Drugs

4% of CDER Submissions Get Refuse-to-File Letter

An FDA study of refuse-to-file (RTF) letters found that 4% of CDER submissions from 2008 to 2017 were issued an RTF. “Overall, 84.5% (544 of 644) of the refusal reasons were for scientific deficiencies; most reasons were related to drug efficacy and safety (196 [30.4%]) and drug quality (125 [19.4%]),” the JAMA-published study said. “The remaining 15.5% of refusal reasons (100 of 644) were for application organization deficiencies or legal issues.

FDA said that a quarter of the RTF letters identified presubmission advice from the agency that applicants did not follow. The most frequently ignored advice was related to clinical trial designs, followed by product chemistry and manufacturing controls. “Given the importance of the need for sound evidence from well-conducted trials and high-quality drugs, ignoring such advice can lead to an RTF letter and delays in application review and subsequent approval of a drug,” FDA said.

Additionally, the study found that applicants “publicly disclosed the existence of 16 of 103 RTF letters (15.5%); however, only 5.4% of applicant-disclosed reasons (35 of 644) matched the refusal reasons that the FDA had provided in the RTF letters... Improved disclosure of RTF reasons may help patients, clinicians, and other applicants. For patients and clinicians, knowing that refusals occurred, as well as the reasons (if disclosed with adequate details) underlying them can provide information on the status of development of new therapies. Other applicants may learn from refusals how to avoid pitfalls in their own applications, but only if disclosures are of sufficient quality, with relevant details.”

In 2010, an FDA transparency report recommended that the agency disclose both the existence and content of RTF letters at the time of issuance, which could require amendments to FDA regulations, the study said. To date, FDA has not moved on this recommendation. While some redacted RTF letters make their way to approval packages posted on the agency’s Web site, they are often several years old by then and “provide no real-time insights into development cycles of drugs for clinicians and patients,” it found.

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