H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

More documents

Recommendations

Info

NBSB Pandemic Influenza Working Group Detailed Report complex diagnostic and treatment landscape. (In additional, seasonal influenza may be resistant to oseltamivir.) Antiviral resistance testing and serology are not easy to get. Dr. Jernigan listed the following areas for focus for the CDC: Maintain IRR and support for PCR testing at qualified U.S. laboratories and international laboratories. Enhance virologic surveillance in Southern Hemisphere and Tropics to monitor genetic, antigenic, and susceptibility changes. Improve surge capacity. Facilitate development and field evaluation of tests for improving clinician access to pandemic H1N1 diagnostics. Collaborate with partners to revise clinician testing guidance. FDA Perspective: Diagnostics for Influenza Pandemics—Sally Hojvat, Ph.D., FDA Dr. Hojvat described FDA’s mission and goals for pandemic influenza preparedness. She said the streamlined effort to get new diagnostics out to public health labs illustrated the benefits of collaborations with CDC and NIH over the years. To facilitate product development that would address pandemic needs, FDA is active with commercial entities in trying to move forward with diagnostic tests useful to public health labs and in encouraging those who already have testing platforms in labs to work on an H1N1. FDA seeks to anticipate potential shortages. Dr. Hojvat pointed out that when the H1N1 outbreak occurred, rapid tests were in short supply and FDA worked with U.S. port authorities to get large quantities from overseas producers shipped as quickly as possible. FDA ensures product safety and efficacy by making sure that performance is established in a consistent manner, but validation of the many available tests remains an open question. FDA does not monitor manufacturing processes until products are cleared. Some cleared diagnostic tests have poor performance but good manufacturing processes (GMP). FDA does monitor adverse events (AEs) for cleared products. Dr. Hojvat described the various pathways to clearance for an in vitro diagnostic device for influenza. Because it would be a Class-I device, manufacturers would not have to conduct a huge clinical trial but would have to demonstrate the product is safe, effective, and substantially equivalent to existing devices. Unfortunately, sensitivity has never been very good with rapid tests, so the bar for demonstrating equivalence is low. Dr. Hojvat said FDA is using its RNA test to try to set a baseline of about 90% sensitivity for rapid tests. For H1N1, FDA has been using EUA as a pathway to clearance. Dr. Hojvat described the use of EUA, emphasizing that it is not a substitute for approval, license, or clearance. It requires no informed consent and no IRB approval, and manufacturers don’t have to demonstrate GMP or register the product. Every EUA requires that the HHS Secretary has declared an emergency; after that, FDA will consider 58
NBSB Pandemic Influenza Working Group Detailed Report each product on a case-by-case basis and may establish conditions to restrict use of the product. FDA consults with NIH and CDC before approval of an EUA. Dr. Hojvat summarized the four statutory criteria for consideration of an EUA. A request for an EUA can come from any source, and FDA encourages submitting data for pre-EUA consideration when feasible. With data in hand, FDA would be able to move more quickly once an emergency is declared. The EUA expires when the emergency ends, and the product can no longer be used unless it’s licensed. FDA encourages manufacturers and other applicants to be prepared to apply for licensure or consider a parallel clearance process for its EUA submission. Requests for EUAs are prioritized on the basis of several factors, such as the following: Seriousness of the clinical condition Incidence of the clinical condition Effect use of the product may have on ensuring national security Availability of product in government stockpiles Feasibility of use of product in a large population Request of another government agency Availability of a similar product Adequacy of supporting non-clinical and clinical information Quantity of product available Dr. Hojvat described the information that FDA requests for an EUA; she stressed that if a test has been validated in a lab, all of the requested information should be available. FDA has approved only two EUAs for H1N1 to date: the CDC PCR kits and the fivetarget panel. It is currently reviewing about six formal requests and multiple unofficial inquiries, all involving nucleic acid-based diagnostics. None of the requests include true POC rapid diagnostic devices. For EUA denials, FDA is working with the submitting party on products that might be useful in the fall and cleared either through an EUA or the 510k clearance process. EUA approval requires input from NIH and CDC. FDA’s short- and long-term strategy for diagnostics involves the following: Continuing to work closely with CDC, NIH, and HHS on preparation/testing needs strategy for upcoming influenza season. Making information required for EUA authorization widely available and establishing a standard template for validation of all H1N1 diagnostics. Rapidly granting EUA authorization for diagnostics that support public health needs. Prioritizing review of existing/new diagnostics if virus reassortment occurs. Encouraging submission of 510(k)s as H1N1 becomes a “seasonal H1N1.” 59
Page 1 and 2:
H1N1 COUNTERMEASURES STRATEGY AND D
Page 3 and 4:
NBSB PIWG H1N1 Countermeasures Stra
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
NBSB Pandemic Influenza Working Gro
Page 15 and 16:
Page 17 and 18:
Page 19 and 20: NBSB Pandemic Influenza Working Gro
Page 69: NBSB Pandemic Influenza Working Gro
show all

H1N1 COUNTERMEASURES STRATEGY AND ... - PHE Home

Create successful ePaper yourself

Delete template?

Save as template?