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Posted 04 October 2013 | By Alexander Gaffney, RAC,
With the shutdown of the US government this week, the US Food and Drug Administration (FDA) has been put in something of a tough spot. With questions flying around about the impact of the partial shutdown of the agency, Regulatory Focus has assembled this handy list of information you need to know about the shutdown.
The US Department of Health and Human Services (DHHS), the parent agency of FDA, said in a report that of FDA's 14,779 employees, 8,180 (55%) would remain on the job during a shutdown. That leaves 6,559, or 45%, determined by DHHS to be "non-essential" employees and thus subject to furlough.
With thousands of staff on leave this week, FDA has made several assurances that reviews already with the agency and funded by user fees-New Drug Applications, Premarket Approval applications, Premarket Notification (510k) applications, etc-are ongoing, funded by carryover user fees from the previous fiscal year. However, don't expect these reviews to happen at the same pace.
However, the speed of reviews is likely to be impacted, BioWorldwrote this week. Why? Because user fees only cover around 60-70% of the drug review process. "They're going to have to triage," Steven Grossman of the Alliance for a Stronger FDA told the publication.
FDA is definitely still approving products, as the 3 October 2013 approval of Pfizer's menopausal drug Duavee illustrates. Some reports have also indicated that FDA is still issuing additional information (AI) letters for devices as well (and presumably similar for drugs as well).
Got a new application that needs to go before FDA? Good luck with that, FDA officials have said. Right now the agency isn't accepting new NDAs, BLAs, PMAs or other applications. Why is this? Because FDA isn't legally allowed to receive or spend new user fees until Congress permits it to under new or continuing appropriations legislation.
Also on pause this week: biosimilar product reviews. BioCenturyreported earlier this week that FDA would "not work on biosimilars during the shutdown." It was unclear whether this was due to a lack of carryover fees or statutory authority or both.
Some in industry have reported that their Pre-IND meetings with FDA have been postponed, meaning their clinical trials are on a less certain path. As one insider wrote, "It's a bit terrifying… our gap funding is about to run out and our next round of funds was dependent upon the meeting with FDA."
Said a member of the Regulatory Affairs Professionals Society: "We have been unable to reach our [Pre-IND] reviewers so I am assuming no [meetings are taking place]."
For those unfamiliar with regulatory language, investigational new drug applications (INDs) and investigational device exemptions (IDEs) are the applications required for a clinical trial to go forward. At present, FDA hasn't made any statements-despite repeated requests from Focus-regarding whether it is continuing to process IDE or IND applications.
Edit: A helpful FDA insider writes in to tell us that IND submissions are still being entered into the agency's system, though it is unclear if review resources are in place to technically "accept" them or not.
We also just heard back from Steven Immergut, Assistant Commissioner for Media Affairs, who tells us: "The FDA has not placed clinical trials on hold based on the
lapse in appropriations. CDER and CBER continue to monitor existing
INDs and receive new INDs and clinical trial protocols (with the exception of
biosimilars). CDRH continues to monitor existing IDEs and receive new IDEs."
What we do know: ClinicalTrials.gov, which is run by NIH, is being maintained by "minimal staffing," meaning that registering a trial may be difficult even if FDA does approve a trial to go forward. And as Eli Lilly noted earlier this week, that website's API runs many clinical trial finder tools, which could harm enrollment.
Right now, any company with an application that's ready to be submitted is essentially holding on to it. So what happens when the shutdown ends? A crush of applications coming in to FDA all at once. In other words, expect a backlog of applications and probably some residual delays.
FDA has explained that some activities are going on as usual. Recalls, for example, have continued to be posted, though Focus hasn't seen many of the lower-risk recall classifications that normally seem to be prolific. Class 1 recall notices have continued to be posted though.
FDA told Focus that "routine establishment inspections," some "compliance and enforcement activities," the "majority" of its laboratory research testing, and the "majority" of its food safety and nutrition testing would not be carried out.
The food safety and nutrition testing point is a major one, and speaks to an important point: Without the user fee program and its carryover funds, the life sciences industry would be unable to have any products approved.
It seems to go without saying that FDA is without many of its main guidance development staff, or that the employees left have some more pressing issues to attend to. The Office of the Federal Register has said it will only publish the most pressing documents during the shutdown (unless they were already in its digital queue).
What we haven't received an answer for: Will statutorily-mandated guidances like the long-awaited social media guidance be affected if the shutdown continues for another week? And will this impact the agency's anticipated guidance documents for the current fiscal year? We'd bet as much.
Already-scheduled advisory committees are set to occur, though more general meetings are likely to be postponed. Amarin, a biopharmaceutical manufacturer, this week announced that FDA confirmed with it that a meeting scheduled for 16 October 2013 to review its drug Vascepa would take place as planned.
Own a medical device with a laser in it? You might find it difficult-if not impossible-to import it into the US. FDA is reportedly not issuing accession numbers for laser products being imported into the country, said the EU company LAPROCON, a laser safety product manufacturer, on its Twitter page.
While perhaps not of as much interest to industry, here's one that's particularly evident to Focus: FDA's press staff is at bare-bones levels this week, making the writing of this list incredibly difficult. As present the normal press office is staffed with just one official, Steven Immergut, while trade press offices reportedly also have a small handful of staff.
What this also means is that the interesting stuff that comes out of FDA, including write-ups about its new initiatives and changes in policy-aren't going to come out. That's a big blow for agency transparency in the short term, which FDA has worked hard to improve in recent years.
Another transparency measure is apparently on hold: Freedom of Information Act (FOIA) requests. These request forms are often used to access otherwise unreleased information held by FDA, most notably including FDA Form 483 inspection reports. Whatever deficiencies your competitors may have experienced, you'll have to wait to find out.
Editor's Note: We're since heard from another source that FOIA requests are definitely being processed.
For now, FDA doesn't have any money to disburse in contracts, meaning many of the projects that improve its day-to-day operations are on hold until money arrives as the agency.