Drugs

Converted OTC Products are Not ‘Listed Drugs’: FDA

Attorney Michael Shumsky (Hyman, Phelps & McNamara) says FDA has changed a longstanding practice and now says a full switch to over-the-counter status through an sNDA does not create a new listed drug and thus does not create a new period of 180-day exclusivity. Writing in his firm’s FDA Law Blog, Shumsky says the change was contained in a previously undisclosed agency memo that the firm obtained through a Freedom of Information Act request.

Shumsky describes the change as the latest FDA attempt to rein in or even eliminate 180-day exclusivity for the first generic applicant to challenge an NDA holder’s patent monopoly.

His post says FDA provides little interpretive justification for its new approach and appears to base it entirely on a superficial change in administrative practice in how products are numbered in the Orange Book.

“The consequences of FDA’s previously undisclosed change are clear: it allows NDA holders to effectively gut the 180-day exclusivity incentive by effectuating an OTC switch after receiving a first applicant’s Paragraph 4 certification,” Shumsky concludes. “For applicants who certify to a listed patent when the product is prescription-only, OTC conversion renders 180-day exclusivity illusory because the product can no longer be marketed lawfully following the OTC switch.”

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