[Congressional Record Volume 165, Number 46 (Thursday, March 14, 2019)]
[Senate]
[Pages S1893-S1894]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                                H.R. 269

  Mr. BRAUN. Mr. President, I ask unanimous consent that the following 
letter be printed in the Congressional Record.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                                  U.S. Senate,

                                                   March 14, 2019.
     Hon. Mitch McConnell,
     Senate Majority Leader,
     U.S. Senate, Washington, DC.
       Dear Leader McConnell, I am requesting to be consulted 
     before the Senate enters into any unanimous consent 
     agreements or time limitations regarding H.R. 269, the Over-
     the-Counter Drug Safety, Innovation, and Reform Act. I 
     further request that this legislation not be incorporated 
     into any larger legislative vehicles that the Senate as a 
     whole may consider until the concerns I describe below are 
     fully addressed.
       This legislation streamlines the outdated over-the-counter 
     (OTC) drug approval process at the U.S. Food and Drug 
     Administration (FDA)--a process originally developed in 1972. 
     Specifically, the legislation allows the FDA to approve OTC 
     versions of prescription drugs administratively, rather than 
     going through the lengthy notice-and comment-rulemaking 
     procedures under the Administrative Procedure Act. The 
     legislation also encourages more innovation and investment in 
     the OTC space by providing an 18-month market-exclusively 
     component that rewards a return on investment for new OTC 
     drugs. The 18-month market exclusivity period is crucial to 
     creating a thriving OTC drug market; however, H.R. 269 does 
     not contain adequate oversight mechanisms to ensure that this 
     exclusivity provision is not abused by some OTC drug 
     manufacturers after the reforms of H.R. 269 are implemented 
     by the FDA.
       Although the legislation encourages more innovation and 
     investment in the OTC space, it does not include any 
     conditions under which an OTC drug manufacturer would forfeit 
     eligibility for the 18-month exclusivity

[[Page S1894]]

     period. For example, there is no ``failure to market'' 
     provision for OTC drug approvals in the legislation similar 
     to the provisions applying to generic drugs under Hatch-
     Waxman to prevent OTC drug manufacturers, who can otherwise 
     enter the market, from refraining to do so (a practice called 
     exclusivity parking).
       Anti-competitive behavior--like exclusivity parking--has 
     disrupted the generic drug industry. In fact, exclusivity 
     parking has become common in the context of patent litigation 
     settlement agreements where proprietary drug manufacturers 
     pay generic drug manufacturers to delay entering the market, 
     allowing proprietary drug manufacturers to charge higher 
     prices for long periods of time (i.e. pay-for-delay 
     settlements). The Federal Trade Commission has estimated that 
     this behavior costs consumers $3.5 billion per year as a 
     result of higher brand-name drug prices. And even though the 
     process for obtaining OTC drug approval under H.R. 269 is 
     more straightforward than that for obtaining market approval 
     for a generic drugs--anti-competitive behavior (e.g., 
     exclusivity parking) may creep into the OTC drug space if 
     Congress fails to include sufficient oversight mechanisms in 
     the legislation to ensure adequate accountability and 
     effective competition.
       Modernizing the OTC drug approval process under H.R. 269 
     will benefit consumers and advance the public health; 
     however, H.R. 269 as currently drafted does not give the FDA 
     the necessary oversight tools to ensure accountability in the 
     OTC space. Including a ``failure to launch'' provision in 
     H.R. 269--that is, a mechanism that gives an OTC drug 
     manufacturer a reasonable amount of time to bring an FDA 
     approved OTC product to market--will protect the incentive to 
     innovate and invest, while also providing adequate 
     accountability. Indeed, to ensure effective competition in 
     the OTC space, Congress must provide the FDA with the 
     necessary oversight tools to prevent abuse of the OTC 
     regulatory approval process under the reforms of H.R. 269.
       Thank you for protecting my rights as a Senator to weigh in 
     on this legislation, which has not gone through regular order 
     during my time as a member of the Committee to which this 
     legislation has been referred to in the 116th congress.
           Sincerely,
                                                       Mike Braun,
     United States Senator.

                          ____________________