• 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...
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    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...
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    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...
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    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...
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    FDA Outlines New Communication Process for Generic Drug Companies

    The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency. Background GDUFA was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) , and is modeled off other FDA user fee programs such as the Prescription Drug User Fee Act (PDUFA) and the Med...
  • 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...
  • 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...
  • FDA: Stop Manufacturing Unapproved Oxycodone Products

    US regulators said they intend to take enforcement action against manufacturers of unapproved oxycodone products, saying the products constitute a "high public health priority" and have a high potential for misuse and abuse. Oxycodone, an opioid commonly used as a painkiller, is a schedule II narcotic under the Controlled Substances Act (CSA) , meaning it has a high probability of abuse despite its therapeutic uses. FDA said it was made aware of unapproved single-ingr...
  • 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...