Tag Archives: FDA

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 … Continue Reading

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. … Continue Reading

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 in the House on … Continue Reading

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 … Continue Reading

GAO Report Criticizes DEA Quota Process

On March 4, 2015, the Government Accountability Office (GAO) released a report titled, Drug Shortages: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved.  GAO’s report examined, (1) the trends in such shortages, (2) the effect on patients and providers, (3) DEA’s administration of the quota … Continue Reading

Second Bill Introduced in the Senate to Amend the Controlled Substances Act

As we previously reported, on February 12, 2015, Senators Hatch and Whitehouse introduced the Ensuring Patient Access and Effective Drug Enforcement Act of 2015.  Also on that date, the Senators introduced legislation that would also amend the Controlled Substances Act, as well as the Food, Drug, and Cosmetic Act.  This legislation addresses, among other things, … Continue Reading

DEA Takes the First Step Towards Rescheduling Hydrocodone Combination Products

On Thursday, February 27, 2014, the DEA issued a long-awaited Notice of Proposed Rulemaking (NPRM) seeking to reschedule hydrocodone combination products as Schedule II controlled substances.  In a previous post we questioned whether such a step would actually have an impact on the abuse and diversion of these drugs.  DEA relied on the scientific analysis … Continue Reading

Changes Ahead: New Rules for Painkillers

FDA Announces New Labeling and Postmarket Studies Requirements for Painkillers On September 10, 2013, the FDA announced its plan to issue new regulations for labeling extended-release and long-acting (ER/LA) opioid analgesics intended to treat pain.  According to the FDA, the labeling changes “will include important new language to help health care professionals tailor their prescribing decisions … Continue Reading

Eisai Inc. Sues DEA

On Monday, Japanese drug maker Eisai Inc. filed a lawsuit against the DEA in the District of Columbia Court of Appeals.  Their complaint?  Eisai created a drug, called Fycompa, that the FDA approved last October to treat epileptic seizures.  Due to FDA’s scheduling recommendation and the drug’s effect on the central nervous system, the DEA … Continue Reading
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