April 4, 2003 - Rep. Henry Waxman questioning FDA Commissioner Mark McClellan about informed consent waivers authorized through Project Bioshield Act.

Posted June 14, 2022. Last updated July 07, 2022.

Today I did a search on my hard drive for “known and potential” risks and benefits, which is the language that appears in Health and Human Services Secretary declarations and FDA authorizations, and the phrase “informed consent.”

The “informed consent” phrase appeared in a transcript of a Congressional hearing held April 4, 2003, chaired by Rep. Henry Waxman (D-California, 1975-2015), and titled: Project Bioshield: Contracting for the Health and Security of the American Public.

The earliest hit on the “known and potential” phrase in documents on my hard drive is the 1997 Emergency Use Authorization (EUA) law in the FDA Modernization Act (Section 402 et seq.)

It’s the phrase that purportedly voids the principle of informed consent for medical treatment, by taking risk-benefit assessment acts away from each man or woman receiving an EUA product, and giving it to the HHS Secretary and FDA Commissioner.

*See 21 USC 360bbb-3(e)(1)(A)(ii) waiving informed consent for unapproved products (2004); 21 USC 360bbb-3(e)(2)(A) waiving informed consent for unapproved use of an approved product (2004). See also 21 USC 355(i)(4) waiving informed consent for experimental products classified by HHS as ‘minimal risk’ drugs (2016); 21 USC 360j(g)(3)(D)(i) waiving informed consent for experimental ‘minimal risk’ devices (2016).

The statutes include language that HHS Secretary may set conditions on EUAs that recipients be informed “of the option to accept or refuse administration of the product, [and] of the consequences, if any, of refusing administration of the product,” which appears to protect a meaningful option to refuse, thus upholding the principle of informed consent as framed by the Nuremberg Code.

However, the Department of Justice and at least one federal judge have interpreted the “consequences of refusal” to mean that recipients may be told by the person demanding that they accept the product, that if they refuse, they will be disciplined, fired or lose their place at school, thus legalizing coercive medical treatment in violation of the Nuremberg Code.

The bait-and-switch maneuver is similar to how the 1997 FDA Modernization Act, read in conjunction with the NDAA passed three days earlier (Section 1078), transferred the US government’s chemical and biological weapons development and testing program from the Department of Defense to the Department of Health and Human Services.

The “known and potential” phrase can be found in several — perhaps all — of the Covid-19 EUA Letters of Authorization issued by HHS since February 2020, for things like masks, PCR tests and mRNA/DNA injections, including the Pfizer/BioNTech letter first issued by FDA Dec. 11, 2020, reissued Dec. 23, 2020, Feb. 25, 2021 and May 10, 2021.

The EUA law has been amended several times since first Congressional adoption in 1997, including in 2004 through the Project Bioshield Act; in 2005 through the PREP Act (Division C at 119 Stat. 2818); and in 2013 through the Pandemic and All-Hazards Preparedness Reauthorization Act.

As far as I know, the Project Bioshield Act was passed as drafted, despite Rep. Waxman’s expressed concerns about waivers of informed consent and other consumer protections, and prohibitions on judicial review. I think the 2005 and 2013 amendments expanded FDA authority and manufacturer indemnity further, while reducing consumer protection and judicial oversight even more, but will need to confirm those conclusions through further research.

In the meantime, below is the text of the informed consent comments and questions raised by Rep. Waxman on April 4, 2003 during a hearing held by the House Committee on Government Reform.

Speakers included NIAID Director Anthony Fauci; FDA Commissioner Mark McClellan; Michael “Heck-of-a-Job-Brownie” Brown, Department of Homeland Security Under Secretary for Emergency Preparedness and Response; and Dale Klein, Assistant to the Secretary of Defense for Nuclear, Chemical and Biological Defense Programs, along with representatives from Aventis Pasteur; Pharmaceutical Research and Manufacturers of America; Avant Immunotherapeutics, Inc.; Alexion Antibody Technologies; and Infectious Diseases Society of America.

---

REP. WAXMAN, opening the hearing:

We are holding a hearing on a proposal by the [George W. Bush] administration which I think all of us would support in its intent. We want to accomplish what the proposal would seek to have us accomplish, but our responsibility as Members of Congress is to scrutinize it carefully, to try to think about the unintended consequences, and to make sure that the job is done right.

The development of effective countermeasures to bioterrorism is certainly vital to our natural security. The Project BioShield represents a proposal to encourage the development of these products. We all support trying to do that, but we have a responsibility to look closely at the provisions of the legislation, and some of those provisions give me some cause for concern.

For example, the proposal removes important protections against waste and abuse that are standard for government contracts. I understand the concern that these protections, in an emergency situation, could impede the development of necessary products. However, any exceptions should be made only when necessary and should be subject to review. This proposal would make it nearly impossible for the courts, for Congress and even the executive branch to rein in abuses. The provision eliminating the government’s access rights to contractors’ books and records is particularly trou- bling.

Another provision permits products to be distributed without FDA approval. Here again, I recognize there may be unusual circumstances that would require this step in case of a dire emergency. However, the proposal’s language is overly broad and could be used to support products that are simply not safe enough for FDA approval. This provision could also permit widespread distribution of unapproved drugs without informed consent, record-keeping or reporting of adverse events.

The BioShield proposal also provides for unlimited guaranteed spending for procurement of vaccines and other countermeasures with little congressional guidance or limits on how much to spend.

This is a blank check approach. It could be looked at as an abdication of congressional responsibility. We should work to improve this proposal in such a way as to preserve oversight and recognize that, in order for BioShield to work, we need to assure that commitments made will be honored.

In this regard, it is ironic that the administration does not support a similar approach of assuring that commitments will be honored in the case of a smallpox vaccine compensation program. Here, the argument for mandatory spending is strong, because nurses, firefighters and other first responders deserve to know that they and their families will be supported in the case of severe injury or death. Yet in the case of smallpox vaccination compensation, the administration has proposed limiting compensation to the amount appropriated each year, explicitly refusing to guarantee its commitment to those Americans on the front lines of a bioterrorist attack. This inexplicable failure to assure funding is one of the reasons that the House voted down the administration’s legislation on smallpox vaccines compensation last Monday.

I raised this issue last week in the Commerce Committee to point out the inconsistencies. At the time I did that, many people raised the point, why should we allow automatic spending in this area? They argued we shouldn’t allow automatic spending in any area.

But Secretary Thompson made the case last week that we want to assure that funding will be there so that the companies that are taking the financial risk of developing these products know that they will be able to count on those funds.

I thought that was a strong argument to make. But, equally strong is to make the assurances clear that if a first responder gets immunized for smallpox that they are going to be able to count on funding should there be, in rare circumstances, but nevertheless in some circumstances, an adverse event.

Let me conclude by pointing out that the BioShield proposal includes provisions for public health emergencies, not just bioterrorism threats. The idea of including public health emergencies in a BioShield makes sense, because infectious diseases that occur in nature can claim many lives, can even become bioterrorist agents if intentionally spread.

What justifies government intervention to support countermeasures is that the market fails to encourage their development on its own. This rationale also applies to the development of treatments for potential public health emergencies.

In 2002, not a single new antimicrobial drug was approved by FDA; and apparently only a handful are in development by major pharmaceutical companies. One reason may be that the market for the few cases of multidrug-resistant bacteria is currently quite small. That leads to a market failure. And yet the need for such treatments is enormous.

Just yesterday, the New England Journal of Medicine carried the first report of a common bacteria that is extremely resistant to an antibiotic that is usually the last line of defense.

If properly designed, then, BioShield can serve valuable purposes, improving our preparedness against bioterrorist attacks and natural epidemics.

I look forward to hearing from the witnesses today to help us understand this proposal and find ways to improve it. We need to work together collaboratively for what is certainly a shared goal that we all have…

---

Rep. WAXMAN questioning FDA Commissioner Mark McClellan:

Dr. McClellan, the BioShield proposal would allow the Secretary of Health and Human Services to waive virtually all of the consumer protections in the Federal Food and Drug Cosmetic Act in case of an emergency. Moreover, the proposal would then severely curtail judicial review of the Secretary’s decision. What is the rationale for allowing informed consent, recordkeeping, adverse event reporting, and other key requirements to be waived; and what is the rationale for severely limiting oversight of these extraordinary powers?

Dr. MCCLELLAN.

The rationale for the emergency use authorization is to provide the most potentially effective treatments to Americans in emergency situations. This is a limited authority program that only applies when the Secretary and others have determined there is a national emergency because of a bioterrorism threat or another type of public health emergency, and it only involves agents where there are not effective approved treatments already available but where there may be treatments in the pipeline where the potential benefits outweigh the potential risks. We have a few now that are marching as quickly as possible toward approval and toward a full demonstration of safety and effectiveness. That remains our goal.

I would highlight that we are going to have even better incentives for that under the BioShield program. You don’t get full payment for development of a countermeasure under BioShield unless it is approved and licensed, fully licensed, fully shown to be safe and effective by the FDA. That is a strong incentive for getting to the finish line that doesn’t exist today and would move us out of the world we are in now, where there are a lot of products that may be of use, but no companies, as I talked about before, are willing to make the investments and come up with the good ideas needed to translate proof of concept into a truly effective treatment.

Mr. WAXMAN. I understand that. That is an important part of why this bill is necessary. But in creating this balance we let the Secretary waive all of these consumer protections, and it looks to me like this authority is quite broad to waive FDA approval standards. Will that give incentives that are needed to conduct the kinds of safety and efficacy trials that are needed, or are some of these companies going to figure they can get around that?

Dr. MCCLELLAN. I agree we need more incentives to conduct the needed safety and effectiveness trials. That is the main reason for the procurement authority for BioShield that only makes payment on delivery of — a full payment for an approved product.

The emergency use authorization does include a number of protections to make sure that in the limited circumstances of the emergency we do as much as possible to limit distribution, limit who can administer, require studies, require recordkeeping and access to records. All of those are elements of the BioShield proposal, and the Secretary would specifically design its use with our recommendations and those of others to do as much of all of those activities as possible.

Mr. WAXMAN. You are giving me assurances that we are not going to pay these companies unless they do what they are required to do, but I am concerned about the broad authority to waive some of the consumer protections like informed consent or making sure we know about the adverse events and other aspects, where right now the law is set up to not just make sure the company does what it needs to do to get paid but the consumers and adverse consequences—the consumers are monitored with and dealt with adequately.

Dr. MCCLELLAN. Right. We want to get to approved treatments as quickly as possible. But with these products in development there may be a number that have been shown to have potential benefits for conditions where there are no effective treatments approved. Under those circumstances, we think it is appropriate, with all of these restrictions in place, to do as much recordkeeping as possible, as much monitoring and standards for production as possible, as much mandatory reporting of adverse events, and informing the consumer, informing the public as possible about appropriate use as can be done under the circumstances. I would be happy to continue to work with your staff to make sure that we tailor that language appropriately.

We think the bill does a pretty good job now of getting as much done as possible on informing consumers, on collecting adverse event data and the like. We think that is very important in the emergency use process. But it is an emergency, and it is a very special limited use condition that requires some special considerations.

---

Martyrdom of St. Vitus.