Full article reprinted from "The Gray Sheet" - April 27, 2009
FDA officials that regulate lab tests don't think they have been active enough in the policy debate over the future of personalized medicine; but, they say, that is about to change.
FDA Diagnostics Office Seeks Bigger Role In Personalized Medicine
Full article reprinted from "The Gray Sheet" - April 27, 2009
With additional funding and attention from the highest levels of FDA, the Office of In Vitro Diagnostic Device Evaluation and Safety will play a larger role in discussions about regulating and encouraging more individualized therapeutic strategies, according to Don St. Pierre, acting director of OIVD.
OIVD received funding this year for an additional 10 full-time equivalents to focus exclusively on personalized medicine as part of broader hiring efforts in the office (see sidebar: "1OIVD In Transition"). The office plans to tap existing FDA staffers for the new posts and backfill their spots with the allotted new hires.
"We've been involved with personalized medicine since people started talking about it, but we weren't staffed up or geared towards trying to make that a priority," St. Pierre said in an interview. "A lot of this was being driven by the center for drugs."
OIVD is still figuring out how to organize the personalized medicine group, but it is clear its work will cut across all divisions of the office. And perhaps more importantly, the dedicated staff will make it easier for the office to focus more time on cross-FDA personalized medicine initiatives, St. Pierre suggests.
The office, for instance, was not able to participate significantly in the development of the 2005 drug center 2guidance on voluntarily submitting pharmacogenomics data as part of FDA drug applications or in previous FDA-National Institutes of Health personalized medicine policy interactions.
With the additional staff, "We'll be able to play more of a role in those discussions, we'll have more of an influence [and] we'll be able to drive some things more than we've done in the past," St. Pierre said.
OIVD Has Well-Connected FDA Friends
In addition to the better staffing, the diagnostics office also appears to be gaining more leverage across FDA in other ways.
OIVD staffer Liz Mansfield recently moved to FDA's head office, where she is senior genomics advisor in the Office of Chief Scientist, a newly created position. Mansfield is on detail from OIVD and continues to work closely with her former colleagues (3"The Gray Sheet" Feb. 23, 2009, p. 19).
"It's actually very nice having someone up there who understands what we do, so that that can be factored into the cross-cutting genomics efforts that are going on across CDER, CBER and CDRH," St. Pierre said.
And former OIVD reviewer Francis Kalush is now heading up the "diagnostics and personalized medicine" matrix network, one of 13 groups established by CDRH in 2008 to facilitate cross-center interaction on different device and medical topics (4"The Gray Sheet" July 21, 2008, p. 7).
Kalush's network is one of the few that has an explicit mandate to collaborate with the drug and biologic centers on various policy issues, in particular, establishing a regulatory framework for combining drugs and diagnostics for personalized medicine treatment strategies.
Co-Development Process Is A Core FDA Challenge
Drug-diagnostic co-development is in fact one of FDA's core challenges in personalized medicine.
It is one thing for OIVD to come up with a guidance on pre-market submissions for pharmacogenetic and genetic tests, as it did in 2007 (5"The Gray Sheet" June 5, 2007, p. 9), and for the drug center to develop a route for pharmaceutical firms to submit pharmacogenomic data, as it did with the 2005 guidance.
But putting everything together in a process that allows some sort of tandem approval is a bigger challenge. It involves coordinating the different regulations, development timelines and business models associated with drugs and assays.
And while there are some instances when a single company, like Roche, may be working on an entire co-development project in-house, multiple companies will often be involved (6"The Gray Sheet" Feb. 23, 2009, p. 21).
"Really integrating all of those things together is challenging," affirmed Courtney Harper, acting director of OIVD's Division of Chemistry and Toxicology Devices, April 21 at the Association of Medical Diagnostics Manufacturers' annual 510(k) workshop in Rockville, Md. "We are trying to come up with more guidance."
FDA put out a co-development "concept paper" in 2005, to which OIVD contributed. But the document was met with complaints from industry that FDA was attempting to restrain drug and diagnostic development into unrealistically parallel processes (7"The Gray Sheet" July 31, 2006, p. 9).
The agency had hoped to follow up the paper with formal draft guidance, but that has proven difficult; agency officials warn not to expect draft co-development guidelines anytime soon.
Nonetheless, increased involvement by OIVD in the agency-wide effort should be very helpful because, in essence, personalized medicine is "all that OIVD does," Harper said, pointing out that all lab tests are used to drive medical treatment in some way.
"We realize that all of us in the IVD field have been doing personalized medicine for years," she said. "Now we are going to advertise it."
- Jessica Bylander and David Filmore
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