FDA Law Blog: New Legislation Seeks to Incentivize OTC Status for Contraceptives by Granting Priority Review and Waiving PDUFA Application User Fee

FDA Law Blog: New Legislation Seeks to Incentivize OTC Status for Contraceptives by Granting Priority Review and Waiving PDUFA Application User Fee

New Legislation Seeks to Incentivize OTC Status for Contraceptives by Granting Priority Review and Waiving PDUFA Application User Fee

Posted: 27 May 2015 09:53 PM PDT

By Kurt R. Karst –     

We like simplicity.  After all, it is, as Leonardo da Vinci reportedly once said, “the ultimate sophistication.”  We also like simple FDA-related legislation; but that’s not something we see all too often.  (We also don’t often see legislation addressing Prescription-to-Over-the-Counter (“Rc-to-OTC”) switches.)  Last week, however, a bill was introduced in the U.S. Senate by Senators Kelly Ayotte (R-NH) and Cory Gardner (R-CO) – S. 1438, the Allowing Greater Access to Safe and Effective Contraception Act – that provides an elegant remedy to a perceived problem.  As explained in a press release announcing the introduction of S. 1438:

The FDA has found a number of contraceptives to be proven safe and effective at preventing pregnancies and managing certain health conditions.  However, in order to access safe and effective contraceptives designed for routine use, currently a woman must visit her health care provider to receive a prescription.  The Allowing Greater Access to Safe and Effective Contraception Act would encourage manufacturers of routine-use contraceptives to file an application with the FDA to switch their products from prescription to OTC.  This legislation would not interfere with the FDA’s current process for determining safety and efficacy, maintaining FDA scientists’ and experts’ authority to make the final decision on whether a contraceptive should be made available OTC.

So what does the bill say, specifically?  Here are the few lines relevant to the FDC Act (Another section of S. 1438 would repeal the Affordable Care Act’s restriction on the use of health, medical and flexible savings accounts to buy OTC drugs without a prescription.):

(a) PRIORITY REVIEW OF APPLICATION.—Thc Secretary of Health and Human Services. . . shall give priority review to any supplemental application submitted under [FDC Act § 505(b)] for a contraceptive drug, provided that—

(1) the supplemental application is with respect to a drug intended for routine use; and

(2) if the supplemental application is approved, with respect to individuals aged 18 and older, such drug would not be subject to [FDC Act § 503(b)(1) concerning prescription status].

(b) FEE WAIVER.—The Secretary shall waive the [application user] fee under [FDC Act § 736(a)(1)] with respect to a supplemental application that receives priority review under subsection (a).

(c) OVER-THE-COUNTER AVAILABILITY.—Notwithstanding any other provision of law, with respect to individuals under age 18, a contraceptive drug that is eligible for priority review under subsection (a) shall be subject to [FDC Act § 503(b)(1)].

Although FDA’s preferred path for a partial Rx-to-OTC switch is the submission of a new NDA (and an NDA supplement for a full Rx-to-OTC switch), S. 1438 recognizes the supplemental pathway used for the partial Rx-to-OTC switch of PLAN B (levonorgestrel) Tablets a few years ago (see our previous posts here and here).

More interesting, however, is the significant benefit S. 1438 would confer to Rx-to-OTC switch applicants with a few strokes of the pen.  Priority review is a highly sought-after commodity.  Indeed, there are separate statutory provisions creating transferable priority review vouchers, such as the rare pediatric disease priority review voucher (FDC Act § 529) (see our previous post here), and the tropical disease priority review voucher (FDC Act § 524) (see our previous post here).  And in each of those programs, a special priority review voucher application user fee must be paid (in addition to other applicable user fees).  While S. 1438 would not create a transferable priority review voucher, the benefit is nothing to sneeze at.  After all, companies pay hundreds of millions of dollars to obtain priority review stats.  In fact, earlier this week, it was announced that Sanofi agreed to pay $245 million in cash for a rare pediatric disease priority review voucher FDA granted to another company a little more than two months ago (see our previous post here).  That’s a lot of dineros!