The Food and Drug Administration (FDA) is a regulatory agency of the United States federal government This article describes the scope of work of each of the FDA's major components, and addresses the role of statisticians at FDA


Keywords:

drug regulation;
clinical trials;
medical devices;
safety;
bioassay

Food and Drug Administration (FDA)

Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012

Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 2009 to 2012.

Importance More than 42 000 Americans died of opioid overdoses in 2016, and the fatalities continue to increase. This review analyzes the factors that triggered the opioid crisis and its further evolution, along with the interventions to manage and prevent opioid use disorder (OUD), which are fundamental for curtailing the opioid crisis. Observations Opioid drugs are among the most powerful analgesics but also among the most addictive. The current opioid crisis, initially triggered by overprescription of opioid analgesics, which facilitated their diversion and misuse, has now expanded to heroin and illicit synthetic opioids (fentanyl and its analogues), the potency of which further increases their addictiveness and lethality. Although there are effective medications to treat OUD (methadone hydrochloride, buprenorphine, and naltrexone hydrochloride), these medications are underused, and the risk of relapse is still high. Strategies to expand medication use and treatment retention include greater involvement of health care professionals (including psychiatrists) and approaches to address comorbidities. In particular, the high prevalence of depression and suicidality among patients with OUD, if untreated, contributes to relapse and increases the risk of overdose fatalities. Prevention interventions include screening and early detection of psychiatric disorders, which increase the risk of substance use disorders, including OUD. Conclusions and Relevance Although overprescription of opioid medications triggered the opioid crisis, improving opioid prescription practices for pain management, although important for addressing the opioid crisis, is no longer sufficient. In parallel, strategies to expand access to medication for OUD and improve treatment retention, including a more active involvement of psychiatrists who are optimally trained to address psychiatric comorbidities, are fundamental to preventing fatalities and achieving recovery. Research into new treatments for OUD, models of care for OUD management that include health care, and interventions to prevent OUD may further help resolve the opioid crisis and prevent it from happening again.

Prevention and Treatment of Opioid Misuse and Addiction: A Review.

Intrahepatic cholestasis of pregnancy.

Background The authors investigated nationwide trends in opioid abuse or dependence during pregnancy and assessed the impact on maternal and obstetrical outcomes in the United States. Methods Hospitalizations for delivery were extracted from the Nationwide Inpatient Sample from 1998 to 2011. Temporal trends were assessed and logistic regression was used to examine the associations between maternal opioid abuse or dependence and obstetrical outcomes adjusting for relevant confounders. Results The prevalence of opioid abuse or dependence during pregnancy increased from 0.17% (1998) to 0.39% (2011) for an increase of 127%. Deliveries associated with maternal opioid abuse or dependence compared with those without opioid abuse or dependence were associated with an increased odds of maternal death during hospitalization (adjusted odds ratio [aOR], 4.6; 95% CI, 1.8 to 12.1, crude incidence 0.03 vs. 0.006%), cardiac arrest (aOR, 3.6; 95% CI, 1.4 to 9.1; 0.04 vs. 0.01%), intrauterine growth restriction (aOR, 2.7; 95% CI, 2.4 to 2.9; 6.8 vs. 2.1%), placental abruption (aOR, 2.4; 95% CI, 2.1 to 2.6; 3.8 vs. 1.1%), length of stay more than 7 days (aOR, 2.2; 95% CI, 2.0 to 2.5; 3.0 vs. 1.2%), preterm labor (aOR, 2.1; 95% CI, 2.0 to 2.3; 17.3 vs. 7.4%), oligohydramnios (aOR, 1.7; 95% CI, 1.6 to 1.9; 4.5 vs. 2.8%), transfusion (aOR, 1.7; 95% CI, 1.5 to 1.9; 2.0 vs. 1.0%), stillbirth (aOR, 1.5; 95% CI, 1.3 to 1.8; 1.2 vs. 0.6%), premature rupture of membranes (aOR, 1.4; 95% CI, 1.3 to 1.6; 5.7 vs. 3.8%), and cesarean delivery (aOR, 1.2; 95% CI, 1.1 to 1.3; 36.3 vs. 33.1%). Conclusions Opioid abuse or dependence during pregnancy is associated with considerable obstetrical morbidity and mortality, and its prevalence is dramatically increasing in the United States. Identifying preventive strategies and therapeutic interventions in pregnant women who abuse drugs are important priorities for clinicians and scientists.

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Cassandra E. Henderson

Papers

Increase in prescription opioid use during pregnancy among medicaid-enrolled women.

Intrahepatic cholestasis of pregnancy: maternal and fetal outcomes associated with elevated bile acid levels.

Primum non nocere: how active management became modus operandi for intrahepatic cholestasis of pregnancy.

The risk of infant and fetal death by each additional week of expectant management in intrahepatic cholestasis of pregnancy by gestational age.

Perinatal outcomes associated with obstructive sleep apnea in obese pregnant women.