Woodcock Offers 180-Day Exclusivity Tweaks as Senate Committee Preps for Vote
The Senate health committee said it plans to vote on a wide-ranging bill with implications for the US Food and Drug Administration (FDA) next Wednesday and Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, laid out FDA’s views on several proposals at a Senate Aging Committee hearing on Wednesday.The bipartisan bill from the committee mirrors a discussion draft released in May and includes a new section that would give FDA new authorities to address outdated generic drug labeling because there is no longer a reference product on the market. FDA’s Oncology Center of Excellence (OCE) is already working with industry to update generic chemotherapy labels in such circumstances.
And just a day after FDA announced it’s releasing new data to help generic companies better understand 180-day exclusivity determinations, Woodcock offered two proposals to tweak 180-day forfeiture provisions and modify when to start the 180-day clock.
“First, we propose that Congress amend one of the existing 180-day forfeiture provisions to limit the ability of first filers with deficient ANDAs [abbreviated new drug applications] to game the system to avoid forfeiture. 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’s written testimony says.
“Currently, first applicants with deficient applications may benefit from this provision by avoiding forfeiture even though they have deficiencies in their application unrelated to any change in or review of the requirements for approval. The proposal would 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,” she adds.
The second proposal would address situations Woodcock said FDA sees “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.”
To improve this issue, FDA suggests statutory changes 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 committee bill would prevent first-to-file generic drug applicants from blocking, beyond a 180-day exclusivity period, the entrance of subsequent generic drugs to the market. And it would trigger the start of first-to-file generic drug applicants’ 180-day exclusivity when a subsequent applicant has been tentatively approved and no first-to-file applicant has received final approval within 33 months of its ANDA submission.
Citizen petitions are another area where 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,” Woodcock’s testimony says. The committee bill contains several provisions to address abuses of the citizen petition process.
And Woodcock also reiterated the agency’s interest in reforming the over-the-counter (OTC) drug monograph process, noting that the current system “is stuck in the 1970s” and does not allow for innovation. Senate health committee chair Lamar Alexander (R-TN) reportedly told Sen. Robert Casey (D-PA) on Tuesday that he is committed to finding a path forward for monograph reform legislation. The House passed a bill to reform the OTC monograph system last July.
Sen. Martha McSally (R-AZ) also questioned Woodcock on why biosimilars are winning approval but not actually coming to market. But Woodcock said FDA does not have total visibility into what companies do.
“I’m aware that they’re caught up in patent disputes, but we’re not fully clear on the various reasons for not reaching the market,” Woodcock said.