The US Food and Drug Administration (FDA) on Wednesday finalized guidance outlining its expectations for the format and content of a risk evaluation and mitigation strategy (REMS) document for certain high-risk prescription drugs and biologics that pose safety concerns and incorporates “extensive” stakeholder feedback, said the agency.   The draft version of the guidance was first issued for comment in 2017. (RELATED: REMS Format and Content: FDA Offers Draft Guidanc...

The US Food and Drug Administration (FDA) proposed to modify its Opioid Analgesics Risk Evaluation and Mitigation Strategy (REMS) program on Wednesday to require that a mail-back envelope be supplied along with prescriptions filled in the outpatient setting, so that unused opioids can be returned for disposal. Mail-back envelopes would be postage-paid.   The proposal aims to reduce the risk that unused pills will cause accidental overexposure or addiction.   “The...

The US Food and Drug Administration (FDA) is modifying the shared Risk Evaluation and Mitigation Strategy (REMS) for mifepristone products to allow women to continue to access the abortion medication through the mail via a certified prescriber.   The move, highlighted on FDA’s mifepristone information webpage and in updates to an associated question-and-answer (Q&A) page on 16 December, makes permanent the eased restrictions permitted during the COVID-19 pandemic. At...

Five generic opioid drugs are being withdrawn from the market by the US Food and Drug Administration (FDA), according to a Federal Register announcement.   The action comes after the holders of the abbreviated new drug applications (ANDAs) “have repeatedly failed to file required annual reports for those ANDAs and have failed to satisfy the requirement to have an approved risk evaluation and mitigation strategy (REMS),” wrote FDA in announcing the withdrawal.   T...

The US Food and Drug Administration (FDA) this week revised its manual of policies and procedures (MAPP) to reflect recent statutory changes that make it easier for drugmakers to develop separate risk evaluation and mitigation strategies (REMS) with comparable elements to assure safe use (ETASU).   The Further Consolidated Appropriations Act, 2020 , which was enacted late last year, included two provisions aimed at increasing generic and biosimilar competition.   ...

The US Food and Drug Administration (FDA) has released a memorandum explaining why it waived the requirement of a single, shared system (SSS) risk evaluation and mitigation strategy (REMS) for generic versions of Gilead’s Letairis (ambrisentan), which treats pulmonary arterial hypertension. This is just the fourth time in FDA’s history that it has waived an SSS REMS for generic competitors. Because the process of creating an SSS can be time-consuming and complex, such a...

Industry groups representing the pharmaceutical, biotechnology and generic drug industries are calling for changes to two recent US Food and Drug Administration (FDA) draft guidances on risk evaluation and mitigation strategies (REMS).   The draft guidances , released for comment in January, detail a framework for companies to develop an assessment plan for their REMS programs and provide recommendations for surveying patient and health care provider knowledge of REMS...

The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2016 detailing the factors that the agency uses to determine whether a risk evaluation and mitigation strategy (REMS) is necessary for a drug. As defined by the guidance, a REMS is a required risk management plan that can include one or more elements to ensure that the benefits of a drug outweigh its risks. Such elements can include a medication guide, a package insert or a communication plan ...

The Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) medicines is being strengthened by the US Food and Drug Administration (FDA) to better ensure the appropriate patients are receiving these opioids, the agency announced Wednesday. Following an advisory committee meeting on the REMS last August, as well a recently published study in JAMA that found that “thousands of patients receiving TIRFs were opioid-nontolerant...

Research published in JAMA on Tuesday details how a US Food and Drug Administration (FDA) class-wide Risk Evaluation and Mitigation Strategy (REMS) did not prevent the inappropriate prescribing of transmucosal immediate-release fentanyls (TIRFs), which were approved solely for breakthrough cancer pain in opioid-tolerant patients. The study, conducted by researchers from the Johns Hopkins Bloomberg School of Public Health and the Center for Science in the Public Intere...

Back in November 2017, FDA Commissioner Scott Gottlieb called on brand name drug companies to “end the shenanigans” around delaying or restricting generic drug competition. But that call to action has not stopped brand name companies from continuing to pursue at least one gaming tactic, which is refusing to provide samples to competitors looking to bring generic products to market. As part of an effort to deter such a tactic, FDA recently created and updated a list o...

The US Food and Drug Administration (FDA) on Thursday released two new draft guidance documents aiming to help improve the agency’s ability to ensure that Risk Evaluation and Mitigation Strategies (REMS) put in place for certain drugs and biologics are working properly. The guidances provide industry with a framework to develop a REMS Assessment Plan to better develop a REMS program and improve the quality of the information used to assess the effectiveness of it, and t...