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# PharmaEssentia Gets FDA Complete Response
- URL: https://www.fdaweb.com/pharmaessentia-gets-fda-complete-response/
- Published: 2021-03-15T12:00:00.000Z
- Updated: 2026-09-14T16:50:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148881

FDA has issued PharmaEssentia a complete response letter (CRL) on its BLA for ropeginterferon alfa-2b-njft for treating polycythemia vera, a rare blood cancer, requesting the need for additional data about the administration format with the product. “Importantly, no concerns were raised about the clinical profile of the product,” the company says. PharmaEssentia also says a preapproval inspection of its Taiwan manufacturing facility was delayed due to the ongoing Covid-19 public health emergency.  
  
PharmaEssentia says it is confident that it can work with the agency to address the requests highlighted in the letter and resubmit in an “expeditious manner.” Ropeginterferon alfa-2b-njft was earlier granted an orphan drug designation for the indication. The therapy has been marketed as Besremi®in Europe since 2019.

The Covid-19 pandemic has challenged FDA’s ability to meet inspection needs. Last week, the Government Accountability Office (GAO) said the agency needs to use lessons it has learned during the pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and ways to address its growing backlog of inspections. In [testimony](https://www.gao.gov/assets/720/712761.pdf?ref=fdaweb.com) before a House Appropriations Committee subcommittee that oversees FDA, GAO healthcare director **Mary Denigan-Macauley** said her organization found in 12/2019 that FDA faced many of the same challenges overseeing foreign establishments that were identified over the last two decades. “Subsequently, the outbreak of Covid-19 has added a layer of complexity,” she said.

Denigan-Macauley testified that FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused due to the pandemic. Such tools, she said, included relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs.

“Even before the Covid-19 pandemic,” she stated, “FDA faced persistent challenges conducting foreign inspections. GAO found in 12/2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA’s practice of preannouncing inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspections. In light of Covid-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that language barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services.”