Drugs

Panelists Worry About Cures Act Drug Approvals

Panelists at a Harvard School of Public Health forum on “The 21^st Century Cures Act: Implications for Research and Drug Development,” expressed concerns about the faster FDA drug approvals envisioned under the law. American Cancer Society chief medical officer Otis Brawley said that mere ineffectiveness is not the worst thing that can happen with a new drug. In the past, he said, people have been harmed by flawed compounds and medical devices meant to help. “I hope we don’t do that in the future, but I fear we will,” he said.

Harvard Medical School professor Aaron Kesselheim said that faster FDA drug approval decisions will result in decisions based on less-rigorous science. Brawley said that means that more drugs will be approved whose negative or harmful effects won’t be detected until they are in broader use. He said that’s why the agency should increase post-approval monitoring so that drugs that prove harmful once on the market can be quickly detected and recalled. “Many parts of the bill overemphasize speed over science,” Kesselheim noted.

Clinical Trials Transformation Initiative Pamela Tenaerts questioned whether a faster approval has to mean a less rigorous approval. She said the change allows FDA to examine additional evidence, such as patient experience, which would provide a potentially valuable perspective about how a drug performs in the real world. She did, however, agree that smaller trials are not as revealing as larger clinical trials, and that it’s important that patients enrolled in trials be aware of the risks involved. “Smaller numbers come with greater unknowns,” she said.

Panelists praised the increased research funding for the National Institutes of Health included in the law but raised concerns that the agency still may not see the funds because actual allocation must be approved by the administration and Congress.

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