Letter to Commissioner Hamburg

Letter

Today, at St. Luke's Hospital in Cornwall, U.S. Senator Charles E. Schumer was joined by hospital CEO Allan Atzrott, doctors and nurses as he called for a nationwide plan to combat the alarming trend in New York and across the nation of infants being born addicted to prescription painkillers or other opiates, known as Neonatal Abstinence Syndrome (NAS). According to a recent study published in the Journal of the American Medical Association (JAMA), approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS, roughly one infant born with the syndrome every hour. In previous years, only a handful of babies were born addicted to painkillers -- now that number has skyrocketed in Orange County and across New York. At St. Luke's Cornwall, the number of babies born with NAS has increased over 300% in the last decade. According to a study conducted by St. Luke's Cornwall in Newburgh, doctors in this hospital saw about 7 babies born with NAS in 2000 to 2001. In 2010 to 2011, that number rose to about 24 cases. This growing trend is apparent in other hospitals across Orange County, and is no reflection of the quality of hospital care, but rather of increased maternal opiate use. Schumer highlighted that St. Luke's Cornwall provides excellent care to its patients, particularly pregnant mothers whose infants suffer from NAS.

Schumer's three-point plan includes: (1) calling on the Food and Drug Administration (FDA) to provide clear labels so that women and doctors know the potential dangers of their medication; (2) pushing the Substance Abuse and Mental Health Services Administration (SAMHSA) to educate doctors so that they're better able to identify the symptoms of prescription drug abuse and treat babies who are born with an addiction; and (3) calling on the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to conduct more research that will help future mothers avoid addiction.

"About one baby per hour is born addicted to prescription drugs, and we must act now to reduce that alarming statistic and prevent this growing trend from spiraling completely out of control in Orange County," said Schumer. "Neonatal Abstinence Syndrome can lead to a number of disturbing health problems in children, such as low birth weight, birth defects and even long-term impairments in the way children learn. Hudson Valley hospitals, like St. Luke's Cornwall, provide excellent care but have not escaped this growing trend, with approximately the same number of infants born addicted to painkillers in a month than the hospitals used to experience in a year. That is why I'm unveiling a three-point plan that calls on the FDA to provide clear labels so that pregnant women know the potential dangers of their medication, pushes SAMHSA to educate doctors to better identify and treat babies born with NAS, and urges NIH and the CDC to do more research to fill what is currently a gaping hole in public knowledge about NAS. Neonatal Abstinence Syndrome is a preventable condition that is harming our children in Orange County, and I will fight tooth and nail to get this comprehensive plan into action."

Senator Schumer was joined by doctors and nurses from the neonatal unit at St. Luke's Cornwall as he outlined his three-point plan to help combat the increasing occurrence of Neonatal Abstinence Syndrome. The JAMA study comes on the heels of an epidemic of prescription drug abuse in New York and across the country. Hudson Valley has especially been hit hard. While Orange County places in the middle third among New York counties for prescription rate, neighboring Sullivan and Ulster counties stand out among the top ten counties in the state affected by drug abuse. In Westchester alone, prescriptions increased 31 percent for oxycodone and 25 percent for zolpidem (Ambien) between 2008 and 2010, according to the New York Attorney General's Office.

NAS is the withdrawal response that occurs when an infant is exposed in utero to maternal drugs of addiction, and is characterized by irritability, tremors, hypertonicity, vomiting, and diarrhea. Although there are few controlled trials in drug therapy of infants with NAS, opiates have been proven to be effective in the management of infants with NAS following withdrawal from methadone or other opioid agents. Schumer noted the devastating impact that NAS has on babies and their development. Drug exposure in utero has been shown to reduce the birth weight and head circumference of the affected infant. There are also long-term cognitive and behavioral problems in infants with NAS. Beyond the devastating personal toll, the study showed that the public cost of NAS is growing exponentially. In 2000, total hospital charges associated with NAS amounted to $190 million; by 2009, they had risen to $720 million, and about three quarters of these costs are carried by Medicaid.

First, Schumer is calling on the U.S. Food and Drug Administration (FDA) to finalize a 2008 rule that made much-needed revisions to prescription drug labeling for pregnant women using all prescription drugs. The Rule has not been finalized. The FDA's 2008 Proposed Rule on Requirements for Pregnancy and Lactation Labeling is designed to facilitate informed counseling about the prescribing of medicines for women who are pregnant, breastfeeding, or of childbearing potential. Schumer noted in his letter to the FDA that it is crucial to do everything possible to combat NAS, and the long overdue finalization of this rule would play an important role by helping pregnant women and their health care providers to avoid medications that may increase the risk of dependence during pregnancy. Schumer also noted this work could help addicted pregnant women to seek medical care that will reduce the risk of NAS.

Second, Schumer called on the Substance Abuse and Mental Health Services Administration (SAMHSA) to ensure that doctors receive the information they need to properly identify and treat cases of babies born with an addiction, and for the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to ramp up research efforts. SAMSHA's Center for Substance Abuse Treatment (CSAT) plays a critical rule in the fight against prescription drug abuse, and Schumer is urging the CSAT to work to find ways of increasing knowledge about treatment of opioid-addicted pregnant women to minimize damage to both mother and child. Under the Data Addiction Treatment Act of 2000, qualifying physicians are entitled to receive a waiver to practice medication-assisted opioid therapy, and Schumer urged SAMHSA to do more to encourage physicians to sign up for this important component of addiction treatment that could greatly help with the treatment of addicted pregnant women.

Finally, Schumer urged the NIH and CDC to extend and expand their research into NAS. While the CDC has flagged prescription-painkiller abuse as a major health threat to pregnant mothers and their children, Schumer highlighted a chronic information deficit involving NAS. Exposure to painkillers in utero can have a devastating impact on babies in the short and long-term, and Schumer is urging for more research to increase awareness of this issue and to allow health providers and officials to develop powerful plans to combat this growing trend.

Schumer sent an initial letter to the FDA regarding this issue in the spring of 2012. However, Senator Schumer is not satisfied with the FDA's response, as it did not mention the issue of prescription drug abuse or addiction in relation to pregnant mothers. While the FDA is clearly doing significant work in ensuring the safety of pregnant women, such as research into whether the flu vaccine hurts pregnant mothers, Schumer is urging the FDA to focus on opioids and drug abuse. Schumer reiterates the significance of the growing trends of maternal opiate use.

A copy of Senator Schumer's letter appears below:

Dear Commissioner Hamburg:

Thank you for your response to my letter regarding the importance of finalizing the May 29, 2008 Proposed Rule on Requirements for Pregnancy and Lactation Labeling. While the letter was informative about the role of the Food and Drug Administration (FDA) in protecting the health of mothers from various factors including influenza, it did not adequately discuss the role of the FDA in protecting infants and mothers from the often disastrous effects of opioid drug use. I respectfully request that the FDA address the questions and concerns relayed in this letter.

My staff recently attended a briefing held by the Office of National Drug Control Policy in which experts from universities across the county along with staff from multiple federal agencies provided information regarding the dangers of neglecting pregnant women and infants that are found to be addicted to opioids. These experts believe that more information is required to understand the full ramifications of prescription drug addicted mothers and infants, but with early intervention, it is possible to eliminate many of the long-term effects. As the FDA has an oversight role in the approval of drugs, I believe the FDA must take the lead in studying this dangerous issue.

As you know, from information obtained by hospital billing data, the Agency for Healthcare Research and Quality, and a University of Michigan study, we have seen that the incidence of Neonatal Abstinence Syndrome (NAS) has grown 3 fold from 2000 to 2009. This equates to approximately one baby being born in the United States with NAS every hour. In the same time frame we have seen maternal opiate use and abuse grow 5 fold. Due to these alarming trends we know that a coordinated effort is needed to address this problem. I ask that the FDA work with the relevant stake holders to address the issues and outcomes associated with both pregnant women taking properly prescribed medication or opioids and pregnant women who are addicted or are abusing these same medications. Please also address if the FDA requires further authority to regulate the prescription drugs which may have harmful effects on infants.

I am aware that the FDA is holding an upcoming meeting of the Drug Safety and Risk Management Advisory Committee (DSaRM) and I hope these concerns are brought up and discussed here. I appreciate your consideration and attention to this important matter and look forward to your response. Please feel free to contact my staff should you have any questions.

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