Significant amendments to the federal Food and Drugs Act (“FDA”), which are commonly referred to as “Vanessa’s Law”, became law in November, 2014. These amendments are discussed in detail in our November 13, 2014 Health Communiqué “Changes to Food and Drugs Act address Patient Safety – Passage of Vanessa’s Law“. Many of the 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 the 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 will likely influence the development of future amendments to the Food and Drug Regulations.
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 product;
- the ability to disclose information in certain circumstances; and
- 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 adverse drug reactions (“ADRs”) and medical device incidents by healthcare institutions.
As a result, the amendments have a wide-ranging and significant impact on all entities in the drug and medical device supply chain.
The Draft Guidelines are directed to establishing principles to guide all decisions made by Health Canada, 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 as follows:
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 risk.
The Draft Guidelines provide greater detail of the threshold required for the Minister to use this power, and what the source of the information is (e.g. pre- or post-market studies, such as clinical trial applications, additional studies submitted as part of terms and conditions placed 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 the 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 regarding: 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 above, Health Canada is seeking feedback, by June 8, 2015, in respect of the Draft Guidelines.