The US Food and Drug Administration (FDA) may be experiencing a partial shutdown due to the lapse in government-appropriated funding, as well as the authority to collect and spend new user fees from industry, but that hasn't entirely stopped its development of new regulations and guidance documents.
Required Guidance: Remember FDASIA?
Under the 2010 Food and Drug Administration Safety and Innovation Act (FDASIA), the agency is required to develop and implement various regulations and guidance documents by specific dates. A popular example is the much-anticipated "social media guidance," which is due out by the agency by the summer of 2014.
But with the government shutdown, Focus wondered if such guidance development would be affected and, if so, what that might mean for meeting FDASIA's requirements.
In looking through the agency's FDASIA-Track webpage, which curates the law's requirements for the agency and the dates by which those requirements are due, it is clear that the shutdown comes at something of a fortuitous time for the agency. FDA has little in the way of statutory requirements in the coming weeks and months, which other documents that were planned for publication around this time had voluntary schedules for release.
For example, a draft guidance on custom devices had been planned for release by 30 August 2013 (but wasn't released), but is not technically due until August 2014. In another case, FDA said it would issue a proposed rule on current good manufacturing practices, also in August 2013. No specific requirements dictated its release, however. Another eight documents were due for release in September 2013, but have not been tallied by FDA as having been released.
The good news, according to FDA, is that the development of new guidance and regulations is ongoing, though at a potentially reduced rate.
When reached for comment, FDA spokeswoman Lisa Kubaska confirmed that "the Center for Drug Evaluation and Research's (CDER) Office of Regulatory Policy (ORP) is continuing to work on regulations and guidances that are within the scope of the [Prescription Drug User Fee (PDUFA)] program."
The PDUFA program was reauthorized under the 2012 FDASIA legislation, as were a host of other user fees bills like the Medical Device User Fee Act, the Generic Drug User Fee Act and the Biosimilar User Fee Act.
However, Kubaska said, "FDA activities are subject to resource constraints due to the lapse in appropriations and may be delayed in the event of a protracted lapse period."
FDA has already confirmed that such reviews are ongoing as a result of so-called "carryover" user fees from the prior year, and that each department has varying amounts of fees. CDER remains well-funded, with more than $100 million in funding in the bank, while the Center for Devices and Radiological Health (CDRH) has less than $20 million. The agency's biosimilar program has no carryover funding to use, and the agency said it would have to stop development on its biosimilar guidances.
While most deadlines appear unlikely to be affected much in the short term, the shutdown could push back some releases by weeks, and it now seems unlikely that many non-FDASIA guidance documents will see the light of day by the end of the 2013 calendar year.