DUBLIN and ALLEGAN,
Mich., July 11, 2022 /PRNewswire/ -- Perrigo
Company plc (NYSE: PRGO), a leading global provider of Consumer
Self-Care Products, today announced that HRA Pharma, a Perrigo
company, has submitted its application to the United States Food
and Drug Administration (FDA) for the first-ever over-the-counter
(OTC) birth control pill in the United
States.
The company has applied for an Rx-to-OTC switch for
Opill®, a progestin-only daily birth control pill
(also referred to as a mini pill or non-estrogen pill). If
approved, this would be the first daily birth control pill
available OTC without a prescription in the U.S.
"This historic application marks a groundbreaking moment in
contraceptive access and reproductive equity in the U.S.," said
Frédérique Welgryn, Chief Strategic Operations and Innovation
Officer at HRA Pharma. "More than 60 years ago, prescription
birth control pills in the U.S. empowered women to plan if and when
they want to get pregnant. Moving a safe and effective prescription
birth control pill to OTC will help even more women and people
access contraception without facing unnecessary barriers."
Almost half of the more than 6.1 million pregnancies in the U.S.
each year are unintended1. Access to a range of methods
and ways to access contraception that meet people's needs will
increase the likelihood of using effective birth control
methods.
Major medical organizations, including the American College of
Obstetricians and Gynecologists, the American Medical Association,
and the American Academy of Family Physicians, have expressed
support for moving birth control pills OTC.
Opill® consists of 0.075 mg norgestrel and has been
used to prevent pregnancy in millions of women in the U.S. since it
was FDA approved in 1973. Nearly fifty years of use and scientific
evidence show that progestin-only pills like Opill® are
effective at preventing pregnancy and are safe 2,3 for
most women to use. As a daily regular contraceptive,
Opill® is to be used pre-conception to be effective at
preventing pregnancy.
Nearly one-third of adult U.S. women who have ever tried to
obtain a prescription or refill for contraceptive pill, patch, or
ring reported difficulties doing so4.
Removing the prescription requirement with Opill®
would improve access to a contraceptive method that is well
tolerated and notably more effective at preventing pregnancy than
all current methods available OTC.
"As a doctor, I am dedicated to empowering people to make
decisions about pregnancy prevention. For many, a birth control
pill may be the best option for them but requiring a prescription
is an unnecessary obstacle that can put it out of reach," said
obstetrician-gynecologist, Melissa J.
Kottke, MD, MPH, MBA. "Removing the prescription
requirement for a progestin-only birth control pill will be a
historic advancement for pregnancy prevention and a remarkable
achievement in community public health."
- Finer LB, Zolna MR. Declines in unintended pregnancy in
the United States, 2008–2011. N
Engl J Med. 2016;374:843-852
- White K, Potter JE, Hopkins K, Fernandez L, Amastae J, Grossman
D. Contraindications to progestin-only oral contraceptive pills
among reproductive-aged women. Contraception 2012;
86(3):199-203
- American College of Obstetricians and Gynecologists.
Over-the-counter access to hormonal contraception: ACOG committee
opinion, Number 788. Obstet Gynecol 2019;134(4):e96-e105
- Grindlay K, Grossman D. Prescription birth control access among
U.S. women at risk of unintended pregnancy. J Womens Health.
2016;25(3):249-254
About Perrigo
Perrigo Company plc (NYSE; PRGO) is a leading provider of
Consumer Self-Care Products and over-the-counter (OTC)
health and wellness solutions that enhance individual well-being by
empowering consumers to proactively prevent or treat conditions
that can be self-managed. Visit Perrigo online at
www.perrigo.com.
Forward-Looking Statements
Certain statements in this press release are "forward-looking
statements." These statements relate to future events or the
Company's future financial performance and involve known and
unknown risks, uncertainties and other factors that may cause the
actual results, levels of activity, performance or achievements of
the Company or its industry to be materially different from those
expressed or implied by any forward-looking statements. In some
cases, forward-looking statements can be identified by terminology
such as "may," "will," "could," "would," "should," "expect,"
"forecast," "plan," "anticipate," "intend," "believe," "estimate,"
"predict," "potential" or the negative of those terms or other
comparable terminology. The Company has based these forward-looking
statements on its current expectations, assumptions, estimates and
projections. While the Company believes these expectations,
assumptions, estimates and projections are reasonable, such
forward-looking statements are only predictions and involve known
and unknown risks and uncertainties, many of which are beyond the
Company's control, including: the effect of the coronavirus
(COVID-19) pandemic and its variants and associated supply chain
impacts on the Company's business; general economic, credit, and
market conditions; the impact of the war in Ukraine and any escalation thereof, including
the effects of economic and political sanctions imposed by
the United States, United Kingdom, European Union, and other
countries related thereto; the outbreak or escalation of conflict
in other regions where we do business; future impairment charges;
customer acceptance of new products; competition from other
industry participants, some of whom have greater marketing
resources or larger market shares in certain product categories
than the Company does; pricing pressures from customers and
consumers; resolution of uncertain tax positions, including the
Company's appeal of the draft and final Notices of Proposed
Assessment ("NOPAs") issued by the U.S. Internal Revenue Service
and the impact that an adverse result in any such proceedings would
have on operating results, cash flows, and liquidity; pending and
potential third-party claims and litigation, including litigation
relating to the Company's restatement of previously-filed financial
information and litigation relating to uncertain tax positions,
including the NOPAs; potential impacts of ongoing or future
government investigations and regulatory initiatives; potential
costs and reputational impact of product recalls or sales halts;
the impact of tax reform legislation and/or changes in healthcare
policy; the timing, amount and cost of any share repurchases;
fluctuations in currency exchange rates and interest rates; the
Company's ability to achieve the benefits expected from the sale of
its Rx business and the risk that potential costs or liabilities
incurred or retained in connection with the transaction may exceed
the Company's estimates or adversely affect the Company's business
or operations; the Company's ability to achieve the benefits
expected from the acquisition of HRA Pharma and the risks that the
Company's synergy estimates are inaccurate or that the Company
faces higher than anticipated integration or other costs in
connection with the acquisition; risks associated with the
integration of HRA Pharma, including the risk that growth rates are
adversely affected by any delay in the integration of sales and
distribution networks; the consummation and success of other
announced and unannounced acquisitions or dispositions, and the
Company's ability to realize the desired benefits thereof; and the
Company's ability to execute and achieve the desired benefits of
announced cost-reduction efforts and strategic and other
initiatives. An adverse result with respect to the Company's appeal
of any material outstanding tax assessments or pending litigation,
including securities or drug pricing matters, could ultimately
require the use of corporate assets to pay such assessments,
damages from third-party claims, and related interest and/or
penalties, and any such use of corporate assets would limit the
assets available for other corporate purposes. These and other
important factors, including those discussed under "Risk Factors"
in the Company's Form 10-K for the year ended December 31, 2021, as well as the Company's
subsequent filings with the United States Securities and Exchange
Commission, may cause actual results, performance or achievements
to differ materially from those expressed or implied by these
forward-looking statements. The forward-looking statements in this
press release are made only as of the date hereof, and unless
otherwise required by applicable securities laws, the Company
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events, or otherwise.
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SOURCE Perrigo Company plc