Acknowledging the challenges it’s facing in conducting onsite inspections, the FDA issued guidance this week on the review timelines it’s using during the pandemic for applicant responses to agency complete response letters (CRLs) when a facility assessment is necessary.
In effect for the duration of the public health emergency, the guidance applies to inspections of manufacturing facilities and bioresearch monitoring (BIMO) program sites conducting clinical, analytical and nonclinical studies.
The guidance discusses the FDA’s temporary policy on review timelines on CRL responses that require an inspection that can’t be conducted in a timely manner because of COVID-19 or that involve the use of time- and resource-intensive alternative tools to assess a facility or BIMO site.
Under the guidance, amendments to original abbreviated new drug applications (ANDAs) and amendments to prior approval supplements to approved ANDAs will be received as a major amendment, regardless of whether the CRL contains a major deficiency.
Resubmissions of original applications and efficacy supplements for new drug applications (NDAs) and biologic license applications (BLAs) will be subject to a class 2 review timeline of six months.
Existing BsUFA timelines will remain in place for resubmissions of original biosimilar applications, supplements with clinical data, and manufacturing supplements – regardless of whether the FDA conducts an inspection or uses alternative tools for the facility assessment.
Resubmissions of manufacturing supplements for NDAs and BLAs also will continue to be subject to existing user fee timelines, the FDA said.
USPTO to expand diversity in innovation
The U.S. Patent and Trademark Office (USPTO) is seeking public comment to help develop a national strategy to build a more demographically, geographically and economically inclusive innovation ecosystem in the U.S.
“To maintain the United States’ economic competitiveness on the world stage, it is imperative for our nation to encourage individuals from all backgrounds and areas of the country to participate in the innovation ecosystem, particularly in obtaining intellectual property rights,” the USPTO said in a notice to be published in the Dec. 23 Federal Register.
To help expand the innovation ecosystem to underrepresented groups, the USPTO is seeking information on areas such as current barriers, the role government should play in toppling those barriers, best practices for organizations to measure their own progress on intellectual property protection, and short- and long-term metrics for measuring the nation’s progress in realizing greater entrepreneurial inclusion and diversity.
Comments referencing Docket No. PTO-P-2020-0057 should be submitted to regulations.gov by Feb. 6.
Opioid prescriptions could cost Walmart billions
Seeking what could be billions of dollars in civil penalties, the U.S. Department of Justice (DoJ) filed suit Dec. 22 against Walmart Inc., alleging that the company unlawfully dispensed controlled substances from its pharmacies across the country during the height of the prescription opioid crisis.
The suit, which stems from a multiyear investigation by DoJ’s Prescription Interdiction and Litigation Task Force, claims Walmart pharmacies filled thousands of prescriptions for controlled substances that were not issued for legitimate medical purposes and outside the ordinary course of pharmacy practice.
The civil suit also alleges that the company’s distribution centers received hundreds of thousands of suspicious orders that they failed to report as required to the Drug Enforcement Administration. These actions “helped to fuel the prescription opioid crisis,” DoJ said, noting that the Walmart distribution centers stopped distributing controlled substances in 2018.
Walmart could face civil penalties of up to $67,627 for each unlawful prescription filled and $15,691 for each suspicious order it didn’t report, according to DoJ.