In a decision issued on October 30, Judge Joseph Goodwin of the Southern District of West Virginia dissolved an Order of Immediate Suspension of Registration (“ISO”) issued by DEA against Oak Hill Hometown Pharmacy, a West Virginia pharmacy. Without getting too far into the factual weeds of this case, I do think there are two or three critical takeaways related to both the adjudication of this matter and to DEA’s view of Subutex vs. Suboxone.
FDA Approves New Packaging for “Poor Man’s Methadone”
While acknowledging the safety of the approved daily doses of OTC loperamide for adults (8mg per day) and prescription loperamide (16mg per day), the FDA recently approved new package-size and package-type limits for the brand-name OTC tablet and capsule forms of the drug. Here are the products affected by the FDA’s notice:
- Imodium A-D
DEA and the Surgeon General Issue Statements Regarding Marijuana
Last week was an active week when it comes to marijuana policy. The Drug Enforcement Administration (DEA) announced that it will begin considering (and approving?) applications to allow for the manufacture (growing) of marijuana for research purposes. Shortly thereafter, United States Surgeon General, Vice Admiral Jerome M. Adams (Dr. Adams), issued an advisory regarding the significant adverse effects of marijuana use by adolescents and by women during pregnancy. Both developments could foreshadow the long road ahead for marijuana legalization advocates seeking DEA’s removal of marijuana from its listing as a schedule I controlled substance.
FDA Issues Another Warning Letter Involving CBD Products
On July 23, 2019, the Food and Drug Administration (FDA) announced the issuance of a Warning Letter to the manufacturer of certain products containing cannabidiol (CBD). Specifically, the FDA provided a laundry list of examples where Curaleaf, Inc. (Curaleaf) made unsubstantiated claims on its website and on social media “that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.” The FDA considers Curaleaf’s actions as the “illegal selling of unapproved products,” pursuant to the Federal Food, Drug, and Cosmetic Act.
House Opioid Measure Frenzy Continues
Over a period of two weeks in June, the House passed several bills aimed at combating the ongoing opioid epidemic. Our summary of the earlier measures can be found here. Key points of these additional legislative initiatives are summarized below. We will continue to monitor and report on their progress.
R. 3192, CHIP Mental Health Parity Act
This bill required state Children’s Health Insurance Program (CHIP programs) to cover mental health benefits including substance use disorder services for pregnant women and children. It also prohibits states from imposing financial or utilization limits on mental health treatment that are lower than the limits placed on physical health treatment.
R. 3331
Specifically, this bill encourages the Center for Medicare and Medicaid Innovation to test models to provide incentive payments to behavioral health providers for adopting electronic health records technology, and using that technology to improve the quality and coordination of care.
House Passes 12 Bills Aimed at Combating Opioid Crisis
On Tuesday, the House of Representatives passed a fleet of bills aimed at combating the ongoing opioid crisis, most aimed at developing preventative measures to curb opioid addiction by funding research. The measures passed with overwhelming bipartisan support. Key points of these legislative initiatives are summarized below. Quarles & Brady will continue to monitor their progress.
An “Open Letter” to President Trump Regarding the Prescription Drug Abuse Epidemic
Dear President Trump,
For several years the prescription drug epidemic has ravaged communities across the United States. During that time, the Drug Enforcement Administration (“DEA”) has aggressively pursued enforcement actions against the regulated industry. Despite admirable efforts to curtail the epidemic through enforcement actions, prescription drug abuse continues to be a public health crisis. There have been many solutions put forth in the past several months. These solutions, while well-intended, failed to address the root causes of the epidemic – overprescribing of controlled substances. Mr. President, this is a unique opportunity for you to reset our approach to this crisis. As a first step, we need to reassess the enforcement-first approach of the past several years.
DEA Will Not Reschedule Marijuana
Marijuana is less dangerous than some substances in other schedules, but it will stay in Schedule I for now, DEA said Thursday. The agency also said that it supports marijuana research, is developing an online application system to apply for Schedule I research registrations, and will allow more manufacturers to grow marijuana for research.
Amendment to CSA Closer to Becoming Law
DEA Chronicles welcomes guest blogger Julia Hudson, a Q&B Health Law attorney.
On September 30, 2015, the Improving Regulatory Transparency for New Medical Therapies Act moved one step closer to becoming federal law by passing the Senate Health, Education, Labor and Pensions Committee. The bill, which was introduced on February 2, 2015 and passed
Senate Committee Questions DEA on Quota Process
On May 5, 2015, the United States Senate, Caucus on International Narcotics Control held a hearing exploring the findings and recommendations of a Government Accountability Office investigation into the Drug Enforcement Administration’s management of its quota process. The hearing, called by Senators Grassley and Feinstein, sought to explore the connection between DEA’s quota process and