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# FDA Dismisses Concerns About Whether Approval Bar Raised
- URL: https://www.fdaweb.com/fda-dismisses-concerns-about-whether-approval-bar-raised/
- Published: 2021-03-26T12:00:00.000Z
- Updated: 2026-09-14T16:52:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148983

A wave of negative drug approval news has left industry and financial analysts wondering if FDA has raised the bar on drug approvals, but FDA dismisses the concern, claiming it is business as usual.

Over the past few months, some high-profile drug reviews have hit snags and FDA watchers are speculating a more stringent FDA is in play. For example, earlier this month, Fibrogen and partner AstraZeneca announced that FDA was requiring an unexpected review by its Cardiovascular and Renal Drugs Advisory Committee on their NDA for roxadustat for treating anemia caused by chronic kidney disease ([see story](https://www.fdaweb.com/fibrogen-hit-with-late-panel-meeting-requirement/)). Also this month, FDA told Acadia Pharmaceuticals that its ongoing review of a supplemental NDA for Nuplazid (pimavanserin), indicated for treating hallucinations and delusions associated with dementia-related psychosis, has [found deficiencies](https://www.fdaweb.com/fda-tells-acadia-that-nuplazid-snda-has-deficiencies/) that preclude labeling and post-marketing requirements/commitments discussions at this time. And on 3/19, FDA [extended by three months](https://www.fdaweb.com/abbvie-rinvoq-snda-review-extended-3-months/) its review of an AbbVie supplemental NDA for Rinvoq (upadacitinib) and its use in treating adult patients with active psoriatic arthritis.

Many FDA watchers have also lumped in recent accelerated approval withdrawals by Genentech (Tecentriq), Merck (Keytruda), AstraZeneca (Imfinzi) and Bristol Myers Squibb (Opdivo), after failing to show clinical benefit in subsequent confirmatory trials ([see story](https://www.fdaweb.com/genentech-withdraws-tecentriq-for-urothelial-carcinoma/)), as more reason to raise alarm about a potential pendulum shift with approval standards.

Taken in total, financial analysts are shaken because they like predictability. “The relatively predictable regulatory outcomes of the last four or five years may not be as predictable going forward, which of course increases the perceived riskiness of the industry,” said SVB Leerink analyst **Geoffrey Porges**.

FDA is now offering reassurance that its approval standards are unchanged and intact. “The statutory standards for new drug approval and FDA’s approach to evaluating the benefits and risks of new drugs \[have\] not changed,” a CDER Office of New Drugs spokesman told ***FDA Webview*** 3/25\. “FDA remains committed to overseeing the safety, effectiveness and quality of FDA-regulated products and helping to ensure that Americans have access to essential and innovative therapies.”  

The spokesman also acknowledged the stress of balancing resources during the pandemic while prioritizing user fee commitments. “We recently performed an [analysis ](https://www.fda.gov/industry/fda-user-fee-programs/cders-work-meet-user-fee-goals-during-pandemic?ref=fdaweb.com)of user fee metrics across our prescription drug and generic drug programs that demonstrate that FDA has been able to take on-time actions to evaluate and close out these drug applications more than 90% of the time, meeting our mandated review program performance levels,” he said.