Drugs

Senators Urge FDA to Strengthen Opioid Studies

Senators Edward Markey (D-MA) and Joe Manchin (D-WV) are calling on FDA to curb the use of enriched enrollment randomized withdrawal (EERW) studies, which they say have been used to investigate opioid treatment options for patients with chronic pain but carry the risk of biasing outcomes in favor of opioid approvals.

“From members of Congress to medical experts and researchers, concerns have been raised about the safety and validity of EERW studies,” the lawmakers say in a release. “According to an FDA-commissioned report, EERW studies underestimate opioids’ adverse impacts. In April, members of the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) criticized EERW studies for their potential risk of harming participating patients by introducing opioid use to patients who were previously not using opioids, prescribing and maintaining opioid doses at their highest tolerance level, and then abruptly stopping opioid use, which can induce withdrawal.”

In a 9/21 letter to FDA commissioner Robert Califf, the senators said: “Based on the risk associated with EERW studies and the availability of other study models, we ask the FDA not to permit the use of EERW to determine the long-term efficacy and tolerability of opioids in chronic pain patients. We also urge you to reject EERW study designs for any future new drug applications for opioids and reconsider past opioid approval decisions using EERW. For too long, drug manufacturers have been given the benefit of the doubt in developing and marketing a drug that unleashed a widespread, decades-long epidemic. Using a study model that risks continued bias in favor of approval is unacceptable.”

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