Drugs

Bill Would Prevent ANDA Blocking on 1st Generics

Senators Tina Smith (D-MN) and Mike Braun (R-IN) have reintroduced bipartisan legislation that would prevent pharmaceutical company actions to block generic drug competition through a practice called “parking.” The senators say that parking occurs when a brand company agrees not to sue the first company that submits an application to market a related generic (first filer) and enters into an agreement where this first filer agrees to delay bringing its generic drug to market. “No other company can bring a generic version of a brand name drug to market until 180 days after the first filer has done so,” they say, adding that such anti-competitive agreements allow fewer lower-cost generic products to come to market.

The lawmakers’ Expanding Access to Low-Cost Generics Act would attempt to solve the parking problem by:

Allowing generic companies that are not first filers the ability to receive 180-day market exclusivity if the first filer does not come to market after a specified time-frame.
Changing the incentive structure for generic companies so that first filers rush to come to market rather than “park” their products.
Stopping the bottleneck of generic products waiting to come to market.

A summary of the bill can be read here.

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