For many years, innovators have used the petition process to gum up ANDA and 505(b)(2) approval process and hopefully delay FDA clearance of such applications. Because of this problem, Congress was compelled to pass legislation (the Food and Drug Administration Administration Act [FDAAA] of 2007) to help correct this unintentional impact on generic drug, 505(b)(2) NDAs, and biosimilar approvals. However, the changes made by the FDAAA were not sufficient to correct the problem.Therefore, in 2012, Congress passed another piece of legislation, the Food and Drug Administration Safety and Innovation Act (FDASIA), that contained provisions that modified section 505(q) of the FDAAA to further describe how the FDA is to treat these so called 505(q) petitions.
Every year, the FDA is required to submit a report to Congress to describe and provide the following information:
- The number of abbreviated new drug applications (ANDAs), 505(b)(2) applications, and biosimilar biological product applications approved during the reporting period;
- The number of such applications that were delayed by 505(q) petitions;
- The number of days by which the applications were delayed; and
- The number of 505(q) petitions that were submitted during the reporting period.
The report goes on to state:
During the fiscal year (FY) 2015 reporting period, FDA approved 492 ANDAs, 45 505(b)(2) applications, and 1 biosimilar biological product application. No approvals for biosimilar biological product applications were delayed because of a 505(q) petition in this reporting period. The approval of one ANDA was delayed because of two 505(q) petitions, and the approval of one 505(b)(2) application was delayed because of one 505(q) petition. During FY 2015, FDA received 15 505(q) petitions.
Thus one can see that the statutory provisions already enacted to correct the potential for delay of approval of any of these types of applications has worked to a certain extent, however one could also say that the delay of approval of any one application (unless truly justified) is one too many!
However, the issue clearly remains a problem for FDA as they must respond in specific timeframes to 505(q) petitions (see below). In addition, these responses often take a substantial amount of Agency resources. The rate of success of these petitions is very low. FDA reports that, from 2008 through 2015 (the last reporting period), the Agency has received 167 505(q) petitions and “as of September 30, 2015, 114 of the petitions (approximately 68 percent) responded to under section 505(q) have been denied. Another 41 petitions (approximately 25 percent) have been denied in part and granted in part. Only 8 petitions (approximately 5 percent) have been granted. An additional 4 petitions (approximately 2 percent) were voluntarily withdrawn by the petitioner.”
The Agency concludes that it is “concerned that section 505(q) may not be discouraging the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues. The statute requires FDA to prioritize these petitions above other matters, such as safety petitions, that do raise important public health concerns. As a result, FDA remains concerned about the resources required to respond to 505(q) petitions within the 150-day deadline at the expense of completing the other work of the Agency.”
The complete report can be found here. We wonder if Congress is still as concerned as FDA and whether that concern could translate into additional legislation to address this issue?