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# Woodcock Urges Changes to Petitions, 180-day Exclusivity
- URL: https://www.fdaweb.com/woodcock-urges-changes-to-petitions-180-day-exclusivity/
- Published: 2019-06-19T12:00:00.000Z
- Updated: 2026-09-15T01:33:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144379

FDA is asking Congress for statutory improvements to its citizen petitions process. In a 6/19 Senate Committee on Aging hearing on drug prices, CDER director **Janet Woodcock** said that FDA would like “greater authority to summarily deny petitions submitted with the primary purpose of delaying approval of an application and to incentivize timely filing of petitions. We would also like to eliminate the mandatory 150-day response timeframe from the statute. Operationally, the mandatory response timeframe is no longer needed to avoid delay of approval of follow-on applications as FDA already works under the goal dates set for these applications separate from this mandatory 150-day period.”

Woodcock’s [testimony](https://www.aging.senate.gov/imo/media/doc/SCA%5FFDA%5FWoodcock%5F06%5F19%5F19.pdf?ref=fdaweb.com) also offered two other legislative proposals to encourage competition, but with a focus on the 180-day exclusivity available to ANDA first-filers. “First, we propose that Congress amend one of the existing 180-day forfeiture provisions to limit the ability of first filers with deficient ANDAs to game the system to avoid forfeiture,” she said. “Forfeiture occurs under this provision when an applicant fails to receive tentative approval within 30 months, unless the failure to obtain tentative approval is caused by a change in or a review of the requirements for approval imposed after the application filing date.”

Woodcock contended that as it works now, first applicants with deficient applications can benefit from this provision by avoiding forfeiture even when they have deficiencies in their submissions unrelated to any change in or review of the requirements for approval. She said the agency proposes to “clarify that the exception to forfeiture will only apply if the change in or review of the requirements for approval was the sole cause of the applicant’s failure to obtain tentative approval.”

Another proposal raised by Woodcock would address “situations we see on a recurring basis where, after patent and exclusivity issues with the innovator drug have been resolved, first filers park their 180-day exclusivity and do not seek final approval, thereby delaying marketing and blocking competition for periods beyond which Congress envisioned. We suggest statutory modifications to trigger the start of the 180-day clock when: (**1**) a subsequent filer is ready for approval and the only barrier to final approval of the subsequent filer’s application is a first filer’s eligibility for 180-day exclusivity; and (**2**) certain other conditions are met, including that the first filer is past the 30-month timeframe to receive tentative approval and that any statutory stay of approval for the first filer has expired or terminated.”

The hearing came one day after the agency announced it is enhancing the Paragraph 4 patent certification list by adding several additional data points, including the status of any 180-day exclusivity decisions for individual drug products and information about the dates of first approval, marketing status, and expiration dates of blocking patents. FDA acting commissioner **Ned Sharpless** [said](https://www.fda.gov/news-events/press-announcements/statement-new-effort-improve-transparency-and-predictability-generic-drug-applicants-help-increase?ref=fdaweb.com) that adding the information “may help subsequent generic drug applicants determine when their products can be approved and marketed.”  
  
According to Sharpless, the update may allow generic applicants to make more informed business decisions about which of their specific generic drug applications have a higher likelihood of being approved sooner. And he says including the new data “may also provide more public transparency into instances in which FDA approved an ANDA with exclusivity, but the generic product is not marketed for an extended time which, among other reasons, may signal ‘gaming’ tactics in the generics market.