Drugs

Lawmakers Press Califf on OTC Decongestant

Despite pharmaceutical researchers' skepticism for decades on the effectiveness of over-the-counter (OTC) drugs that contained the decongestant phenylephrine, why did it take FDA so long to finally consider withdrawing the products? This is the question the House Oversight Committee’s Subcommittee on Health Care and Financial Services wants FDA commissioner Robert Califf to answer in a requested staff-level briefing.

The lawmakers are reacting to FDA’s Nonprescription Drugs Advisory Committee recent vote (16 to 0) that current scientific data do not support the effectiveness of the over-the-counter monograph dosage of orally administered phenylephrine (10mg) as a nasal decongestant (see earlier story). Phenylephrine is the active ingredient found in a number of common OTC cold and allergy treatments, such as Sudafed PE and Benadryl Allergy Plus Congestion.

“We are concerned that phenylephrine has remained approved by the Food and Drug Administration (FDA) as an OTC drug ‘generally recognized as safe and effective’ (GRASE) for nearly fifty years despite strong scientific evidence supporting the contrary,” the subcommittee said in a 12/3 letter to Califf.

The subcommittee noted that for many years “scientific support for the effectiveness of phenylephrine has been consistently weak, showing that the drug administered orally provides no better symptom relief than a placebo.” The subcommittee further said it was “concerning” that FDA “relied upon outdated and insufficient evidence regarding phenylephrine’s use as a decongestant for so many years, despite numerous appeals by the scientific community. Americans seeking OTC relief should not have to worry whether they are wasting their hard-earned money on ineffective drugs.”

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