Drugs

Hard to Assess Opioid Deterrence: FDA

A team of FDA researchers says that it can be difficult to interpret post-marketing surveillance studies on the effectiveness of opioid abuse deterrent properties because the underlying sampling mechanisms can bias the results in unpredictable ways. Writing online in Pharmacoepidemial Drug Safety, the researchers say that using comparators has the potential to disentangle the effect due to the abuse-deterrence properties from those due to other interventions. However, they say, identifying a meaningful comparator can be very difficult.

The article addresses two important issues stemming from use of surveillance data — the ability to make statements about association in the community using data from a sample (estimability), and the ability to make statements about the cause of an observed association (causality).

According to the researchers, pre-market evaluations may suggest an expectation of reduced abuse, but they don’t ensure that there will be reduced abuse in the population, either overall or via specific routes. Thus, the purpose of post-marketing studies is to assess whether an abuse-deterrent formulation has caused a meaningful reduction in abuse of the product in the population.

“Ideally, if we have a well-defined population and if we could count all abuse events in that population, we could make statements about association between abuse deterrent formulations and abuse deterrence over time,” the article says. “Obtaining population-level data with information about which particular opioids were abused is challenging. An alternative is to select a probability sample from a well-defined population that can then be used as a basis for making statements about association in that population using weights and other design information that reflect the sampling scheme.”

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

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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