Significant amendments to the Food and Drugs Act
("FDA"), commonly referred to as "Vanessa's
Law", became law in November, 2014. Many of those
amendments will likely be accompanied by amendments to the Food
and Drug Regulations in due course. In the interim,
Health Canada has issued draft guidelines for interpreting some of
the amendments to the FDA (the "Draft Guidelines"), and
is seeking comments from stakeholders in respect of those Draft
Guidelines by June 8, 2015. Although Health Canada states
that the Draft Guidelines are already in use, feedback from
stakeholders in respect of the Draft Guidelines is important, as
the finalized version of the Draft Guidelines will likely influence
the development of future amendments to the Food and Drug
The recent amendments to the FDA include a variety of changes in
respect of therapeutic products (e.g. prescription and
non-prescription drugs, medical devices, blood and blood products,
and vaccines, but excluding natural health products), and include
granting the Minister of Health:
the power to require information, tests or studies;
the power to require a label change/package modification;
the power to require a recall of an unsafe therapeutic
the ability to disclose information in certain circumstances;
the power to apply tougher consequences for those who do not
comply with the FDA and regulations.
In addition, the amendments also require mandatory reporting of
serious ADRs and medical device incidents by healthcare
As a result, the amendments have a wide-ranging and significant
impact on all entities in the drug and medical device supply
The Draft Guidelines are directed to establishing principles to
guide all decisions made by Health Canada, and particularly in
respect of providing factors in relation the Minister's ability
to make use of the new powers, as well as to whom these powers
apply. The Draft Guidelines are significant and unusual in
that they set out the process for Health Canada to follow when
applying the new powers under the FDA.
By way of illustration, new section 21.1(1) of the FDA provides
21.1 (1) If the Minister believes that a therapeutic product may
present a serious risk of injury to human health, the Minister may
order a person to provide the Minister with information that is in
the person's control and that the Minister believes is
necessary to determine whether the product presents such a
The Draft Guidelines provide greater detail in respect of, for
example, the threshold required for the Minister to use this power,
and where the source of the information (e.g. pre- or post-market
studies, such as clinical trial applications, additional studies
submitted as part of terms and conditions place on a market
authorization, serious ADR reporting from manufacturers, patients
or healthcare institutions, and reports in the medical literature).
Although the term "serious risk" is not defined in
the FDA, the Draft Guidelines provide some non-exhaustive elements
that should be considered in assessing whether a therapeutic
product presents a serious risk of injury to human health (e.g. the
seriousness of the adverse health consequence, the vulnerability of
the patient population, such as the elderly or children, and the
extent and impact of the population's exposure).
The Draft Guidelines further elaborate that new section 21.1(1)
of the FDA cannot be used by the Minister to order a person to
create new information, such as conducting new analyses or studies,
or to seek out information from another source.
The Draft Guidelines also set out the process in respect of the
Minister issuing an order under the amendments to the FDA.
For example, although the Minister is not obliged to, the
Draft Guidelines indicate that the Minister should, prior to
issuing an order, notify the person believed to have information in
their control, and provide the person with a reasonable opportunity
to respond (e.g. allow the person an opportunity to correct an
error in fact, dispute the case against him, or voluntarily comply
with the notification).
Similar guidance to that set out above, in respect of new
section 21.1(1) of the FDA, is included in the Draft Guidelines in
respect of: the Minister's ability to disclose confidential
business information about a therapeutic product (i.e. new section
21.1(2) and (3) of the FDA); the Minister's ability to order a
label change or package modification (i.e. new section 21.2 of the
FDA); and the Minister's ability to order a recall of a
therapeutic product (i.e. new section 21.3 of the FDA).
As mentioned, Health Canada is seeking feedback, by June 8,
2015, in respect of the Draft Guidelines.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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