Drugs

FDA Failed to Collect $45 bil. Drug Trial Fines: Students

“Had FDA been enforcing the regulations … up to this point, the U.S. government could have imposed at least $45 billion in fines,” say three Johns Hopkins University students who are members of the Clinical Trials Transparency Committee of the Hopkins chapter of Universities Allied for Essential Medicines (UAEM). “However,” they add, “FDA has neglected to collect any.” To demonstrate their concern about clinical trial transparency, the students are planning a 5/1 demonstration at FDA headquarters to call attention to the issue.

In an article in an online university newsletter, the students say that FDA has done too little to enforce requirements that clinical trial sponsors submit applicable results to the ClinicalTrials.gov database.

“Failure to report, even when trials are unsuccessful, hurts patients and wastes the resources used in research, including taxpayer money,” the article says. “Over the past few decades, clinical trials have become more complex and time-consuming. Reporting delays can further slow the approval of novel drugs and treatments, which is especially problematic if there are no other treatment options available.”

The students note that although preliminary notice of noncompliance letters are supposed to warn noncompliant trial organizers to submit their trials within 30 days or face fines, FDA has issued only 92 such letters since 2007, although thousands of clinical trials are currently overdue.

UAEM submitted a 2/27 petition calling on FDA to:

increase enforcement of the clinical trial results reporting requirements within the FDA Amendments Act of 2007;
publish a new guidance explaining how FDA will prioritize its enforcement efforts; and
create a public dashboard of preliminary notices of noncompliance sent to noncompliant parties responsible for reporting clinical trial results.

The petition also urges that the agency issue more notices of noncompliance and civil money penalties when appropriate.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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