Drugs

FDA Obstacles Lead to Overseas Trials: Survey

While U.S. biotech companies focused on treating rare and serious diseases overwhelmingly prefer to conduct first-in-human (FIH) clinical trials in the U.S., historical obstacles posed by FDA are prompting the companies to seek development overseas. That’s a key finding from a survey of 37 U.S. biotechnology executives conducted by the Biotech Consortium to Accelerate Innovation. A survey report says:

76% of interviewees pick the U.S. for FIH trials when review is predictable;
72% are hesitant to run FIH trials in the U.S. under FDA’s historical framework;
73% say the top reason why sponsors are leaving the U.S. is delay and financial cost tied to FDA clinical holds and rework;
surveyed executives cite “current turmoil at FDA with high turnover” and warn the U.S. is “offshoring our industry faster than we can catch up”;
54% of the executives say they are less likely to test new drugs in the U.S.; and
85% support fixing FDA’s “1/10 rule” so it sets a safe starting dose and not a treatment ceiling.

Proposed solutions identified in the survey are:

clarify that the 10x safety margin sets a starting dose and not a treatment ceiling as outlined in a 2005 FDA guidance;
restore predictable review timelines that reduce costly holds and rework;
strengthen sponsor-reviewer communication so trial design is driven by science, not procedural ambiguity;
ensure better alignment of review criteria with disease severity and life expectancy;
improve benefit/risk framework that considers the patient’s voice; and
use a central institutional review board for first-in-patient studies.

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