Regulatory Focus™ > News Articles > Health Canada to Release Drug, Device Rejection Letters

Health Canada to Release Drug, Device Rejection Letters

Posted 23 March 2016 | By Zachary Brennan 

Health Canada to Release Drug, Device Rejection Letters

As drug and device manufacturers are still not obligated and often don’t fully explain why their products were rejected by the US Food and Drug Administration (FDA), Health Canada has moved ahead to release its rejection reports beginning 1 May.

The move by Health Canada, which will apply to any decisions issued after 1 April 2015, will mean the release of all final negative decisions and withdrawals for all new drug submissions (NDSs), supplemental new drug submissions (SNDSs) for new indications and new Class IV medical device applications.

Health Canada will also release new information publicly when new drug and device applications are submitted, which FDA also does not currently release.

"FDA is considering the full range of policy options on the release of complete response letters; however, it would likely require a change in FDA’s regulations," agency spokesman Stephen King told Focus.


Health Canada’s push to make more information public comes as part of a larger transparency shift by the regulator that also seeks to release more data on new safety reports and advertising complaints.

The European Medicines Agency (EMA), meanwhile, for almost a decade has published what are known as European Public Assessment Reports (EPARs), which include public information on each medicine after the European Commission has issued a decision regarding the application. Negative opinions and withdrawn applications are published.

In contrast, in the US, companies continue to withhold information from the FDA rejection letters and don't offer details on the full picture of why a drug was denied approval because of the potential release of proprietary information in the complete response letters (CRLs), according to a British Medical Journalstudy from last summer.

Of 61 CRLs issued between 2008 and 2013, FDA officials found that no press release was issued for 18% (11) of those reviewed, and 21% (13) of press releases did not match any statements from the letters.

“FDA generally issued complete response letters to sponsors for multiple substantive reasons, most commonly related to safety and/or efficacy deficiencies,” authors from FDA wrote. “In many cases, press releases were not issued in response to those letters and, when they were, omitted most of the statements in the complete response letters. Press releases are incomplete substitutes for the detailed information contained in complete response letters.”

FDA crafted a proposal in 2010 to begin publicizing the CRLs, releasing information on when new applications were submitted to the agency and even making an effort to protect companies’ trade secrets, but the effort never evolved past a proposal.

“In general, industry comments [on the proposal] stated that the protections set forth in current law represent the correct balance between disclosure of information and maintaining the confidentiality necessary to foster innovation,” FDA said at the time. “Comments from manufacturers and industry trade groups contended that early release of information about the status of, or safety and effectiveness information on, products in development could give competitors an advantage by providing access to previously unavailable insights into the development process and harm incentives for innovation.”

Since the proposal didn't muster enough support to move forward, FDA has cobbled together a new transparency site, known as FDA-TRACK, which tracks stats and other performance data. But as Health Canada begins to disclose more information like its EU counterparts, and the release of rejection letters and application filings becomes the norm rather than the exception, perhaps FDA will follow suit.

Health Canada Notice: Regulatory Decision Summaries and the Submissions Under Review List


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