At the annual conference of the Regulatory Affairs Professionals Society (RAPS), held in Boston last week, the FDA’s Sandra Kweder (deputy director of the Office of New Drugs in CDER) gave a well-attended talk packed with sugary rhetoric.

Such statements could be taken as indicating that nothing will change in the agency’s stance toward the industry. But Kweder also used cayenne pepper in other remarks, hinting that there could be significant shifts in how the agency prefers to work with sponsors.

As we noted last week, Kweder discussed how the agency has studied its own process for reviewing new drugs. CDER will be testing this new, standardized version of its process throughout 2008.

For CDER staffers, Kweder said, the change will be significant. Some employees are nervous. “The transition from the way things work today to the new process is going to be the challenge,” she said. But from her perspective, as a longtime public servant who remembers the era before user fees, the shift will not be as radical. “This is less difficult,” said Kweder.

Balm For Your Wounds

First, the good news. There is no need for additional scrutiny of Phase I or certain types of therapeutic areas in the wake of the TeGenero trial in London, which threw the British news media into an anti-scientific, anti-industry lather. U.S. trial rules, she said, are appropriately stringent and unlikely to change. “We went back and looked at our regulations,” said Kweder. “We think we’re in a pretty good place where we are.”

As ClinPage noted in our earlier story, Kweder disagrees with the perception that the agency has become less likely to approve new drugs since the 2004 Vioxx withdrawal. She does not see a need for any sharp change in regulatory direction: “What I see is a public that recognizes the value of pharmaceuticals in health maintenance and health care, and the increasing dependence we have as a society on pharmaceuticals. This is the big stuff. We are not going to give up. We have to get this right.”

Kweder flashed a slide with a few unlabeled photographs. One face looked familiar. Kweder confessed a deep but unrequited love for the young Englishman, a fictional teenage wizard-in-training. Another snapshot, taken half a century ago, showed Kweder’s own parents at the beach. “My mom has breast cancer,” she told the audience. “My dad has prostate cancer. They’re in their 70s. When I was a medical student, they wouldn’t have survived.”

Salt For Your Wounds

Now for the hard part. Our interpretation of her remarks is that the agency may have some unwritten, as-yet unpublished hopes for how the industry will help it implement its new process.

By way of background, Kweder said the new FDA process has been well-received inside the agency, partly because some of its more productive teams already operate this way. Says Kweder: “When I ask them, how does it work, they love it. They love their jobs. There is a lot of discussion across review divisions. They feel that the process itself facilitates people contributing to the decision.”

Getting Organized

Why do the FDA worker bees like the new approach? Partly because “there are fewer problems in the wrap-up phase,” Kweder says.

To help with that, she gently emphasized planning on the part of industry. She suggested that industry tell the agency what it is planning well in advance. The information the industry has always supplied is welcome early in the process, she said. “We have to shift that back, and not only to the beginning of the application, but to pre-application planning,” said Kweder.

The FDA is front-loading its own intellectual work as well. She said the FDA might be considering the drug’s label much earlier in the process than it typically does, not simply to make sure that the FDA hits the ambitious timelines prescribed by federal legislation.

Emphasis on Completeness

The recently approved federal legislation for user fees, she said, should result in additional financial resources. Those are welcome. At the same time, some of the 300 new staffers are going to be green. “We don’t control our own hiring. It’s a departmental thing,” said Kweder. “We have lost that battle.”

Another theme: completeness. Kweder joked about the number of submissions that arrive in the last week of December every year: “Guess what percent are complete? Not many.” She said the agency’s new process will be tuned to work best with complete dossiers, not partial ones. “What we need from you is a complete application. I don’t care if we went to college together. We still need complete applications at the time of submission.”

Watching The Clock

Kweder says the agency’s expanding head count would allow each CDER division to soon have both an associate director for safety and a regulatory project manager for safety. Says Kweder: “These are both full time jobs. The volume of the work, the breadth of the issues is staggering.” It sounds like the agency is planning a broader, more careful system for tracking drug safety issues. “We never had a good system for tracking post marketing safety issues. It was always a list on their desk or in their PC.”

Kweder doesn’t seem to think that technology or digital submissions will change much. “Some of us like some paper,” she said. But the eCTD handwriting is on the digital wall. “We are moving toward all electronic. We aren’t there with total consistency yet,” she added.

Kweder did say there is talk of an entirely new type of “technical” pre-review meeting in which a sponsor demonstrates any novel aspects to an electronic submission. “We do have some standards, but within the standards there is a lot of room for uniqueness. One of the things that facilitates a quick review is not having to spend a month on what button does what.”

Hard Label Timelines

In one of her most stark comments, Kweder suggested that negotiations between sponsors and the agency would be governed by a more strict timetable. (It’s not clear to this correspondent if that timetable is yet to be written, or is buried in the 400-page law.)

Speaking of the new user fee legislation, Kweder said: “It specifies timelines for labeling changes. You and we will not be able to spend six, nine months over safety labeling change. It won’t be allowed to happen. There are timelines for you and timelines for us on when we have to cut to the chase. After a certain amount of time, we can say enough, this is the label.”

It may just have been our perception, but Kweder sounded relieved at the ability to wind up what have become fairly familiar and protracted label discussions with industry.

Editor’s note: This is our first story on what Kweder said at RAPS.

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