By Lisa Seachrist

Washington Editor

WASHINGTON - The FDA's Center for Biologics Evaluation and Research (CBER) has informed biotech and pharmaceutical companies it will defer activities on all biologics license applications (BLAs), product license applications (PLAs) and establishment license applications (ELAs) from June 26 to July 20 while it installs its database and tracking system.

The agency announced the undertaking and subsequent deferment in the June 22 Federal Register and in letters to companies. During the deferment, the agency is requesting that applicants voluntarily refrain from submitting BLAs, PLAs and ELAs as the agency will be unable to start or continue work on these submissions.

"It was very clear nobody was going to be very happy about the situation," said Robert Yetter, associate director for review management at CBER. "I put out the notice as soon as I knew when this was going to happen. If I could have given people more lead time, I would have."

During the deferment, CBER will put in place a new database system designed to handle the needs of the agency post-Food and Drug Modernization Act (FDAMA). The current database and tracking system can't easily keep up with the reporting requirements encompassed in FDAMA, Yetter said. In addition, the current system is old technology that isn't easily tweaked to address the agency's current and expected needs.

"The [current system] is designed to track PLAs and ELAs, which will no longer exist as of October," Yetter told BioWorld Today. "Because this system is so pervasive, we can't simply switch to the new system. We are telling people this might take as long as a month. We believe and hope it will take less time than that. We think the glitches will be minimal, but until you actually push the button, you won't know."

Moving to the new system is more complicated than simply upgrading a few computers. Yetter said the process will require all of the data in the current system be moved to the new system. After that point the data must be validated and the new system validated before CBER can get back to regular business.

"Our technical people tell me migrating the data from one system to the other will take at the very least a few days," Yetter said. "Unfortunately, we will need to have the people who ordinarily process these filings validating the data. I know companies would like us to be able to function while we are setting this system up, but we are far beyond the time when we could take care of the things with pencils and 3-by-5 note cards."

During the deferment, or hiatus, as some have referred to it, any submissions mailed to the agency will be held until the new system is in place. The agency plans to address submissions in the order in which they arrive. All review of pending submissions will be suspended during the database conversion period and due dates for those submissions will be extended by the length of the actual deferment.

In response to the news of the deferment, Biotechnology Industry Organization (BIO) President Carl Feldbaum wrote a letter to CBER Director Kathryn Zoon.

"I expressed some deep concern about this plan," Feldbaum said. "The smaller [BIO] members are very upset. I'm not sure I've seen a month-long time-out for a critical federal agency in all my years in Washington."

Companies can keep abreast of CBER's status and progress at CBER's home page at http://www.fda.gov/cber/genadmin.htm.

"There really was no way to do this with no impact," Yetter said. "But, once it's completed, it will allow us to fulfill our regulatory responsibilities more readily."

House Committee Sends Medicare Provision To Floor

In a straight party-line vote late Wednesday night, House Republicans on the Ways and Means Committee passed the GOP's plan for providing prescription drug coverage to Medicare recipients.

The bill, which was rendered into legislative language just one week ago, now moves for a vote by the full House. House Speaker Dennis Hastert (R-Ill.) has said he intends to have the bill passed before Congress breaks for its extended July 4th holiday next Friday.

"[House leadership] said this would be their schedule; few people really believed them," Feldbaum said. "This is a very fast train right now."

Feldbaum said the bill passes two of BIO's key tests by relying on the private sector and providing stop-loss coverage for catastrophic drug costs. However, BIO isn't endorsing any plan at this time.

"A matter of this gravity ought to be very well considered," Feldbaum said. "We've been able to stay on top of it, but this is a very delicate issue."

In the aftermath of the vote, the White House expressed its dismay over the movement of a "deeply flawed prescription drug benefit."

"Last night, the House Ways and Means Committee, on a straight party-line vote, passed out a private insurance drug benefit that the insurance industry itself has consistently stated won't work," a White House statement from the president's press secretary said. "They voted against every Democratic amendment designed to strengthen the benefit and ensure that all Medicare beneficiaries would have access to an affordable prescription drug benefit. When the Republicans had the opportunity to support a true Medicare benefit that would be available to all beneficiaries, each and every one of them voted against it."