Canada Now Discloses Clinical Data for Approved/Rejected Drugs, Possibly Pressuring FDA for more Disclosure

Canada’s department of health is taking a radical departure from the U.S. Food and Drug Administration (FDA) by making large chunks of drug and device application data publicly available online via an information portal.

NPR’s Barbara Mantel recently discussed this significant Canadian commitment to new drug transparency in clinical research showcasing how by making the information public it offers the public an understanding of the rational regulators made to approve (or reject) a new drug application, for example.

The Information Portal

Within 120 days of a decision, Health Canada posts clinical study reports on the new government online portal, first uploading drugs that contain novel ingredients and then adding devices and other drugs over a four-year phase in period reports NPR.

The portal includes considerable amounts of data of the new drug reports that can run more than 1,000 pages. The portal includes valuable information about each drug including manufacturer, ingredients, key dates, etc.

Stark Contract to FDA

TrialSite News recently completed a research project where we sought to identify for every approved drug in 2019 and 2018 exactly when the approved drugs’ Investigational New Drug (IND) filing occurred. This information would help us identify exactly how long it took to get the drug from first clinical trial through all phases and to new drug application or NDA. This information was extremely difficult to obtain and in many cases not possible to secure. In fact, we reported that one of our researchers received a message from the FDA that IND information was proprietary data of the drug manufacturer and that we would need to obtain their consent to share with us directly. This seemed very strange.

FDA Position: U.S. Laws don’t Offer the Same Flexibility to Share? Is this True?

NPR reported that when questioned about the Canadian changes, Sandy Walsh, a FDA spokesperson, declared that they (FDA) doesn’t have the same freedom as Canadian and European regulators to release clinical study reports. She noted in an email to NPR that “U.S. laws on disclosure of trade secret, confidential commercial information, and personal privacy information differ from those governing EMA and Health Canada’s disclosure of clinical study reports.”

However, Amy Kapczynski of Yale law and co-director of the university’s Collaboration for Research Integrity and Transparency, noted FDA has more flexibility that it acknowledges as federal agencies are “entitled to substantial deference” in determining “what constitutes confidential commercial information” as noted in The Journal of Law, Medicine & Ethics.

Progress

Barbara Mantel of NPR reports that thus far Health Canada has posted four new approved drug reports (One for plaque psoriasis in adults; two to treat two different types of skin cancer, and the fourth for advanced hormone-related breast cancer). They are planning on releasing reports for another 13 drugs and three medical devices approved or rejected since March. Their move follows a similar policy enacted in Europe.

More Transparency is a Good Thing

In the U.S., as we move to a value-based health system, among other things it requires educated and empowered consumers to better understand how to take control of their health care; make better decisions and contribute to a turnaround for what we at TrialSite News believes is an ominous, far reaching healthcare crisis. Transparency in health markets represents a fundamental value proposition that cannot be ignored.  Drug industry claims that disclosure of study data would discourage biomedical research is ludicrous. Already disclosure rules in Canada and Europe are in place and drug companies won’t flee from research in those regions of the world. After all, much of what is proprietary in a drug is captured in its patent which is available to the public once filed as just once example

In the United States, people should have the ability to easily access clinical study reports. To become more educated and empowered consumers, we need to have transparency—access not just to drug or device information but also to other critical health-related information such as provider prices by category, classification and region– which is very difficult to obtain. Value-based health models necessitate educated and empowered healthcare consumers.