Drugs

Reform Paragraph 4 Certification Process: Analysis

The West Health Policy Center says changes are needed to the generic drug Paragraph 4 certification process to stop innovator companies from using new patents to delay generic drug competition. As reported in Health Affairs, the analysis calls for:

Shifting the patent litigation burden from generic to brand manufacturers for patents filed after a brand drug is initially approved; and
Limiting damages for post-approval patent infringement by generic manufacturers to reduce the incentive to engage in patent litigation and hasten generic market entry.

“Reforming the nature of patent enforcement in the pharmaceutical sector to more closely resemble other innovative sectors while limiting infringement damages would hasten the introduction of new generic drugs, reducing drug spending and increasing patient access to therapy,” the article says.

The paper says the current Paragraph 4 requirement in the Waxman-Hatch Act encourages branded drug manufacturers to claim as many patents as possible apply to their products, requiring generic drug companies to defeat each separate patent. Also, it says, the process requires generic drug manufacturers to bear the burden of proving that claimed patents are not infringed by the proposed generic drug before the drug even comes to market.

“The pharmaceutical industry is unique,” the report says, “in both its presumption that any possible patent infringement requires a complete ban of competitors and its placement of the litigation burden on the competing product, not the originator 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

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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