Letter to The Honorable Margaret Hamburg, M.D. Commissioner Food and Drug Administration

Letter

Today, joined by doctors and nurses at Sisters of Charity Hospital, U.S. Senator Charles E. Schumer unveiled his three-point plan to combat the alarming trend in Buffalo and nationwide of infants being born addicted to prescription painkillers, known as Neonatal Abstinence Syndrome (NAS). In previous years, only a handful of babies were born addicted to painkillers -- now that number has skyrocketed in Buffalo and around the country. Some Western New York hospitals note that they now have more babies born addicted to painkillers in a month than used to occur in an entire year. Nationwide, it is estimated that one baby per-hour is born addicted to painkillers.

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 the medication they're taking; (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 (3) calling on the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to do 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 Western New York," 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. Western New York hospitals 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 Western New York, and I will fight tooth and nail to get this comprehensive plan into action."

Senator Schumer was joined by Dr. Kamal Singhal, a neonatologist, and nurses from the neonatal unit at Sisters of Charity Hospital as he outlined his three-point plan to help combat the increasing occurrence of Neonatal Abstinence Syndrome. Schumer highlighted that the number of babies born addicted to prescription opiates has nearly tripled in the past decade, according to the latest data. The research, which was the first national survey of its kind, and was published in the Journal of the American Medical Association in May, revealed that approximately 3.4 of every 1,000 infants born in 2009 suffered from NAS -- amounting to about one infant born with the syndrome every hour.

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 National Institute of Health and the Center for Disease Control 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 develop powerful plans to combat this growing trend.

A copy of Schumer's letters appears below:

June 11, 2012

The Honorable Margaret Hamburg, M.D.
Commissioner
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

Dear Commissioner Hamburg:

I write today to urge the Food and Drug Administration (FDA) to finalize the May 29, 2008 Proposed Rule on Requirements for Pregnancy and Lactation Labeling. A 2011 study of all medications approved by FDA from 1980 through 2010 found that 91% of the medications approved for use by adults had insufficient data to determine the risk of using the medication during pregnancy. Data suggest that women receive an average of 3 to 5 prescriptions during each pregnancy and that 64% of pregnant women use at least 1 prescription drug.

While FDA is to be applauded for proposing much needed changes to the current pregnancy labeling system of categories A, B, C, D, and X, I am concerned that four years have passed and still the rule is not final.

I am particularly concerned about the delay because of recent published research that has found that every hour one baby is born suffering from drug withdrawal. A study published in May in the Journal of the American Medical Association estimated that in 2009 more than 13,000 babies were born with neonatal abstinence syndrome (NAS), a withdrawal syndrome that occurs in some babies after being exposed to a class of opiates, while in utero.

As you know, prescription drug abuse is a terrible epidemic in the U.S. and I believe we need to do everything possible to combat this issue, including helping pregnant women and their health care providers to avoid medications that may increase risk of dependence during pregnancy. It is also critically important to help addicted pregnant women to seek medical care that will reduce the risk of NAS.

Thank you for your consideration.

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