A recent survey of the biopharmaceutical industry conducted by GartnerG2 indicates that the FDA could do a much better job of communicating the specific steps necessary to become compliant with the 21 CFR Part 11 regulation for electronic records submitted as part of drug applications.
The survey’s preliminary findings “reinforce the need for clear guidance from the FDA,” Gartner healthcare analyst Jonathan Edwards told BioInform. “There’s a lot of confusion about the regulation.”
The survey, conducted in May and June, included feedback from 86 life science firms — small, medium, and large pharmaceutical and biotech companies as well as contract research organizations and medical device manufacturers. The bulk of respondents — 76 percent — described themselves as “currently engaged in Part 11 compliance,” while the remainder were split fairly evenly between those who were “already fully compliant for all systems” (7 percent), those who “plan to be engaged in the next 12 months” (10 percent), and those who “plan to be engaged in the next 13-24 months” (7 percent). Only one percent of the survey participants said they had not yet taken any action toward making their systems compliant.
The survey indicated without a doubt that “Part 11 is an IT problem,” said Gartner analyst Dan Miklovic during a teleconference to discuss the survey results on July 8. The internal IT departments of 44 percent of responding companies are involved in the compliance process, while only 32 percent of firms indicated that an internal compliance department was handling the job. But companies aren’t relying solely on internal resources — 44 percent of the companies who responded said they have turned to software vendors for at least part of the process (see chart). Part 11 compliance is expected to lead to increased IT spending at 60 percent of companies, and 45 percent of those expect the increase to be in the 1-24 percent range (see chart). One concern, according to Miklovic, is that “there are some small, $100 million and under companies who believe that Part 11 compliance can cost them as much as $500,000 a year on an ongoing basis. That represents a significant amount of their revenue.”
As far as the overall costs of compliance, “41 percent of billion-dollar companies had no clue as to how much Part 11 compliance was going to cost them going forward,” said Miklovic. “That number is quite scary in the sense that it represented a large percentage of the population.”
Only 41 percent of respondents included “faster approval of submissions” among the anticipated benefits of Part 11 compliance, while 93 percent listed “better data security” among the expected perks. Not surprisingly, “bringing legacy systems into compliance” topped respondents’ lists for the greatest challenge in compliance, with 40 percent ranking that as their biggest hurdle, closely followed by “interpreting the regulation,” listed by 19 percent.
But interpreting the regulation may actually be a bigger challenge than that response indicates. While 59 percent of respondents said they use the FDA website most often for information on compliance, only 8 percent said they rely more on direct contact with the FDA. “We found that a little bit disturbing,” said Edwards, “because we’ve heard from many of the organizations that we’ve spoken to that [they] are finding the FDA website not particularly clear and focused in terms of providing information on how to comply with the regulation.”
Compounding the industry’s confusion about the details of compliance is the fact that the FDA withdrew its draft guidance in February as the first step in a plan to re-examine provisions of the regulation [BioInform 03-03-03]. The agency intends to narrow the scope of CFR Part 11, but until the final guidance is released, the industry harbors a number of doubts about its enforcement. “With the shift in guidance, it’s unclear as to what the enforcement status will be,” said Miklovic. “There had been some enforcement efforts prior to February, but they’ve backed off of those now…and are reformulating the enforcement policy.” Around 9 percent of the responding firms said they were uncertain when they would achieve full compliance due to the FDA’s announcement.
According to Gartner analyst Carol Rozwell, written responses from participants indicated “that they would like the FDA to be specific, and to better define the regulation itself. Also, there was a call to make sure that the guidance was developed quickly.” Other responses indicated that industry is looking for the FDA to begin enforcing the regulation, Edwards said, “because then it will help [them] figure out where [they] need to make improvements.”
Source: GartnerG2. Due to rounding, percentages in pie charts do not add up to 100%.