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 (c) 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
