Info & Opinion
April 23, 2014
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
The Food and Drug Administration Amendment Act of 2007 (FDAAA) is vast. And overwhelming. At least one FDA official seems daunted by it, nine months after it became law.
Take Sandra Kweder, deputy director of the FDA’s Office of New Drugs. Last month, at the 2008 Drug Information Association (DIA) conference session on how FDAAA will impact drug safety, she signaled that the agency is straining to deliver what Congress wants.
“The authorities, and responsibilities and task requirements of FDAAA are absolutely mind boggling,” Kweder said. “Our progress overall can be summarized by saying: Well, we have a lot of the same questions that you do. The legislation is extraordinarily complicated. d9A2t49mkex The documentation is profound. Then there’s the workload. We’re all asking: who will do this work? Who will do this work?”
Kweder reviewed slides outlining the FDA’s progress on implementing key parts of the act.
Risk Evaluation and Mitigation Strategies (REMS): An update to the FDA’s former RiskMAP, a REMS allows the FDA to require additional risk mitigation strategies, such as requiring a pharmacist to show the patient a video before she can dispense a particular drug. REMS will affect new product approvals as well as those currently on the market.
Though Kweder says she’s seeing new drug submissions get delayed due to companies’ confusion about REMS, she admits that the agency isn’t far along on what to do about REMS. “We are starting to look at these risk and benefits balances and what would be required a little bit more critically,” Kweder said. But, she added, “I think it will be a while before we have clear standards that we can articulate about the next step beyond RiskMAPS.”
Pediatrics: “We are fully on track,” said Kweder of FDAAA’s Pediatric Research Equity Act (PREA), which gives the FDA authority to require pediatric studies of drugs to ensure they are safe for children. “I think this is one of the most important pieces of safety activity in the entire act,” Kweder said, adding that the FDA now has an internal review committee that is required “to touch any and every pediatric decision that goes through CDER (the Center for Drug Evaluation and Research). We have never had any kind of oversight activity internally that requires this level of effort.”
One area that still troubles Kweder, though, is the tracking requirements inherent in PREA. “If you look at the list—the laundry list of things we’re supposed to keep track of and keep tallies of—it’s overwhelming, absolutely overwhelming and that’s something we’re continuing to struggle with,” she said.
Labeling requirements: Under the new rules, FDA can order drug companies to list all new safety recommendations on drug labels. This is especially helpful in class labeling, as it will decrease the back-and-forth with individual firms, a process that delays labeling, said Kweder.
Post-marketing studies: The FDA is “steady, on track,” reported Kweder. With FDAAA, the agency can ask drug companies to conduct further clinical studies after a drug is on the market.
“We are still learning what is required versus agreed,” said Kweder. “This is really forcing all of us to sit down and think hard about what is essential. FDA reviewers are not out there doing the studies. They don’t know what a realistic goal for recruitment is over time. And we have to learn that.”
Postmarketing surveillance: “We are just getting started,” said Kweder. “I think this is going to be one of our greatest challenges.” The agency’s task under this legislation is to obtain access to and find ways to bridge very disparate data sources, some of them coming from the government, some of them coming from the private sector, Kweder explained.
“And then of course there’s the big question: with what information technology resources are we going to do this and how?” Kweder said. “It has to be a collaborative effort and we must rely on partnerships with industry, with the nonprofit sector, with the private sector and academia to get this done.”
Can the FDA do it all? Yes, if it can get the staff in place, said Kweder. “FDAAA came with a lot of money but…in terms of progress, it’s a jungle out there. Our staff was stretched beyond capacity before this legislation was passed. And when you add this Goliath to the mix and we really just have the same people sitting in offices, it’s pretty daunting. Money doesn’t immediately translate into capacity.”
Kweder added that the FDA is now looking to hire an additional 1,300 people.
It’s all going to take time. Perhaps a lot of time. To put it into perspective, Kweder said the FDA is still trying to implement parts of the Food and Drug Administration Modernization Act (FDAMA), which passed 11 years ago.
“This is a big ship that’s trying to turn, and it turns very slowly,” she said. But “Congress and the public expect a more prominent FDA in the health care system. We stand ready to be part of that. We’ll be deliberate and we will be judicious, but we’ll be pragmatic, and at the end of the day, public health will rule.”
—by Suz Redfearn