In March 2019 Health Canada announced that it would start making clinical information about the safety and efficacy of drugs and medical devices available to the public after a regulatory decision is made. The agency says that making the data available will allow for independent analysis increasing patient safety. The data released is data that was formerly treated as confidential by the agency and is still treated as confidential by the U.S. Food and Drug Administration (FDA). It is not a new concept. The European Union has had a similar program since 2016. It is time for the FDA to catch up and follow suit with this important move for public safety.
If Other Countries Release the Information, Why is it Needed Here?
You may be wondering why it matter if the FDA makes the information public when other agencies already do so. The FDA often approves drugs and devices before they are approved elsewhere and some are never approved in other countries, meaning the data remains hidden from independent researchers who may find risks that are not revealed in articles written about the studies in medical journals.
Articles about clinical trials are not always accurate. They often emphasize the benefits and downplay the risks or drawbacks. A large portion of clinical trials are not covered in medical journals at all. Researchers and medical societies need the raw data in order to truly evaluate new drugs and devices and provide guidance on their best use.
To learn more about your rights after being harmed by a defective drug or medical device, contact an experienced defective attorney and schedule your free consultation.