlined 10 evidence-based practices that hospitals can implement to support breastfeeding — called the 10 Steps to Successful Breastfeeding. These include written breastfeeding policies, staff training, rooming-in, and educating mothers about the benefits and management of breastfeeding.

Several states have enacted statutes or regulations encouraging or requiring hospitals to adopt one or more of these “baby-friendly practices.”

The newest map on LawAtlas.org, which was created and is maintained by ChangeLab Solutions, identifies key features of state laws and regulations regarding recommendations or requirements for hospitals related to any of the 10 Steps to Successful Breastfeeding. It also includes state laws recommending or requiring certain hospital discharge practices related to breastfeeding.

In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices
In 15 of the 18 states with laws laws or regulations that encourage and support breastfeeding initiation and continuation, hospitals must follow one or more baby-friendly practices.

As of October 1, 2016, 18 states had enacted laws or regulations that encourage and support breastfeeding initiation and continuation. In 15 of these states, hospitals must follow one or more baby-friendly practices.

Explore the maps and download the data at LawAtlas.org.