Given the evolving COVID-19 situation, U.S. House committee chairs are asking the White House Office of Management and Budget (OMB) to direct federal agencies to immediately extend all public comment periods by at least 45 days beyond the end of the declared national emergency, whenever that may be.
“We are concerned that the disruptions caused by COVID-19 will deprive citizens, local communities and other stakeholders the opportunity to engage with agencies on … major policy revisions and many other rulemakings,” the committee chairs said in a letter Wednesday to OMB Acting Director Russell Vought.
Their request is not just for currently open comment periods. The legislators want the extension to apply to all comment periods that have closed since March 13, 2020, as well. The letter also asks that agencies reschedule all public hearings and meetings.
The FDA already has indefinitely postponed all its advisory committee meetings scheduled through April and one of two adcoms on the calendar for May. The other May adcom is scheduled as a teleconference to give the Cellular, Tissue and Gene Therapies Advisory Committee updates on FDA research programs.
Other meetings the FDA has on the calendar for April will be webcast, postponed or both. For instance, the MDUFA public meeting originally set for April 7 has been postponed until May 5 and will be conducted remotely. However, the fiscal 2020 Generic Drugs Regulatory Science Initiatives public workshop was still on the calendar Thursday for May 4 at the agency’s White Oak, Md., campus.
The agency does have several dockets for public comment that would be impacted should OMB follow the advice of the House committee leaders. As of Thursday, the FDA had 29 dockets that will close within the next 30 days and 19 dockets that closed between March 13 and April 2. Extending those comment periods to 45 days beyond the end of the emergency could delay finalizing guidances, research proposals, decisions on patent extensions and a whole lot more.
Many of the open and recently closed dockets involve routine agency collection requests that are submitted to OMB, but others included:
- patent extension calculations for Abbvie Inc.'s hepatitis C virus drug Mavyret (glecaprevir/pibrentasvir) and Intrarosa (prasterone), a daily non-estrogen product for the treatment of moderate to severe dyspareunia that Amag Pharmaceuticals Inc. licensed from Endoceutics Inc.;
- ways to establish a competitive biosimilar market;
- draft guidance on the labeling for laparoscopic power morcellators;
- reclassification of certain HIV tests;
- advancing animal models for antibacterial drug development;
- electronic submissions and data standards under PDUFA;
- modernization of the FDA’s data strategy;
- draft guidance for arthroscopy pump tubing sets intended for multiple-patient use;
- revised product specific guidance for levonorgestrel;
- the future of rare disease product development;
- a draft Q&A guidance on pediatric study plans for oncology drugs;
- draft guidance on 510(k) submissions of peripheral percutaneous transluminal angioplasty and specialty catheters;
- draft guidance on demonstrating substantial evidence of effectiveness for drugs and biologics.