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  • Regulatory NewsRegulatory News

    House Passes DEA Reform Bill Changing Definition of When a Drug is 'Approved'

    The US House of Representatives has passed a new bill which promises to accelerate market access for new pharmaceutical products requiring review by the US Drug Enforcement Administration (DEA), and also changes the definition of what drug "approval" means for some new drug products. Background The bill in question, the  Improving Regulatory Transparency for New Medical Therapies Act , is meant to address a regulatory process some drug companies have described as a "b...
  • Regulatory NewsRegulatory News

    DEA Scheduling Process Targeted by Legislators Hoping to Speed up Drug Approvals

    The House of Representatives is in the advanced stages of considering legislation that could make it easier for some drug products to reach the market after being approved by the US Food and Drug Administration (FDA). Background In a notice posted to the House Energy and Commerce (E&C) Committee's website on 20 January 2015, Rep. Joe Pitts (R-PA) said he will hold a meeting on 27 January 2015 to consider several pieces of legislation, including the Improving Regulat...
  • Regulatory NewsRegulatory News

    DEA Establishes Production Limits for Painkillers, With Some Drugs Set for Big Increases

    US drug regulators have set new production quotas for dozens of controlled substances regulated under the Controlled Substances Act (CSA) , establishing the quantities of the drugs which may be produced in 2015. Quota Adjustments In a 5 September 2014 Federal Register notice , the US Drug Enforcement Administration (DEA), which is charged with setting the quotas, released a list of dozens of schedule I and II controlled substances which will be subject to produc...
  • Regulatory NewsRegulatory News

    Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle

    The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug. Background Belsomra is an orexin receptor antagonist intended to treat insomnia in patients. While its sponsor, Merck, has already obtained FDA approval to market the drug, it has been awaiting scheduling by DEA as a controlled substance under the Controlled Substances Act (CSA) . In February 2...
  • Bill Aims to Speed up Regulatory Process for Abuse-Prone Drugs

    A new piece of legislation introduced today by a bipartisan congressional duo calls for the improvement of a current regulatory stumbling block that some companies have likened to a "black hole." Background While the US Food and Drug Administration (FDA) determines whether a drug is safe and effective in the US, the determination of whether its component parts are addictive or prone to abuse falls under the authority of the US Drug Enforcement Administration (DEA) and t...
  • Attempt to Strengthen Restrictions on Hydrocodone Products Clears Second-to-Last Hurdle

    The Drug Enforcement Administration (DEA) has released a proposed rule that adopts a recommendation by the US Food and Drug Administration (FDA) to reschedule combination hydrocodone products as Schedule II substances under the Controlled Substances Act (CSA) . Background In the US, access to opioid-based painkiller medications has long been the topic of a contentious debate. On one side have been patient advocates and some doctors, who say opioids should be easily ava...
  • After Nearly a Year in Regulatory 'Black Hole,' Arena Gets DEA's Approval for Weight Loss Pill Belviq

    After a lengthy wait, the Drug Enforcement Administration (DEA) has announced the classification of lorcaserin, better known as Arena Pharmaceuticals' weight loss drug Belviq, as a Schedule IV controlled substance under the Controlled Substances Act (CSA) . The announcement comes after months of waiting by Arena. When Belviq was approved in June 2012, it was heralded as the start of a sea change in the regulatory paradigm for obesity drugs. Prior to its approval, no obe...
  • DEA's Regulatory Agenda Affects Pharma Supply Chain, Distribution and Disposal Regulations

    The US Food and Drug's Administration's (FDA) Unified Agenda may have been released late last year, but it's not the only US regulatory agency with the potential to affect the medical device and pharmaceutical industries. Several regulations proposed by the Drug Enforcement Administration (DEA), a division of the US Department of Justice, hold the potential to affect members of industry, and in particular the pharmaceutical industry. One such proposed rule, Disposal of...
  • Legislators, Regulators to Enhance Regulation of Anabolic Steroids

    • 01 August 2012
    Legislators and regulatory officials at the Drug Enforcement Administration (DEA) are both proposing to subject anabolic steroids to more stringent controls under the Controlled Substances Act (CSA) , according to documents filed in the Federal Register and at the Government Printing Office. DEA on 30 July released a final regulation classifying two additional anabolic steroids as Schedule II drugs under the CSA : prostanozol and methasterone. Under the definit...
  • FDA Looks to Reassess Hydrocodone Products

    The US Food and Drug Administration (FDA) is planning to revisit a benefit:risk assessment for a powerful painkiller subject to escalating amounts of addiction and abuse after the agency was pressed by a national drug control agency. In an 8 June Federal Register posting, FDA said it had been petitioned by the US Drug Enforcement Agency (DEA) to look at how the government classifies hydrocodone, which is subject to restrictions under the Controlled Substances Act (CSA...