Pharmacapsules @ Gowlings - December 3, 2009

Edited by Jennifer Wilkie and Chantal Saunders

New Disclosure Requirements for Clinical Trials U.S. FDA Contemplates New Rules for Internet-Delivered Health Information Recent Cases New Disclosure Requirements for Clinical Trials

By Scott Robertson

The International Federation of Pharmaceutical Manufactures and Associations (IFPMA) has released its latest Joint Position which will require member companies to disclose information on all clinical trials in patients. This new requirement will now extend to early-stage safety trials of medicines for life-threatening conditions. Member companies will still maintain discretion to disclose information from Phase I safety trials in health volunteers.

The Joint Position has already been approved by pharmaceutical associations from Japan, Europe and the United States respectively. Once the position comes into force, member companies will be responsible for posting details of new clinical trials in patients on a publicly accessible website within 21 days of the start of the patient enrolment. There will also be a requirement for member companies to publish summary result of the trials within one year of the relevant product being tested.

More detailed information can be accessed at the site below: http://www.ifpma.org/News/NewsReleaseDetail.aspx?nID=13083

U.S. FDA Contemplates New Rules for Internet-Delivered Health Information

By Melissa Binns

In recognition of the increasing use of the Internet by consumers for health-related information, the FDA is seeking to determine whether it needs to regulate the promotion of drugs and medical devices on the Internet. The FDA recently convened a two-day public hearing on November 12-13, 2009 called "Promotion of Food and Drug Administration-Regulated Medicinal Products Using the Internet and Social Media". Presenters included pharmaceutical companies such as Pfizer and Eli Lilly as well as Internet companies such as Google and Yahoo.

The Pharmaceutical Research and Manufactures of American urged the FDA to adopt a standard safety logo for Web content which would link FDA-approved information regarding a particular drug or device. Other options being considered to prevent misleading information include modified rules based on the FDA's current regulations governing more traditional sources of health information such as television and magazine advertisements.

An archived copy of the two-day public hearing is available online as set out below:

http://www.capitolconnection.net/capcon/fda/111209/FDAarchive.htm until December 18, 2009

Recent Cases

By Beverley Moore

Pfizer v. ratiopharm, Motion to Intervene in Appeal of Infringement proceedings; November 19, 2009, amlodipine

The Court of Appeal denied BIOTEC Canada's and Eli Lilly's leave to intervene in Pfizer's appeal of the Court's decision to invalidate a patent for amlodipine.

Our summary of the trial level decision of Justice Hughes can be found here:

The Court of Appeal held that a jurisprudential interest is not sufficient to grant intervenor status...