Drugs

Big Changes to Waxman-Hatch Regs Outlined

FDA published 10/6 a Federal Register notice with final regulations to implement some of the provisions of the 2003 Medicare Modernization Act. Attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog that the final rule “will forever alter the Waxman-Hatch landscape and will likely fuel controversies and provide fodder for litigation for years to come.”

While attorneys continue to review the final rule to prepare summaries and analyses, Karst provides highlights of the 79-page rule provided by FDA. He says that perhaps the most significant change is the agency’s decision to drop, at least for now, a proposal to defer to a 505(b)(2) or ANDA applicant’s interpretation of the scope of a patent that it does not own (and, in particular, for a method-of-use patent that is identified in the Orange Book with a patent use code and narrative).

Instead, Karst says, FDA will institute a patent listing dispute mechanism whereby the “NDA holder must provide a narrative description (no more than 250 words) of the NDA holder’s interpretation of the scope of the patent that explains why the existing or amended ‘use code’ describes only the specific approved method of use claimed by the patent for which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product.”

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