Drugs

Longer Drug Review Time Means Fewer Approvals: CBO

The Congressional Budget Office (CBO) says a nine-month increase in FDA review times for NDAs would reduce the number of FDA-approved drugs in the first year following the increase. The CBO analysis was in response to a request from Democratic leaders of four House and Senate committees with FDA oversight.

“In addition to the initial delay,” CBO says, “the increase in review times would reduce the number of such approvals by raising the cost to develop new drugs.”

CBO says it estimates that a nine-month increase in FDA review times would result in three fewer drugs entering the market in the first decade after the increase and 10 fewer drugs in both the second and third decades. “CBO also expects that FDA would issue fewer supplemental approvals for drugs already on the market because of the increase in costs, since approving new uses follows a regulatory process that is similar to that for new drugs,” the response says.

The agency notes that an increase in review times would probably affect drug development in ways that it did not assess. “Increases in FDA review times effectively reduce the period during which a drug manufacturer has exclusive rights to sell a drug, thereby lowering expected revenues,” it says. CBO did not assess the effects of that decrease in expected revenue of new drug development. The agency also did not assess the effects of other changes in the behavior of drug companies in response to longer review times, such as changes in the types of drugs selected for development. Finally, CBO’s analysis did not account for any changes in FDA processes or practices that might result from increased review times.

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