The recent Drug Information Association (DIA) conference on data management had the usual number of FDA presentations that put many commercial conferences to shame. And one of the most interesting FDA presentations was from Armando Oliva, deputy director of bioinformatics in the office of Critical Path programs. That’s inside the Commissioner’s office.

After the usual disclaimer that his views were not the FDA’s, but his own, Oliva launched into a wide-ranging discussion of the agency’s efforts to encourage industry to use more electronic data.

Oliva noted that the transition to electronic data at the agency has been gradual. “It still amazes me that here we are. We have been receiving electronic data as long as I can remember, but it is still not required. That seems like the next logical step.”

It’s not clear to us whether FDA would have the authority to make that decision on its own, or whether Congress would have to step in. If our current roster of politicians have to agree on it, naturally, it’s a safe bet it won’t happen soon.

eCTD Push

The agency has already stipulated that older electronic formats for submission data are being phased out this year, and the eCTD is being required for electronic submissions in 2008. (Paper documents, however, are still allowed). There will be some extensions and waivers, Oliva predicted, but that is not an inducement to procrastinate. “The last thing we want to see is a rise in paper submissions because people can’t post an eCTD by next year. The eCTD is more efficient. It is the superior technology.”

Oliva noted that the agency held a so-called “Part 15” meeting in December 2006 soliciting early public input on the topic of sharing clinical research data. The NIH also attended. Oliva said he was encouraged by the comments at the session. “The question was not whether we should go to all electronic, but when do we do that and how do we get there?”

Oliva continued: “For study data not a whole lot changes. We still accept SAS transport files. SDTM is preferred but not required,” he said.

Targeting Silos

At the end of his talk, Oliva conceded what everyone in the room already knew: that the FDA is actually comprised of a variety of mini-regulatory fiefdoms for drugs, biologics, devices, veterinary medicines and other subcategories.

“FDA for decades was these silos working almost without talking to each other,” Oliva said. “That’s changing, very notably. I can’t promise you will see harmonization this year or next year. But there is renewed interest.”  He cited the Electronic Submission Gateway as an example of a tool that the entire industry, not each niche, can use to send 100 gigabyte filings to the agency.

Within the agency, he said, “there is a high degree of interest and energy to look at business processes and review our processes and understand what they are. If there is no good reason for them to be different, let’s look at that.”