Drugs

OTC External Analgesic Product Labeling Petition

Attorney Nancy Taylor (Greenberg Traurig) submitted a 5/24 petition asking FDA to take action to ensure that over-the-counter (OTC) external analgesic drug products in patch, plaster, or poultice (PPP) dosage forms claims are limited only to those that are demonstrated and do not include severe or acute pain. The petition says that OTC external analgesic drug products in PPP dosage forms could do much to address certain gaps in pain management. But, it says, under FDA’s regulatory approach to OTC external analgesics in PPP dosage form, only a few such products have been demonstrated to be safe and effective, and generally only for limited indications.

Taylor says FDA action as requested in the petition is needed because:

the U.S. is losing the fight against the opioid epidemic and chronic pain;
external analgesics in PPP dosage form can play an important role in addressing and managing pain, but only with incentives in place to promote the development of the data necessary to demonstrate safety and effectiveness; and
external analgesics in PPP dosage form, except for a few exceptions, have not been generally recognized as safe and effective for the management of pain, nor for chronic or moderate-to-severe pain in particular.

“The sooner FDA clarifies the specific indications for which external analgesics, particularly those in PPP dosage form, can be marketed without submission and approval of a new or abbreviated new drug application or submission of an OTC drug administrative order request and FDA issuance of such order, all of which must be supported by well-controlled clinical studies corroborated by other reliable data and evidence of safety and effectiveness, the sooner the U.S. healthcare system and U.S. consumers may have additional non-opioid alternatives in their arsenal for safety and effectively managing pain in the U.S.,” the petition concludes.

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