Drug Enforcement Administration (DEA)

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On August 1, 2023, the U.S. Food & Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”) issued a joint letter to all Americans to provide a status update regarding the ongoing shortage of prescription stimulants. Stimulants fall under the purview of both FDA and DEA because they are controlled substance drugs. Both agencies recognize the important role of prescription stimulants when it comes to the treatment of conditions such as attention-deficit/hyperactivity disorder (“ADHD”), binge eating disorder, and narcolepsy.

According to the letter, the agencies are working closely with manufacturers and other members of the drug supply chain to address these shortages, which are the result of two main factors—manufacturing delays and an increased demand for the stimulants.Continue Reading FDA and DEA seek to ameliorate the shortage and misuse of stimulants

The Drug Enforcement Administration (DEA) has published a new final rule regarding reporting of theft or significant loss of controlled substances. Through the final rule, the DEA amended the existing regulations governing the form and timing used to formally report these thefts or losses.

The rule, which goes into effect on July 24, 2023, adds a follow-up requirement to the initial requirement of all registrants to report the theft or loss in writing to the DEA field office within one business day of discovery. Under the new rule, the formal follow-up notice must be electronically filed with DEA within 45 calendar days of the discovery.Continue Reading DEA Adds Second Step to Reporting Procedure for Controlled Substance Theft or Loss

On June 8, 2017, the Energy and Commerce Committee voted unanimously to approve an amended version of HR 2430, the FDA Reauthorization Act (FDARA) of 2017. The bill would extend the FDA prescription drug, medical device, generic drug, and biosimilar biological product user fee programs, which are scheduled to expire at the end of September. …

On November 18, 2015, the House Energy and Commerce Committee approved several public health policy bills. Two approved bills pertain to the Medicaid program:

  • HR 3716, the Ensuring Terminated Providers Are Removed from Medicaid and CHIP Act – to implement several HHS OIG recommendations to improve CMS oversight of terminated providers and state screening of

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On November 16, 2015, the House of Representatives approved HR 639, the Improving Regulatory Transparency for New Medical Therapies Act, clearing it for the President.  The legislation would amend the Controlled Substances Act (CSA) to make procedural changes intended to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s (DEA) process for…

On November 4, 2015, the House Energy and Commerce Health Subcommittee approved the following health policy bills:

  • HR 2646, the Helping Families in Mental Health Crisis Act – includes a series of reforms intended to improve federal mental health research, screening, and treatment programs, some of which have met with strong opposition from

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Yesterday the House of Representatives approved the following health policy bills:

  • H.R. 284, the Medicare DMEPOS Competitive Bidding Improvement Act of 2015 – which would require Medicare suppliers that bid under a DME, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program to obtain a $50,000-$100,000 bid surety bond for each competitive bidding area (CBA). 

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On February 11, 2015, the House Energy and Commerce Committee approved the following bipartisan public health bills:

  • H.R. 471, Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse);
  • H.R. 639, Improving Regulatory Transparency for New Medical Therapies Act, as amended (to amend the Controlled Substances Act

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On January 27, 2015, the House Energy and Commerce Subcommittee on Health held a hearing on bipartisan public health legislation, including:

  • Ensuring Patient Access to Effective Drug Enforcement Act (to improve enforcement efforts regarding prescription drug diversion and abuse);
  • Improving Regulatory Transparency for New Medical Therapies Act (to amend the Controlled Substances Act to improve

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The Drug Enforcement Administration (DEA) has published a final rule to implement the Secure and Responsible Drug Disposal Act of 2010, which was intended to mitigate prescription drug abuse by providing safe and secure mechanisms for “ultimate users” to dispose of unused or unwanted pharmaceutical controlled substances. The regulations allow authorized manufacturers, distributors, reverse…

On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:

  • H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process

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Recent Congressional hearings on health policy issues include the following:

  • House Energy and Commerce Committee hearings on the “Helping Families in Mental Health Crisis Act”; the FDA’s proposed changes to generic drug labeling; and legislation intended to improve predictability and transparency in Drug Enforcement Agency and FDA regulation (H.R. 4299, H.R. 4069, and H.R. 4250).

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The GAO has issued a report entitled “Prescription Drug Control: DEA Has Enhanced Efforts to Combat Diversion, but Could Better Assess and Report Program Results.” The GAO notes that the DEA has expanded resources and targeted investigation strategies to collaborate with state and local entities and enhance the effectiveness of its drug diversion investigations. Among…

On June 29, 2010, the Drug Enforcement Administration (DEA) published a notice requesting public comment on whether revisions to the DEA regulations are feasible and warranted to facilitate residents of long-term care facilities to receive controlled substance medications, while adhering to the framework of the Controlled Substances Act. Comments will be accepted until August…

On March 31, 2010, the Drug Enforcement Administration (DEA) issued an interim final rule with comment period allowing practitioners to write prescriptions for controlled substances electronically and permitting pharmacies to receive, dispense, and archive these electronic prescriptions. The DEA lists a number of expected benefits to the rule. First, the policy will give pharmacies, hospitals,…