LS&HC Horizons 2022 - Flipbook - Page 33
Hogan Lovells | 2022 Life Sciences and Health Care Horizons
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Covid-19 and Pandemic Preparedness
Over-the-counter and home use diagnostic testing – A brave new world for patient care
Over-the-counter (OTC) assays are tests sold directly to the consumer,
for use at home, and do not require a physician prescription. During
the Covid pandemic, both rapid antigen and molecular tests have
been authorized for emergency use as OTC tests, and have played
an important role in helping manage patient care. Other kinds of
diagnostic tests (such as include glucose monitoring devices, drugs of
abuse tests, cholesterol tests, and pregnancy and ovulation tests) are
not OTC devices, require a prescription, but can still be used at home.
As technology has advanced and assays have become more accurate,
patients have asked for and companies have been developing more
tests for use in home environments, especially for infectious diseases
and chronic conditions where testing has historically been performed
only by prescription and in clinical laboratories. The public health
successes of OTC Covid tests has highlighted the technical feasibility
of OTC testing and increased the public’s interest. Patients are seeking
more active participation in their health care. Given the growing trend
of telemedicine and interest in home testing, we expect an increasing
number of OTC and at home tests for a wide variety of infectious
diseases and other conditions.
Manufacturers need to be strategic in developing tests and engage
with FDA early to align with FDA’s expectations and concerns.
Companies will need to follow the evolving regulatory environment
and standards, and help shape developing regulatory standards to
advance home diagnostics, to meet the growing consumer need.
Randy Prebula
Partner, Washington, D.C.
Susan Tiedy-Stevenson
Senior Director, Washington, D.C.
