Health Product Advertising on Physician Websites

Recently, Health Canada wrote to the registrars of the provincial medical regulatory authorities about physicians promoting health products on their Web sites. They have received complaints about this practice (direct-to-consumer advertising of prescription drugs) and are providing guidance to help physicians comply with federal advertising requirements.

• Section 9(1): Prohibits health product advertising which is false, misleading or deceptive, or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Examples of possible section 9(1) contraventions: messages which emphasize only product benefits without including safety information; and messages discussing off-label use of a product.
• Section 20(1): Prohibits false, misleading or deceptive advertising of medical devices.
• Section 3(1): Prohibits consumer-directed ads for health products (including medical devices) which make claims to treat, prevent or cure any of the serious diseases listed in Schedule A to the Act (although Schedule A prevention claims are now permitted by regulation for over-the-counter drugs and natural health products).

Food and Drug Regulations 

• Section C.01.044: Prohibits consumer-directed prescription drug advertising beyond the drug’s name, price and quantity. This means, for example, that when a prescription drug is advertised by name to consumers, no reference can be made to its therapeutic use and/or benefits.
• Section C.08.002 (1): Prohibits the advertising of new drugs which have not been authorized for sale by Health Canada.

NMI Labelling Disclosure for Drug Products

Until now, the drug framework in Canada has been one of the few regulatory frameworks which does not require full-ingredient disclosure on product labels. Health Canada has made several attempts to bring requirements for non-medicinal ingredient labelling into force but has never been successful, until now.

Regulatory Requirement for Non-Medicinal Ingredient (NMI) Labelling are expected to take effect May 12, 2012.

Health Canada has released several Informational guidance documents on their website this week regarding the upcoming Non-Medicinal Ingredient (NMI)listing requirements.  These requirements will apply to most drug products intended for human use. Prescription drugs, non-prescription drugs only administered under the supervision of a health care practitioner, low level disinfectants (hard surface) and Veterinary Drugs will be exempt from these requirements.

Manufacturers/Sponsors will be required to submit a letter of attestation to Health Canada to certify that their products meet the NMI regulations and their expected date of compliance.  Health Canad has already included notifications regarding these requirements in the Annual Drug Notifications which are currently being sent out to Submission Sponsors.

Reconsideration Process through NHPD

Many companies are finding that NHPD is increasingly issuing Notices of Refusal (NOR) to shorten their review queue.

What happens if you receive a Notice of Refusal?  You have a few options.  You can either accept the refusal, re-file your submission, or you can challenge the NOR via NHPD's Reconsideration Process.

A Refusal Letter contains the specific reasons or deficiencies that resulted in NHPD's decision to refuse issuance or amendment of a Product Licence. The purpose of a request for reconsideration is to allow the NHPD and a Submission Sponsor to discuss issues related to a Directorate decision on an application.

The parties may clarify and justify their positions using information that was available to the NHPD when the decision was made. NHPD will allow the applicant to clarify his or her position. However NHPD will not engage in any discussion or debate over the notice of refusal. 

NHPD will review your request for reconsideration and then make a final determination as to whether or not the submission can be reinstated and eventually proceed for successful licensing.    This is the last opportunity to convince NHPD that the submission has merit. If you don't file an appeal or the appeal is unsuccessful, it is important to note that any exemption numbers are withdrawn and you can no longer sell your product in Canada.  Therefore it is crucial that applicants file a strong appeals package to support their request for reconsideration.   On behalf of our clients, DSA Consultants have been very successful in forcing NHPD to overturn the decision to refuse a submission, an then have the same submissions go on to successful licensing.  It is important for industry to note that not all NHPD Submission Refusals are with merit.

How can you approach NHPD?  Do you have the basis for appeal?  At DSA Consultants, we understand how frustrated and confusing this process can be. Our team of Regulatory Consultants will guide you through the Reconsideration Process and act as your Representative with NHPD. For more information on this or other services offered by DSA Consultants, contact info@dsaconsultants.com.