The 2018年12月22日 partial shutdown of the United States government affected roughly 25% of federal agencies, including the Food and Drug Administration (FDA), which has furloughed about 40% of its overall workforce. The duration of the shutdown is uncertain. In light of this uncertainty, it is important to understand the impact of the government shutdown on the FDA.
FDA is using social media as a primary channel for communicating with the public for the duration of the shutdown, which is where we obtained the following information. We recommend you follow FDA, FDA Tobacco, and Commissioner Scott Gottlieb, MD on Twitter for updates. We will also continue to compile and communicate updates so be sure to follow Synchrogenix as well.
FDA’s shutdown plan provides for the continued work of more than half of its employees who will continue conducting activities within user fee funded programs. FDA carryover user-fee funds allow the agency to continue work on existing user-fee related applications. Additionally, FDA will continue to conduct emergency work to protect consumers, such as continuing to oversee food recalls and monitor and respond to outbreaks of foodborne illnesses.
User Fee Funded Activities During FDA Shutdown
- Review and approve some types of drug and other medical product applications to ensure patients have access to new and innovative medicines.
- Review requests to conduct important clinical research, issue guidance, and other necessary activities to help patients have access to new therapies.
- Oversee manufacturing, distribution, and marketing of tobacco products and efforts to educate about their dangers.
FDA Shutdown Impact on New Applications
During the shutdown, FDA CANNOT:
- collect FY 2019 user fee payments;
- accept new applications for products under user fee programs: PDUFA, GDUFA, BsUFA, MDUFA, ADUFA, AGDUFA;
- For PDUFA products, FDA will accept new regulatory submissions for which no fee is required, such as INDs, annual reports, supplements to NDAs and BLAs, submissions that fall within fee exemptions, and general correspondence. This includes submissions that fall within the fee exemption for previously filed applications and applications for which FDA has waived the application fee.
- accept any regulatory submissions for FY 2019 for new drugs, medical devices, or biologics that require a fee payment and that are submitted during the lapse period, unless the required user fee was paid before 2018年12月22日.
FDA Shutdown Impact on GDUFA
- FDA will not accept generic drug submissions that require payment.
- New GDUFA submissions that will be processed with carryover user fees include CBE and prior approval supplements, amendments, annual reports, applications for PET drugs, and general correspondence.
- FDA will accept Drug Master Files, including Type II Active Pharmaceutical Ingredient (API) DMFs, to be referenced in generic drug applications. However, FDA cannot conduct initial completeness assessments on Type II API DMFs if the fee hasn’t been already paid.
- If a generic drug application references, for the first time after Dec 22, 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days.
- Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees. Fees that are due during the lapse period may be paid as soon as the lapse period ends.
FDA Shutdown Impact on Biologics
- CBER will pause non-emergency work on whole blood, blood components for transfusion, allergenic extracts and HCT/Ps regulated solely under Sec. 361 of the PHSA since it cannot be conducted with carryover user fee funding.
- The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.
- New emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.
FDA Shutdown Impact on CDER
- Pausing all OTC monograph drug activities.
- The 30-day review clock for any pending, non-emergency IND for a medical product that is not covered by a user fee program will be suspended during the lapse period. The clock will resume when the lapse period is over.
- New emergency INDs and IND amendments that relate to the safety of individuals who are participating in clinical trials will continue to be reviewed during the government shutdown, even for products that are not covered by a user fee program.
FDA Shutdown Impact on Tobacco and ENDS
- With carryover user fees, FDA Tobacco will continue carrying out the Tobacco Control Act, overseeing the manufacturing, distribution, and marketing of tobacco products, and efforts to combat the epidemic of youth e-cigarette use and access to all tobacco products.
FDA Shutdown Impact on Importation
- Entry review of all products to determine the potential risk to health (for example, to determine whether the product poses an imminent threat to health/life).
- Examination, including sampling, of products that may pose a high risk to health will be conducted.
- Detention of product, including products subject to detention without physical examination, if product may pose a high risk to health will occur.
- Mail Facility operations: examination of packages to detect counterfeit and other products that may pose high risk to health shall also happen.
We will continue to monitor the FDA’s response to the government shutdown and share any new information we feel would benefit our clients via our social media channels. In the meantime, please leave your questions in the comments or contact us to learn more.
