Drugs

Do More to Promote Generic Competition: White Paper

A Brookings Institution white paper says there are steps FDA could take to better promote generic competition. The paper focuses on three areas of FDA authority that Brookings says “could be refined to better promote generic competition: the Citizen Petition mechanism, the approval of so-called complex generic drugs, and the phenomenon known as ‘parking’ under the Waxman-Hatch Act.” Policy recommendations are:

strengthen FDA authority to dismiss citizen petitions and penalize non-meritorious filers by instituting time limits and associated penalties;
improve the transparency of FDA’s review of citizen petitions by requiring the agency to report more details about delays and the review process;
for drug/device combinations, relax the sameness standard from substantial equivalence to functional equivalence, even if that necessitates some modest training by healthcare providers;
streamline the review of ingredient sameness for injectable complex generics;
establish a defined period for review of citizen petitions requesting therapeutic equivalence under the 505(b)(2) pathway;
amend 180-day exclusivity provisions to specify a presumption that any patent litigation between generic and innovator firms that does not allow for immediate generic entry be viewed as grounds for forfeiture of the 180-day exclusivity period; and
create additional financial incentives to encourage at-risk launching by the first generic filer.

The paper says the policy recommendations “are by and large modest and are grounded in the assessment of existing practices and the barriers to competition they create. The types of policy changes proposed here would be expected to yield significant cost savings from enhanced competition

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