Go BARDA! – Misguided Criticism of Good Efforts

posted in: Other Transactions | 0
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The Biomedical Research and Development Authority (BARDA) of the Department of Health and Human Services (HHS) has been engaged in coming to grips with serious issues that challenge the health of our nation’s citizens as well its economy and national security. Most immediately this includes dealing with COVID-19. In addition, DOD has joined in partnering with HHS to address these issues. It should be no surprise that BARDA has employed its Other Transaction (OT) authority to expedite and streamline its efforts.

Amazingly the director and general counsel of a so called public interest group (none of which merit being named in this article) are co-authors of a briefing paper that lambasts BARDA’s efforts. The briefing paper is an example of poor legal research and a biased point of view dominating facts. As many readers of my articles will know publication of misinformation and uniformed or biased views of OTs are not uncommon.

I would not have been aware of the paper had its link not been sent to me in an e-mail from a colleague. I would have ignored it as inconsequential except for having stumbled across a YouTube diatribe by Senator Patty Murray (D-WA) which seemed to have been influenced by it. If our legislators are influenced by uninformed opinions on subjects of importance perhaps something should be said.

As an example of the poor quality of research the text of the paper says referring to me “Dunn advises…”. It then goes on to attribute words to me which I never spoke. The accompanying footnote cites an article on the Strategic Institute website of which I am not the author. Another quote is a statement in a law student law review note describing something which is quoted in a DOD OT Guide dating from 2002 which is not the source document. The uncited source document (a USD (AT&L) memorandum) is available on-line for those who want to find it. Citing a tertiary source when the primary source is available is shoddy legal writing and research. 

The paper talks about “protections” for the taxpayer missing from OTs. First, OTs can incorporate any clause or perceived “protection” of a FAR contract if it makes sense. Most do not, because many so called protections are just arcane process/overhead that add cost but no value to the desired goal. DOD’s studies have documented this.

Reminiscent of the FCS Myth article on this website, the paper quotes a letter from Sen. McCain to the Secretary of the Army in 2005 stating that OTs were only intended for small research projects with non-traditional companies. This is the line taken by another so-called public interest or watchdog group and its witness Kenneth Boehm in McCain’s 2005 AirLand subcommittee hearings on FCS. When the original OT authority was enacted in 1989 McCain was a very junior Senator who had nothing to do with the enactment of OTs or their initial use. He had nothing to do with their expansion to prototype authority for weapons and weapons systems. Sen. Warner (D-VA) was then ranking Republican member of the Senate Armed Services Committee (SASC) and he was engaged in the floor colloquy that was the basis for enactment of prototype authority. Predictably the paper does not note that when Sen. McCain rose to chairman of the SASC he supported legislation to broaden prototype authority and add a simplified method of follow on production. The Senator had learned something, but the authors of the paper have not being mired in their own misinformed point of view. 

Sen. Murray’s rant on YouTube is interesting. She focused on patent March in Rights under the Bayh-Dole Act. She asserted industry was dictating terms of OT agreements. Apparently Sen. Murray has not heard of negotiations. No doubt she prefers one-size-fits all government rules rather than thoughtful discussions and negotiations. Aside from the fact that exercising march in rights has not been found practicable and has hardly ever been invoked, Sen. Murray has failed to note a key point. By its very terms, the basic allocation of rights under Bayh-Dole as well as specifically march in rights do not apply to a large company such as a major pharmaceutical manufacturer.

The operative language in title 35, U.S. Code is:

  • 203. March-in rights
  1. With respect to any subject invention in which a small business firm or nonprofit organization has acquired title under this chapter, the Federal agency under whose funding agreement the subject invention was made shall have the right… [emphasis supplied]

This was modified after President Reagan’s policy memorandum of 1983 by an amendment to section 210. That does not change the fact that march-in rights are virtually never used. Mindless criticisms whether in a purportedly academic paper or by a U.S. Senator are not helpful in our current situation. Business as usual should not be the baseline for responding to a crisis whether it be in health, national security, or the economy.

HHS and DOD are cooperating in Operation Warp Speed to field a vaccine and therapeutics in response to Corona Virus. They may not get everything right. Defaulting to the “costs too much, takes too long” traditional system is not the way to go. One size fits all is not the way the go. Other Transactions open an alternative path to better, quicker and more affordable outcomes. Old thinkers like the approach which as former Sen. Jeff Bingaman used to say, “spends millions to save thousands.” 

Let us reject shoddy legal research and biased conclusions as well as politically motivated rants and let people who have a job to do get on with it.


written by Richard L. Dunn