Usually when a clean bill such as the User Fee legislation gets amended, it could spell trouble for the bill. However, in the case of recent bipartisan amendments to the User Fee legislation to reauthorize the User Fee Acts(UFAs), there is a clear and beneficial impact from the industry’s perspective.
The Amendment, which was paired down to remove some of the objectionable and potentially congressionally unpalatable and Agency unworkable issues (like expedited review in 150-days for certain ANDAs subject to drug shortage and where there was limited competition), now appears to have support in Congress and with the industry.
Changes to expedited review for certain application to 8 months (240 days) are much more in line with the GDUFA II negotiated goals. It also expands the number of approved ANDAs to 3 or fewer for an ANDA to be expedited, requires firms to provide a list of marketed products to FDA (so FDA can publish a list) and report discontinuations or withdrawals of ANDAs or sale of the application 180-days prior to the event happening. This 6-month timeline may be a bit more difficult to live with because sometimes things are out of a firm’s control.
One of the major issues addressed in the amendment is the revived attention to the ANDA suitability petition process. (see description of the problem and the process here and here). Many suitability petitions pending at the Agency have been languishing for years and some upwards of 8+ years. The amendment requires the Agency to report publicly on petitions that are older than 180-days without decisions. Remember that FDCA has a statutory requirement that ANDA suitability petitions be responded to with 90 days. This amendment acknowledges the sense of the Senate that FDA fulfill its statutory responsibility relative to review of such petitions.
A summary of the amendment can be found here. While this amendment may make for more work for the FDA, it is certainly welcomed by industry and I don’t believe can be conceived as overly burdensome and certainly in line with current nationally important economic challenges and FDA statutory responsibilities.