Refrain From Implementing Neonatal Opioid Withdrawal Syndrome (NOWS)- Related Labeling Changes
cder 2013-8430 citizen petition NAPW neonatal opioid withdrawal syndrome NOWS
2014-02-11 2014-02-11
FDA-2013-P-1288-0005 FDA-2013-P-1288-0004
05:00:00 05:00:00
https://api.regulations.gov/v4/comments/FDA-2013-P-1288-0005 https://api.regulations.gov/v4/comments/FDA-2013-P-1288-0004
Anonymous Anonymous
Anonymous Anonymous
Petitioners comments are well-received and should be closely reviewed by the FDA. Pregnant women are particularly vulnerable and have suffered greatly when policy has been built on scientific evidence that was insufficiently scrutinized (e.g. pregnant women have been arrested and incarcerated for testing positive for illicit substances during medical care in many parts of the United States, generally based on concerns of the harms of that substance use on the developing fetus without a strong scientific consensus). The petitioners raise very serious concerns about the language used in the planned labeling changes as they relate to NOWS, including the use of the term lifethreatening and language that could easily be used by providers, policymakers, and law enforcement and judicial agencies to restrict access to opioid agonist maintenance treatment or to punish patients receiving such therapy. At this stage, we rely on agonist maintenance therapy as the gold standard for treatment of opioid use disorders, particularly among pregnant women. It is critical that the labeling changes account for this by:1) emphasizing the essential role of agonist maintenance treatment among pregnant women and2) adopting more limited and evidence-based language regarding the nature and risks of NOWS.I am a board-certified internist and infectious disease specialist as well as a buprenorphine provider. I am an NIH-funded substance use investigator directing clinical trials into pharmacologic and behavioral therapies for substance use as well as studies of programmatic and structural changes to clinical care to minimize the medical sequelae of substance use (including efforts to improve opioid stewardship and minimize opioid-related mortality). The American College of Obstetricians and Gynecologists strongly opposes the black box warning on opioid medications directed toward pregnant women.  Opioid medications are the safest choice for use by pregnant women who experience moderate to severe pain.  In addition, women who are pregnant and dependent on opioid medications put their fetus in great danger if withdrawn from these medications during their pregnancy.  Neonatal Abstinence Syndrome, which may result from maternal opioid use, is a fully treatable condition without subsequent patho-physiology.  The warning proposed by the FDA concerning infant death has not been substantiated.  Thank you.