Pharma Hearts Big BARDA

And who wouldn’t love a seven-​​foot Amazonian woman lead­ing the Female Furies to save the day? Oh, we’re not talk­ing about the DC comics book char­ac­ter “Big BARDA”? It’s also the name of a new Department of Health and Human Service’s (DHHS) effort? Well, we can talk about that, too.
Last Thursday, the Senate approved leg­is­la­tion within the “Pandemic and All-​​Hazards Preparedness Act” (S. 3678) to cre­ate a Biomedical Advanced Research and Development Agency (BARDA). This par­tic­u­lar leg­is­la­tion has been in the works for about two years as Congress has tried to address indus­try gripes about Project BioShield, the DHHS effort intended to fas­track industry’s devel­op­ment and field­ing of med­ical coun­ter­mea­sures used in the response to a ter­ror­ist CBRN inci­dent.
The biggest chal­lenge to the U.S. gov­ern­ment has been to encour­age indus­try to make drugs that may never be used, and if given out in large quan­ti­ties dur­ing an emer­gency, may be mis­used or abused by the gen­eral pub­lic and/​or pan­icky emer­gency respon­ders. Big Pharma took a look at the risks, the lia­bil­ity insur­ance needed, and the profit mar­gin, and said “no thanks, we’ll stick to cur­ing male impo­tence issues.” However, lit­tle brother Pharma (the small start-​​up labs strug­gling to break out) said “give us an indem­ni­fi­ca­tion agree­ment against future lia­bil­ity suits and make it worth our while and we’ll talk.” In short, that’s what BARDA’s role will be.
The leg­is­la­tion is much more pretty-​​sounding. It says the DHHS Secretary will coor­di­nate the accel­er­a­tion of coun­ter­mea­sure and prod­uct advanced research and devel­op­ment by:

— facil­i­tat­ing col­lab­o­ra­tion between DHHS and other agen­cies, indus­try, acad­e­mia, and other per­sons, with respect to such advanced research and devel­op­ment;
– pro­mot­ing coun­ter­mea­sure and prod­uct advanced research and devel­op­ment;
– facil­i­tat­ing con­tacts between inter­ested per­sons and the offices or employ­ees autho­rized by the Secretary to advise such per­sons regard­ing require­ments under the Federal Food, Drug, and Cosmetic Act; and
– pro­mot­ing inno­va­tion to reduce the time and cost of coun­ter­mea­sure and prod­uct advanced research and development

The leg­is­la­tion also autho­rizes BARDA to exe­cute a $1 bil­lion bud­get, and it lim­its any dis­clo­sure of spe­cific tech­ni­cal data or sci­en­tific infor­ma­tion that is cre­ated or obtained dur­ing the coun­ter­mea­sure and prod­uct advanced research and devel­op­ment car­ried out under sub­sec­tion © that reveals sig­nif­i­cant and not oth­er­wise pub­licly known vul­ner­a­bil­i­ties of exist­ing med­ical or pub­lic health defense against bio­log­i­cal, chem­i­cal, nuclear, or radi­o­log­i­cal threats. That means FOIA or FACA requests would not apply to BARDA work­ing groups or the National Biodefense Science Board.
That part is a lit­tle con­tro­ver­sial, and was one of the main rea­sons why it’s taken Congress two years to actu­ally try to improve Project BioShield. DHHS has awarded a few pro­cure­ment con­tracts for anthrax vac­cines, a bot­u­linum toxin antivi­ral, and potas­sium iodide, but not much else. This leg­is­la­tion will enable BARDA to “help” indus­try through the long, expen­sive process of mak­ing other vac­cines, ones that prob­a­bly won’t have too much use out­side of emer­gency response to the very low prob­a­bil­ity of bioter­ror­ism inci­dents. Needless to say, indus­try loves this idea and can’t wait for the House to agree to the words and print this baby into law.

Passage by the U.S. Senate of this bill, which includes crit­i­cal BARDA pro­vi­sions and pro­vi­sions to reau­tho­rize bioter­ror­ism grants, is an impor­tant and nec­es­sary step toward improv­ing America’s defenses against bioter­ror­ism and pan­demic dis­eases.
This leg­is­la­tion rec­og­nizes that the ‘Valley of Death’ remains a bar­rier to effec­tive coun­ter­mea­sure prod­uct devel­op­ment, and autho­rizes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services. Through BARDA, con­tracts and grants for advanced research and devel­op­ment will be made to com­pa­nies work­ing on prod­ucts to pro­tect the American peo­ple. The bill also con­tains impor­tant con­tract reforms that improve upon the advances made under Project BioShield, by allow­ing, for exam­ple, mile­stone pay­ments and surge capac­ity pro­vi­sions to improve the via­bil­ity and sus­tain­abil­ity of biode­fense prod­uct devel­op­ment and man­u­fac­ture.
Significantly, the Senate-​​passed bill con­tains strong fund­ing lev­els and impor­tant pro­vi­sions to per­mit com­pet­ing com­pa­nies to coop­er­a­tively respond to government-​​declared emer­gen­cies with­out vio­lat­ing antitrust laws.

The “Valley of Death” refers to the time period between industry’s drug devel­op­ment and the FDA’s approval of the drug. The cur­rent BioShield leg­is­la­tion doesn’t award any fed­eral funds until the indus­try firm is pro­duc­ing the actual approved drug, and the small pharma firms just don’t have the invest­ments to make it that long. Thus, like a super­hero rac­ing to the res­cue, comes Big BARDA!
- Jason Sigger

December 11th, 2006 | Chem-Bio, Homeland Security | 23385 Comments »http://defensetech.org/2006/12/11/pharma-hearts-big-barda/Pharma+Hearts+Big+BARDA2006-12-11+15%3A33%3A16sharon_weinberger You can skip to the end and leave a response. Pinging is currently not allowed.