Drugs

Expand ‘Parallel Track’ Use: 4 Senators

Four senators — Ted Cruz (R-TX), Mike Braun (R-IN), Rand Paul (R-KY), and Mike Lee (R-UT) — are asking FDA to expand the agency’s Parallel Track provision from HIV/AIDS to other critical diseases as a way to bring life-saving drugs to patients faster. In a 5/17 letter, the four say that despite FDA efforts to streamline its drug approval process, it still takes on average 10-12 years and as much as $2.9 billion to bring a new treatment to patients.

They note that the Parallel Track was created in 1992 to allow individuals to access a breakthrough drug to treat HIV/AIDS years ahead of the drug’s final agency approval, while the drug was still in Phase 2 and 3 clinical trials.

The senators say that millions of Americans are afflicted by or dying from debilitating diseases such as Alzheimer’s disease, cancer, and amyotrophic lateral sclerosis while potentially life-saving drugs for those diseases “are mired in Phase 2 and Phase 3 of the drug approval process. Although demonstrating amazing results for the few Americans allowed to participate in clinical trials, these much-needed drugs and therapies remain years and billions of dollars of investment away from FDA approval and full access by patients.”

They suggest that under an expanded parallel track, sponsors of any drug or therapy that has successfully passed safety criteria would have the option to allow patients with critical illnesses not already enrolled in controlled clinical trials to access the drugs and therapies after consulting with their doctor.

“As we examine the budget of FDA and its potential new leadership,” the senators conclude, “we are looking for evidence that the agency seeks to act as a bridge — not a barrier — to innovation.”

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