Drugs

Study Questions REMS Effectiveness in Opioid Crisis

The HHS Office of Inspector General (OIG) says FDA has struggled the measure the effectiveness of the REMS (Risk Evaluation and Mitigation Strategies) for transmucosal immediate-release fentanyl (TIRF) drugs and extended-release/long-acting (ER/LA) opioids in mitigating the misuse of opioids. An OIG report says that while REMS have the potential to help address the opioid crisis, previous OIG work from 2013 raised concerns about FDA’s oversight and the overall effectiveness of REMS programs.

“This review determines the extent to which FDA has held drug manufacturers accountable for mitigating the risk of opioid misuse and abuse through REMS,” the document says.

For the REMS for TIRF drugs, the OIG says, FDA found data in the assessments suggesting that the manufacturers were not meeting all their goals and also found the data for some of the REMS goals to be inadequate. Also, it says, in assessments from 2014 through 2017, poor data left the agency unable to determine whether the REMS for ER/LA opioids was meeting its overarching goal of reducing serious adverse outcomes resulting from inappropriate prescribing, misuse, and abuse of the drugs. However, it says, FDA found that manufacturers repeatedly missed the REMS targets for training prescribers.

The OIG says that based on the review, REMS are not well suited to quickly address the opioid crisis. It says the agency concurred with recommendations that it use the new TIRF REMS patient registry to monitor for known areas of risk and that it enhance the REMS assessment review process by completing its reviews in a timely fashion and seeking information on inappropriate prescribing trends from CDER’s Office of Prescription Drug Promotion. The agency did not concur with an OIG recommendation to strengthen the REMS for opioid analgesics by requiring training for prescribers and is still considering the recommendation to seek additional authority to ensure that manufacturers are held accountable when appropriate.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome