• FDA to Require New Studies, Trials, Labeling Changes for Certain Opioid Products

    In a sweeping change, the US Food and Drug Administration (FDA) today announced it will require new safety labeling changes and postmarket study requirements for extended release and long-acting opioid analgesic products in a bid to curb their abuse and misuse. Background: FDA and Opioids FDA has taken a number of actions in recent years intended to cut down on the abuse of opioid products to counteract rising deaths from overdoses. In January 2013, for example, FDA sa...
  • Prometheus Slams FDA for Lack of REMS Clarity as Agency Shows Signs of Conceding

    A Citizen Petition filed by Prometheus Laboratories in May 2013 slams the US Food and Drug Administration (FDA) for failing to establish "standards and processes" for single shared Risk Evaluation and Mitigation Strategies (REMS), explaining that the current process is unprecedented, unclear and potentially raises anti-trust issues that could leave companies open to litigation. Background In 2007, Prometheus Laboratories purchased Lotronex (alosetron hydrochloride), a t...
  • FDA Announces Meeting Intended to Start Standardization Process for REMS

    US regulators have announced they will soon hold a lengthy meeting to discuss the possibility of standardizing the format and assessment process for risk evaluation and mitigation strategies (REMS), a series of tools required of some drugs by the US Food and Drug Administration (FDA) to control the potential risks associated with use of a drug product. Background REMS were first introduced under the 2007 FDA Amendments Act (FDAAA) , and were meant to act as a regula...
  • New Regulatory Science Initiative Will See Focus on REMS, Safety Frameworks and Patients

    The term " regulatory science " has been one of the hallmarks of US Food and Drug Administration (FDA) Commissioner Margaret Hamburg's tenure since she took office in 2009, and now the term is getting new institutional support in the form of a partnership with a leading healthcare organization that could make changes to the way FDA regulates many products. Background The term, which FDA defines as the "science of developing new tools, standards and approaches to assess ...
  • Government Report Shows Endemic Deficiencies in REMS Assessments

    A new report just published by the Department of Health and Human Services (DHHS) claims that the US Food and Drug Administration (FDA) lacks sufficient data to determine whether one of its flagship postmarketing safety methods, Risk Evaluation and Mitigation Strategies (REMS), is actually effective at ensuring product safety. Background REMS plans were instituted in 2007 under the FDA Amendments Act , and were seen as a response to a number of product safety scandal...
  • New Regulatory Approval Processes Proposed in New Biodefense Bill

    The US House of Representatives has overwhelmingly passed a piece of legislation that would reauthorize a wide number of public health emergency and disaster preparedness provisions, including a number that are widely utilized by the US Food and Drug Administration (FDA). Among the new provisions: a new regulatory pathway that would facilitate the approval of medical countermeasures. Background The Pandemic and All-Hazards Preparedness Reauthorization Act ( PAPRA) of...
  • US Regulators Looking into New Prescribing Paradigm for Opioids

    US regulators are preparing to hold a meeting regarding the use of opioid drugs to treat chronic pain, and whether new restrictions on their use should be required. In the 19 December edition of the Federal Register , the US Food and Drug Administration (FDA) said that its meeting is meant to address-using scientific data rather than anecdotal reports-ways to minimize the improper use and abuse of opioid drugs while maintaining access for those who rely on the drugs...
  • FDA Plans to Review REMS, ETASU Strategies for Teratogenic Products

    The US Food and Drug Administration's (FDA) Drug Safety and Risk Management Advisory Committee (DSaRM) is preparing to meet in December to discuss risk management strategies for teratogenic products. Teratogens are most commonly pharmaceutical products which, when taken by a pregnant woman, can cause birth defects or other developmental abnormalities. One of the most notorious teratogens is Thalidomide, a drug used briefly in the 1950s and 60s to treat the effects of mor...
  • Several FDA Programs to be Investigated in 2013 Under Proposed OIG Work Plan

    The US Department of Health and Human Services' (DHHS) Office of the Inspector General (OIG), an investigative body charged with overseeing program performance and integrity, plans to devote part of its time and resources to investigating several programs run by the US Food and Drug Administration (FDA) during 2013. OIG's plans were revealed on 2 October in the release of its Fiscal Year 2013 Work Plan , a 123-page document detailing the basic outline of its investigati...
  • New MS Drug Receives FDA Approval

    The US Food and Drug Administration (FDA) has given approval to a new once-a-day drug intended to treat relapsing forms of multiple sclerosis (MS), the agency announced on 12 September. Multiple sclerosis affects the connective tissue around the brain and spine, causing the immune system to attack the body's ability to communicate with itself. Though its causes remain unknown, patients are able to keep the disease in a state of remission through various treatment optio...
  • FDA Approves Vivus' Obesity Weight Loss Drug Qsymia

    The US Food and Drug Administration (FDA) on Tuesday, 17 July approved Vivus Inc's Qsymia, formerly known as Qnexa, for the treatment of obesity. The drug's approval marks FDA's second diet drug approval in as many months after a 13-year drought during which no diet drugs were approved by the agency. The agency said the drug, a combination of phentermine and topiramate extended-release, is intended for the treatment of adult with a BMI of 30 of greater, or 27 of greater ...
  • FDA Enacts New Class-wide REMS Policies for Opioids

    The US Food and Drug Administration (FDA) announced 9 July the approval of a new Risk Evaluation and Mitigation Strategy (REMS) for the most potent opioid products on the market, saying in a statement that the new policies are meant to balance patient access and safety measures to improve the safe use of the products. The new REMS policy will cover all extended-release (ER) and long-acting (LA) opioid products, and will rely primarily on educational products, which the m...