31
Lifecycle Management Through the Rx-to-OTC Switch
Introduction
In the US, most new chemical entities developed
to treat, cure, or mitigate disease are approved
and commercialized as prescription drug
products. Under this scenario, a healthcare pro-
fessional (HCP), usually a medical doctor, will
diagnose the patient and based on the patient’s
health history, determine the best treatment to
safely and efficaciously address the health issue.
The HCP also may instruct the patient on how
to use or administer the drug, what to do if
certain side effects arise, how to handle a missed
dose, whether the drug can safely be used during
pregnancy, etc.
When it has been demonstrated that a drug
can be used safely and efficaciously without a
learned intermediary, such as a HCP, FDA will
consider making the drug available without a pre-
scription. In most cases, the drug has already been
available by prescription thus, we refer to this
process as an Rx-to-OTC switch. In certain cases,
new chemical entities have been approved directly
as over-the-counter (OTC) products, which is
considered direct-to-OTC the most notable case
of a direct-to-OTC approval is Abreva.
When considering an Rx-to-OTC switch,
FDA is most interested in how the benefit-risk
ratio will shift when the learned intermediary
is removed from the equation. Often, the risk is
dependent on how consumers will behave and
make decisions based on the information provided
on the Drug Facts label (DFL). There are several
standard consumer behavior and clinical studies
on which FDA relies for assessing the impact of a
proposed Rx-to-OTC paradigm change.
Approval of an Rx-to-OTC switch requires
filing a new or supplemental NDA, which is
then reviewed according to a standard 10-month
time clock established by the Prescription Drug
User Fee Act (PDUFA). For first-in-class Rx-to-
OTC switches, FDA may convene an Advisory
Committee meeting prior to making a final
determination about OTC approval.
A Quick History of OTC Drugs
In 1951, the Pure Food and Drug Act of 1906
was amended with the passage of the Durham-
Humphrey Amendment, also known as the
Federal Food, Drug and Cosmetic Act. The
Durham-Humphrey Amendment explicitly
defined two categories of medications: legend
(prescription) and OTC. Until this time, man-
ufacturers were allowed to determine whether
there were restrictions on the distribution of
their drugs.
The bill defined the kinds of medications
that cannot be used safely without medical super-
vision, such as those drugs that are habit-forming
or could be potentially harmful. All other drugs
were to be available without a prescription.
In 1972, FDA began the OTC Drug Review
process “to enhance the safety, effectiveness, and
appropriate labeling of drugs sold without pre-
scription.”1 Under this process, FDA requested
that OTC drug manufacturers submit data to
What is the Rx-to-OTC switch
process in the US and how does
FDA regulate switches?
By Susan B. Levy
3
Lifecycle Management Through the Rx-to-OTC Switch
Introduction
In the US, most new chemical entities developed
to treat, cure, or mitigate disease are approved
and commercialized as prescription drug
products. Under this scenario, a healthcare pro-
fessional (HCP), usually a medical doctor, will
diagnose the patient and based on the patient’s
health history, determine the best treatment to
safely and efficaciously address the health issue.
The HCP also may instruct the patient on how
to use or administer the drug, what to do if
certain side effects arise, how to handle a missed
dose, whether the drug can safely be used during
pregnancy, etc.
When it has been demonstrated that a drug
can be used safely and efficaciously without a
learned intermediary, such as a HCP, FDA will
consider making the drug available without a pre-
scription. In most cases, the drug has already been
available by prescription thus, we refer to this
process as an Rx-to-OTC switch. In certain cases,
new chemical entities have been approved directly
as over-the-counter (OTC) products, which is
considered direct-to-OTC the most notable case
of a direct-to-OTC approval is Abreva.
When considering an Rx-to-OTC switch,
FDA is most interested in how the benefit-risk
ratio will shift when the learned intermediary
is removed from the equation. Often, the risk is
dependent on how consumers will behave and
make decisions based on the information provided
on the Drug Facts label (DFL). There are several
standard consumer behavior and clinical studies
on which FDA relies for assessing the impact of a
proposed Rx-to-OTC paradigm change.
Approval of an Rx-to-OTC switch requires
filing a new or supplemental NDA, which is
then reviewed according to a standard 10-month
time clock established by the Prescription Drug
User Fee Act (PDUFA). For first-in-class Rx-to-
OTC switches, FDA may convene an Advisory
Committee meeting prior to making a final
determination about OTC approval.
A Quick History of OTC Drugs
In 1951, the Pure Food and Drug Act of 1906
was amended with the passage of the Durham-
Humphrey Amendment, also known as the
Federal Food, Drug and Cosmetic Act. The
Durham-Humphrey Amendment explicitly
defined two categories of medications: legend
(prescription) and OTC. Until this time, man-
ufacturers were allowed to determine whether
there were restrictions on the distribution of
their drugs.
The bill defined the kinds of medications
that cannot be used safely without medical super-
vision, such as those drugs that are habit-forming
or could be potentially harmful. All other drugs
were to be available without a prescription.
In 1972, FDA began the OTC Drug Review
process “to enhance the safety, effectiveness, and
appropriate labeling of drugs sold without pre-
scription.”1 Under this process, FDA requested
that OTC drug manufacturers submit data to
What is the Rx-to-OTC switch
process in the US and how does
FDA regulate switches?
By Susan B. Levy
3