Vol. 138, No. 47 — November 20, 2004

Regulations Amending the Food and Drug Regulations (1330 — Sibutramine)

Statutory authority

Food and Drugs Act

Sponsoring department

Department of Health

REGULATORY IMPACT
ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

The Therapeutic Products Directorate (TPD) of Health Canada proposes to update Schedule F to the Food and Drug Regulations of the Food and Drugs Act by adding the medicinal ingredient sibutramine and its salts to Part I of Schedule F.

Schedule F is a list of medicinal ingredients, the sale of which are controlled specifically under sections C.01.041 to C.01.049 of the Regulations. Part I of Schedule F lists medicinal ingredients that, when contained in a drug, are sold on prescription for both human and veterinary use. The review and introduction of new drugs onto the Canadian market require periodic revisions to Schedule F.

Part G of the Regulations defines and provides an appropriate level of control for controlled drugs, which are drugs that have a significant abuse potential. These Regulations require dealers to be licensed in order to produce, manufacture, distribute, import and export these drugs. Licensed dealers must meet security requirements and obtain permits to import and export controlled drugs. These Regulations restrict the distribution activities of pharmacists, hospitals and practitioners and outline the records which must be kept for these drugs. The Schedule to Part G is a list of controlled drugs.

The Controlled Drugs and Substances Act (CDSA) limits the possession, import, export, production, distribution and sale of narcotics, controlled drugs, targeted substances and precursor chemicals that can result in harm when distributed or used without controls. The CDSA specifies restrictions and offences that apply to drugs that are subject to abuse and illicit activity. These more stringent limits to access help to prevent the diversion of these substances for illegal purposes. The CDSA includes six schedules, each having different levels of restriction on and consequences for possession. Controlled drugs are usually listed on Schedule III or IV.

Sibutramine is an anorexiant/antiobesity drug. It is recommended for use in combination with a weight management program to aid weight loss in obese patients with an initial body mass index (BMI) of 30 kg/m² or higher. It is also recommended for use in obese patients with an initial BMI of 27 kg/m² or higher who have other risk factors (e.g. controlled hypertension, type 2 diabetes, excessive fat in the abdominal area).

The proposal to add sibutramine to Schedule F was first communicated to stakeholders as part of a list of medicinal ingredients in Schedule 1286. Responses from stakeholders included a proposal to add sibutramine to the Schedule to Part G instead of to Schedule F of the Regulations. No comments were received regarding the other 17 medicinal ingredients being proposed for addition to Schedule F. In order to allow the addition of these 17 medicinal ingredients to Schedule F to proceed without further delay, sibutramine was removed from Schedule 1286. Stakeholders were informed of this change in a letter dated May 5, 2002.

Alternatives

The options outlined below were considered in the development of this proposal.

Option 1 — Add sibutramine to Schedule F

On behalf of the Health Products and Food Branch, the Drug Schedule Status Subcommittee reviews the status of chemical entities proposed for marketing as medicinal ingredients in drug products. A decision regarding the necessity for prescription versus non-prescription status was made for the medicinal ingredient in this proposed amendment on the basis of established and publicly available criteria to determine whether this level of control over the sale of the drug is appropriate. These criteria include, but are not limited to, concerns related to toxicity, pharmacologic properties and therapeutic applications. The policy on "Factors for Listing Drugs in Schedule F" is available on the TPD Web site at http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/listschf_e.html

Considerations

•  Sibutramine is considered to meet the criteria of Schedule F factors.

•  Sibutramine has been registered as a prescription drug in 14 European Union countries.

Option 2 — Add sibutramine to the Schedule to Part G (Controlled Drugs)

During the consultation process, 11 stakeholders objected to Schedule F status for sibutramine because they believe that patients could abuse the weight-loss drug. These stakeholders made reference to a single research report studying the abuse potential of sibutramine and indicated support for this drug to be listed on the Schedule to Part G. The concerns expressed by these respondents included the abuse liability, dependency potential and lack of safety data from post-market use of sibutramine.

Part G of the Food and Drug Regulations (Part G of the Regulations) regulates the possession, sale and distribution of substances commonly referred to as Controlled Drugs.

Drugs listed in Part I of the Schedule to Part G include amphetamines, certain barbiturates and other psychoactive substances. These substances have a significant abuse potential.

Presently, sibutramine is a controlled drug in the United States and Greece; however, its status in those countries is still under discussion. In November 1997, the U.S. Food and Drug Administration (FDA) approved sibutramine as a prescription drug for the management of obesity. Based on the FDA's recommendation, in February 1998, the Drug Enforcement Administration (DEA) scheduled sibutramine, including its salts and isomers, as a controlled substance. This decision was based on certain chemical properties which may have made sibutramine open to possible experimental or recreational use. The manufacturer agreed to conduct an extensive post-marketing surveillance programme to monitor potential abuse of sibutramine in the United States, and the findings have detected no evidence of sibutramine abuse.

As a result, the manufacturer submitted a petition to the U.S. DEA to decontrol sibutramine in February 2000. A decision is pending. However, based on the studies supporting the lack of abuse potential of sibutramine, it is probable that this substance will be descheduled in the United States.

Considerations

•  A review of sibutramine has shown that it does not have the abusive tendencies that would warrant it being placed on a controlled drug schedule.

•  The Office of Controlled Substances (OCS) of the Healthy Environments and Consumer Safety Branch (HECSB) concurs with the recommendation to add sibutramine to Schedule F.

•  Addition of sibutramine to Part I of the Schedule to Part G (Controlled Drugs) of the Food and Drug Regulations would cause this substance to be regulated similarly to substances of known abuse potential. All importation, exportation, manufacture and distribution would be controlled through a system of licensing, permits, mandatory record-keeping and security.

Option 2 is not recommended for this drug. The licensing, security and record-keeping burden for distributors, pharmacies and hospitals are not warranted for a drug with such a low abuse potential.

Based on the analysis described above, option 1 was chosen. Health Canada is recommending that sibutramine be placed on Part I of Schedule F.

This recommended degree of regulatory control coincides with the risk factors associated with this substance. Advice from a medical practitioner is necessary to ensure that consumers receive adequate risk/benefit information before taking the medication.

Any alternatives to the degree of regulatory control recommended in this regulatory initiative would need to be established through additional scientific information and clinical experience.

Benefits and costs

The amendment would impact on the following sectors:

Public

Prescription access to the drugs affected by the proposed amendment would benefit Canadians by decreasing the opportunities for improper use, and by ensuring professional guidance and care.

Health insurance plans

This drug, when assigned prescription status, may be covered by both provincial and private health care plans.

Provincial health care services

The provinces may incur costs to cover physicians fees for services. However, the guidance and care provided by the physicians would reduce the need for health care services that may result from improper use of the drugs. The overall additional costs for health care services should therefore be minimal.

Consultation

The manufacturer affected by this proposed amendment was informed of the intent to recommend sibutramine for inclusion on Part I of Schedule F at the time of market authorization of the drug.

The initial proposal to add sibutramine to Part I of Schedule F was included as part of a group of medicinal ingredients in Schedule 1286. A Letter to Stakeholders regarding Schedule 1286 dated September 19, 2001, was provided by electronic mail to the Pharmaceutical Issues Committee, deans of pharmacy, registrars of medicine, registrars of pharmacy, provincial deputy ministers of health, and health and trade associations, with a 30-day comment period. This initiative was also posted on the Therapeutic Products Directorate Web site.

Comments were received from 11 stakeholders. All 11 respondents objected to the addition of sibutramine to Schedule F. These comments are addressed in the discussion above.

A 75-day comment period will be provided upon prepublication in the Canada Gazette, Part I.

Compliance and enforcement

This amendment would not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Catherine Cuerrier, Policy Division, Bureau of Policy, Therapeutic Products Directorate, Health Canada, Holland Cross, Tower B, 2nd Floor, 1600 Scott Street, Address Locator 3102C5, Ottawa, Ontario K1A 1B6, (613) 952-7316 (telephone), (613) 941-6458 (facsimile), catherine_cuerrier@hc-sc.gc.ca (electronic mail).

PROPOSED REGULATORY TEXT

Notice is hereby given that the Governor in Council, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act, proposes to make the annexed Regulations Amending the Food and Drug Regulations (1330 — Sibutramine).

Interested persons may make representations with respect to the proposed Regulations within 75 days after the date of publication of this notice. All such representations must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to Alexandra Bray, Therapeutic Products Directorate, Department of Health, Address Locator 3102C5, 1600 Scott Street, 2nd Floor, Tower B, Ottawa, Ontario K1A 1B6 (Fax: (613) 941-6458; E-mail: alexandra_bray@hc-sc.gc.ca).

Persons making representations should identify any of those representations the disclosure of which should be refused under the Access to Information Act, in particular under sections 19 and 20 of that Act, and should indicate the reasons why and the period during which the representations should not be disclosed. They should also identify any representations for which there is consent to disclosure for the purposes of that Act.

Ottawa, November 15, 2004

EILEEN BOYD
Assistant Clerk of the Privy Council

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1330 — SIBUTRAMINE)

AMENDMENT

1. Part I of Schedule F to the Food and Drug Regulations (see footnote 1) is amended by adding the following in alphabetical order:

Sibutramine and its salts
Sibutramine et ses sels

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

[47-1-o]

Footnote a

S.C. 1999, c. 33, s. 347

Footnote 1

C.R.C., c. 870

NOTICE:
The format of the electronic version of this issue of the Canada Gazette was modified in order to be compatible with hypertext language (HTML). Its content is very similar except for the footnotes, the symbols and the tables.

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