Drugs

OTC Drug Reform Legislation Introduced

Sens. Johnny Isakson (R-GA) and Bob Casey (D-PA) have introduced the Over-the-Counter Drug Safety, Innovation, and Reform Act (S. 2315) in a bipartisan effort to overhaul regulation of over-the-counter (OTC) monograph drugs. Attorney Riette van Laack (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the bill is intended to speed the current time-consuming regulatory procedures by introducing the administrative order process to replace current rulemaking procedures. It would provide options for manufacturers to request administrative orders and for FDA to initiate administrative orders on its own initiative as well as in response to a citizen petition.

Van Laack says the bill also would establish a process for introducing new OTC products that are marketed without an approved NDA. Under certain circumstances, she adds, such drugs would be subject to a two-year exclusivity period.

The bill includes provisions to give FDA authority to take rapid action in the event of safety issues with OTC drugs. And it would require that the agency evaluate the cold and cough monograph with respect to children under age of six and report annually to Congress on the progress of the evaluation.

“Importantly,” the post concludes, “the bill provides FDA with the authority to collect user fees to help cover much of the costs of the updated regulatory system and provide the necessary resources to evaluate and monitor the market.”

Van Laack says that other than the two-year exclusivity provision, the measure is like previous proposals.

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

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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