Drugs

FDA Authorizes 1st ‘Parallel REMS’

FDA has approved its first “Parallel Systems REMS” as part of the approval of four generic versions of Gilead’s Letairis (ambrisentan) for treating pulmonary arterial hypertension. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that FDA explained that three generic manufacturers of ambrisentan were joining Gilead in a single, shared REMS system using the same distribution method to dispense only to female patients through specialty pharmacies as has been in place for the branded drug. The other generic manufacturer is not entering that shared system because doing so would prevent use of retail pharmacies for product distribution, FDA said.

Koblitz writes that FDA emphasized that the separate REMS program “achieves the same level of safety as the REMS for the brand-name ambrisentan.”

Approval of the parallel system came under the agency’s REMS waiver process, according to Koblitz, in which FDA can waive a requirement for a shared, single system if it determines that the burden of creating such a system outweighs the benefit of the single, shared system or the reference-listed drug’s system is covered by a patent or other trade secret protection.

She says the ambrisentan waiver is the first since the 6/2018 publication of an FDA waiver guidance, and it’s too early to tell what impact the guidance has had on waiver requests, particularly because no waiver decision has been issued yet and it’s not clear that a formal decision will be issued.

“But,” she says, “it’s exemplary of FDA’s ongoing commitment to working with ANDA holders on expediting generic entry, particularly when hurdles arise in the negotiation of a shared REMS, which may suggest anticompetitive motives.”

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