FDA explains impact of Covid-19 on applications, formal meetings
The FDA on Tuesday issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.
The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).
Drug and biologics
FDA says its new drug and biologics programs at the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are being impacted by “considerable increases in COVID-19 related work,” necessitating shifts in resources and staff allocation.
“With many staff members working on COVID-19 activities, it is possible that we will not be able to sustain our current performance level in meeting goal dates indefinitely,” FDA writes.
FDA says it will focus its resources on applications and submissions related to Covid-19 and other life-threatening conditions and will “work directly with the sponsors and applicants regarding their pending applications.”
FDA notes that it will still aim to conduct initial investigational new drug application (IND) 30-day safety reviews and respond to “other important safety issues that may emerge during IND development.”
FDA also explains that it will communicate directly with sponsors or applicants if it anticipates missing a goal date, but notes that both the “PDUFA and BSUFA goal letters do not contemplate FDA extending or changing user fee goal dates,” except in response to submission that would trigger a clock extension.
During the public health emergency, FDA says that all meetings with industry will be held virtually, via teleconference or videoconference, noting that it has converted many previously scheduled PDUFA and BSUFA meetings from in-person to virtual at the same dates and times as originally scheduled.
FDA says it is still accepting new meeting requests “as per usual practice,” but notes that it may provide a written response only in some circumstances and may reevaluate the format of some pending meetings.
For advisory committee meetings, FDA says it is trying to figure out whether meetings can be held virtually on a case-by-case basis.
“FDA is continuing to evaluate the feasibility of conducting advisory committee meetings virtually. We believe we can host advisory committee meetings virtually with current technology,” FDA says, but adds that it will discuss the option directly with sponsors and applicants for specific applications.
For the time being, FDA says it is continuing its generic drug program application assessment activities but says that it “may need to shift resources to address urgent public health needs,” in response to shortages.
However, FDA instructs generic drug applicants to contact the appropriate project manager for their application if they “experience a missed goal date.”
FDA notes that mid-review cycle meetings and post-complete response letter meetings are typically done via teleconference and adds upcoming face-to-face pre-abbreviated new drug application (ANDA) meetings are being converted to teleconference. FDA says it will attempt to notify applicants at least four weeks in advance of a meeting format change.
FDA also says that it is prioritizing the review of ANDAs according to its recently revised manual of policies and procedures, which explains that the agency will prioritize ANDAs for drugs that are in shortage, used to address the public health emergency or otherwise meet the factors for prioritization based on competition. FDA further explains that it will consider “whether the ANDA is for a drug being investigated to treat or prevent Covid-19, but is not labeled for this use, or for a drug being used for its labeled use to treat or prevent secondary conditions associated with Covid-19.
In recent weeks FDA has announced the approval of several ANDAs for products in shortage or subject to increased demand amid the public health emergency, including hydroxychloroquine sulfate tablets, cisatracurium besylate injection, dexmedetomidine hydrochloride, succinylcholine chloride injection and azithromycin tablets.
For a look at all Endpoints News coronavirus stories, check out our special news channel.
RAPS: First published in Regulatory Focus™ by the Regulatory Affairs Professionals Society, the largest global organization of and for those involved with the regulation of healthcare products. Click here for more information.