Drugs

BLOCKING Act Would Hurt Generic Drug Access: Attorneys

Former FDA attorneys William Schultz and Margaret Dotzel (both Zuckerman Spaeder) say the BLOCKING (Bringing Low-Cost Options and Competition While Keeping Incentives for New Generics) Act, if passed, “will not accelerate generic drug entry. Instead, it will upend the critical 180-day exclusivity incentive by making it far less predictable and therefore far less valuable.”

In “An Evidence-Based Assessment of the Blocking Act,” Schultz and Dotzel say the legislation is intended to accelerate the entry of generic drugs by limiting the availability of the Waxman-Hatch 180-days of exclusivity.

The attorneys say the incentive has worked by making a significant contribution to accelerating patient access to generics for more than 35 years and has helped to increase the generic share of all prescriptions filled in the U.S. to 92% today.

The authors evaluated available data and five real-world examples to assess whether the legislation’s stated goal would be achieved. “This evaluation revealed that, in the vast majority of circumstances, BLOCKING will not accelerate generic entry, frequently because the second generic applicant will not market its drug upon approval due to patent settlements or ongoing patent litigation,” the attorneys say. “These examples also support the conclusion that, in a number of cases, delays in marketing by the first applicant are not caused by significant quality issues, one of the alleged problems that the legislation’s supporters assert are the impetus for the legislation, but rather by FDA’s own regulatory decisions and bottlenecks.”

The paper concludes that if the bill is passed, fewer generic drug manufacturers are likely to make the significant investment needed to challenge patents on expensive brand-name drugs, even when those challenges could have been successful or resulted in favorable settlements. “The net effect will be that brand-name prices will remain higher for longer, and there will be fewer generic drugs available to patients,” the attorneys say.

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’

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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