Drugs

Bipartisan Legislation on Patent Listings

Bipartisan legislation was introduced 9/13 in the Senate and House to close a patent-listing loophole that drug manufacturers use to extend their exclusivity periods. “Because of incomplete coordination between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), drug manufacturers are currently able to unfairly extend the exclusivity period for a drug by submitting partial information for their initial patent, in order to help secure subsequent patents down the road, according to a release from legislation sponsors Senator Maggie Hassan (D-NH), Sen. Mike Braun (R-IN), and Representative Annie Kuster (D-NH) and Rep. Diana Harshbarger (R-TN). “This increases their period of exclusivity and delays the availability of lower-cost alternatives,” they said.

Their bill, the Medication Affordability and Patent Integrity Act, would require manufacturers to certify that they have not made inconsistent statements to the two agencies, helping stop abuses of the patent system, they say. The legislation builds on Hassan’s efforts last year to have FDA and USPTO start to coordinate with one another to stop patent abuses and allow for more drug competition to lower costs for patients. “Drug prices drop by as much as 20% when the first generic enters the market and as much as 85% when multiple generics enter the market,” the lawmakers note.

To read the bill text, click 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