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[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This legislation streamlines the outdated over-the-counter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.
____________________