On August 11, 2020, the United States Food and Drug Administration (FDA) held a public meeting to discuss a report that reviewed the agency’s communication with industry. The review found that overall, communication was timely, collaborative, and effective at moving development programs along.
The report gathered data from the FDA and included an industry poll outlined the number of communications and the timeliness of the communication from FDA at each state in the drug development process. While the report found that investigational new drug (IND) application-related communications were largely found to be “clear, effective, efficient, collaborative, and timely,” staff shortages and heavy agency workloads did present challenges. The report also noted that pre-COVID-19, teleconferencing was usually marred by technical glitches and challenges.
Breakthrough Therapies Had Higher Rates of Meetings Per IND
Over the one-year assessment period covered by the report (July 31, 2018 through July 31, 2019), sponsors requested a mean of 1.7 meetings per IND application. However, for breakthrough drugs, that figure was 2.7 meetings per IND application. Of these, sponsors requested meeting dates that fell within FDA guidance just 57% of the time. Additionally, only 54% of the requests contained all required items and 29% contained all the guidance-recommended items. In 90% of studied cases FDA staff who were knowledgeable in the relevant subject matter areas answered the questions submitted by sponsors.
FDA granted almost all requested meetings and FDA responded to meeting requests within the guidance-recommended timeframe 82% of the time. There were occasions where the question and path for development was very clear, and in those instances, a written response only would suffice.
Most Package Submissions Were Incomplete
As alluded to above, receiving complete applications was sometimes difficult. Of all submissions, 79% were submitted on time, with just over a third (35%) containing all the items FDA recommended in the pertinent guidance.
FDA issued a mean of 1 preliminary comment per IND (2.5 for breakthrough drugs), with 84% of these responses happening in a timely way. Meetings were cancelled by the sponsor 22% of the time after they received FDA preliminary comments, which meant that the questions were adequately answered without needing a meeting in these cases. About a third of the time, FDA responded by saying that the meeting package submission did not contain enough information for the agency to answer at least one of the questions posed by the sponsor.
Post-Meeting Responses
89% of post-meeting minutes or written responses only were sent out within the guidance-recommended time frame and the content of the responses was consistent with the meeting discussions. More than half of the minutes or written responses also addressed topics not included in meeting packages. For each IND, FDA sent a mean 4.4 information requests to sponsors, and sponsors submitted a mean 14.3 amendments to FDA.
Industry Feedback
Industry feedback in the meeting also identified some notable gaps in communication.
Eric Larson, senior manager for regulatory affairs in the global regulatory strategy department, affirmed that accurate, clear and timely communication from regulators is key to advancing products through the IND process. “My own experience, and that of most of my colleagues, has been extremely positive working with regulatory project managers.” Larson did note, though, that the differences in communication practices between [FDA] divisions can be “striking,” with differences ranging from allowing slide presentations during meetings to preferences for postal service communications or email exchanges.
Cartier Esham, PhD, senior vice president of science and regulatory and executive vice president of emerging companies at the Biotechnology Innovation Organization (BIO), also shared industry perspective. “We would like to work together to establish a mechanism for sponsors to obtain questions to clarifying questions following milestone meetings,” said Esham. By working together in such a way, additional meetings may be avoided as could consequent delays in development. Esham also suggested that instead of limiting the number and scope of sponsor questions for a meeting, industry and FDA should work together “to ensure meetings accomplish their purpose.”