Drugs

Law Blog Faults FDA on Remote ‘Evaluations’

Attorney Douglas Farquhar and senior regulatory expert Richard Lewis (Hyman, Phelps & McNamara) say the fact that FDA has conducted fewer than 10 remote interactive evaluations (RIEs) at drug manufacturing sites since 4/2021 is a “missed opportunity,” given that on-site inspections dropped off dramatically three years ago due to Covid-19. Writing in their firm’s FDA Law Blog, the two say the number of facility RIEs is a stark contrast with the number of RIEs, more than 100, conducted as part of the Bioresearch Monitoring Program.

The two also analyze FDA’s 10/2023 draft guidance about RIEs which they say contains very little that is new or different from the Covid-centered version that was released in 4/2021.

“Under the new guidance, many of the same conditions apply as under the one that was issued 30 months ago,” they write. Key provisions are:

requests for documents and virtual inspections are both considered “remote regulatory assessments”;
FDA does not intend to accept requests from applicants or facilities to perform an RIE;
RIEs may specifically be used to conduct preapproval inspections;
FDA will require facilities to accommodate the use of teleconference, livestream video, and screen-sharing of data and documents;
the guidance applies to facilities manufacturing human drugs, biologics, and veterinary medications, and to clinical sites for drugs; and
responses to written observations made as a result of an RIE will not be made on a form FDA-483, but facilities are still “encouraged” to file responses within 15 business days.

Farquhar and Lewis say these things were added in the new draft:

facilities where FDA requests that an RIE be performed need to consent in writing, while it is not clear what would happen if the facility refused; and
comments on the guidance are invited, unlike the 4/2021 guidance that was implemented immediately without public participation.

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