"Acknowledging that the development of medical countermeasures against bioterrorism threats and pandemic flu is lagging, [U.S.] federal authorities Thursday announced a $1.9 billion makeover of the system for identifying and manufacturing drugs and vaccines for public-health emergencies," Tribune Company/Seattle Times reports. "The overhaul includes manufacturing refinements aimed at shaving weeks off the time it takes to produce pandemic flu vaccine and a series of steps aimed at more quickly detecting promising scientific discoveries and getting them to market," the news service writes (Zajac, 8/19).
HHS Secretary Kathleen Sebelius on Thursday "proposed a five-pronged approach for ensuring that the nation has the vaccines and other supplies it needs in the event of an emergency," The Hill's "Healthwatch" blog reports. "The new strategy comes as the Obama administration has questioned the effectiveness of the existing BioShield program, which some lawmakers have proposed cutting by $2 billion" (Pecquet, 8/19).
The proposed strategy is the result of a report by HHS that looked into "the federal government's system to produce medications, vaccines, equipment and supplies needed for a health emergency, known as medical countermeasures," according to an HHS press release. "Sebelius requested the comprehensive review when the department encountered challenges with the 2009 H1N1 [swine flu] pandemic flu vaccine, highlighting the need for a modernized countermeasure production process. The review covered the steps involved in the research, development, and FDA approval of medications, vaccines, and medical equipment and supplies for a health emergency," the release states (8/19).
"The closer we looked ... the more leaks, choke points and dead ends we saw," Sebelius said during a press briefing on the report, Reuters reports. "At a moment when the greatest danger we face may be a virus we have never seen before ... we don't have the flexibility to adapt," she added. "We saw that we needed better coordination not just within our department but across government."
The report calls upon the federal government to "provid[e] clearer guidance to industry on regulatory approval of new drugs and vaccines - something industry has asked for - and says new teams should be set up at FDA to help this," the news service writes (Fox, 8/19).
"The review also found that [the] U.S. must more quickly develop manufacturing processes that can be used for multiple medications or vaccines rather than processes that can be used to produce only one type of countermeasure," according to the HHS press release. "As a result of this finding, in the coming weeks HHS expects to release a draft solicitation for one or more Centers of Innovation for Advanced Development and Manufacturing. The center(s) will focus on new manufacturing platforms that can produce a variety of countermeasures. The equipment and methods could provide a way to meet a surge in demand using facilities in the U.S. rather than relying on foreign manufacturing" (8/19).
"The biggest winners [from the HHS strategy] may be small biotech companies, which often lead the scientific advances but lack the know-how or capacity to get drugs to market," Reuters writes in a separate article, which examines the challenges of drug development (Fox, 8/19). Such challenges include "attracting investors in countermeasures where there is little or no market for these products outside of that currently needed for government stockpiles. As a result of this finding, HHS will explore ways to help small companies attract investors to develop promising countermeasures that have multi-use potential," the HHS release states (8/19).
Reuters continues: To fast track vaccine development, "[t]he report recommends HHS 'support the development of at least three influenza vaccine candidates whose manufacture does not depend on virus grown in eggs or cells,'" the news service writes. The article highlights how some of the lessons learned from HHS' handling of the H1N1 pandemic helped to inform the HHS report (8/19).
The Hill's "Healthwatch" blog continues: "The new strategy calls for a $2 billion investment over the next few years, most of which Sebelius said was already appropriated last year in response to the H1N1 flu. In addition to moving money around, the administration will seek congressional authorization for the creation of the strategic investment fund, Sebelius said. … Coincidentally, the President's Council of Advisers on Science and Technology [PCAST] on Thursday released its plan [.pdf] to improve the nation's vaccine response in the event of pandemic influenza or other outbreaks" (8/19).
The PCAST report "identifies five key junctures where improvements over current practices could contribute to a faster overall response, and specifies those agencies that should receive targeted federal support to accomplish the work of making those improvements," according to a Office of Science and Technology Policy press release (.pdf).