Background
In 2018, the Food and Drug Administration (FDA) launched a pilot to test the capability of publicly posting summaries of the safety and efficacy information that is used to make drug approval decisions. This followed suit with the European Medicine Agency’s (EMA) Policy 0070 that launched in 2015 and Health Canada’s (HC) Clinical Information Portal that launched earlier this year. Portions of the module 5 clinical study reports and the module 2 summaries from the drug company’s new drug application would be posted to a FDA website following drug approval. At the launch of the pilot, nine drug companies with recently submitted new drug applications were approached to volunteer to participate. On June 26, the FDA announced that the pilot phase has now concluded, with only one company agreeing to participate and have their reports posted.
Notice Seeking Feedback
The FDA has now published a federal register notice seeking feedback on the pilot with all comments due by August 26, 2019. If the FDA moves forward with the program, drug companies will have three major regulations to contend with for clinical trial disclosure (i.e., EMA Policy 0070 and HC), with potentially more on the way. The Ministry of Health (MOH) of Ukraine is also asking for public comments to their draft order to publish results of preclinical studies and clinical trials for all drugs registered in Ukraine within 5 years from the date the order comes into force. The full scope of that regulation remains to be seen, however the MOH has a timeframe of becoming official by the end of 2019.
Future Impact
Here in the United States, many questions remain. Will the FDA decide to accept certified submissions from the other two regulatory authorities? HC currently accepts submissions that are already posted to the EMA clinical data portal. Since the EMA temporarily suspended work on Policy 0070 in 2018 due to Brexit and the relocation of its headquarters, we are also still waiting to see if the EMA will allow HC submissions to be certified for Policy 0070 publication in return. Our Synchrogenix transparency and disclosure experts are keeping a close eye on the future impact of all global regulatory guidelines.
Additional information: FDA-in-Brief