A key element of the Act was to allow stockpiling and distribution of vaccines which had not been tested for safety or efficacy in humans, due to ethical concerns.

Funding also goes toward stockpiling protective equipment, increased surveillance and detection of biological agents, and improving state and hospital preparedness.

United States Department of Health and Human Services (HHS) has taken a number of additional steps to accomplish the goal of effectively and efficiently implementing the Project BioShield Act.

In 2006, HHS announced, in the Federal Register Notice of 6 July 2006, the establishment of the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE).

In February 2018 the Bipartisan Policy Center released a report called "Budgeting for Medical Countermeasures: An Ongoing Need for Preparedness."

According to Homeland Preparedness News, "Daschle and [former U.S. Sen. Judd] Gregg offered budgeting strategies that they believe could lend stability to the MCM arena, some of which would call for changes to statutory processes and congressional procedures that have been implemented since the Project BioShield Act's 2004 enactment.

The Journal of the American Osteopathic Association notes that this kind of testing for biological weapons is ethically unacceptable to conduct on humans.

This discourages other manufacturers from investing research, development and funds in the bioterrorism products to be sold, because the expected profits do not justify the opportunity costs.

The HHS will determine that "...sufficient and satisfactory clinical experience or research data...support(s) a reasonable conclusion that the product will qualify for approval or licensing...within eight years.

[14] Obstacles to pharmaceutical and vaccine development include inadequate funding for research, insufficient protections against corporate liability, and constraints related to safety considerations.

Typically, the drug-development process in the United States is largely initiated by the National Institutes of Health, which supports basic research through funding scientists.

Michael Friedman MD explains that manufacturers of biological defense products could still be "exposed to devastating product-liability suits," adding, "The decision to divert resources from the research and development of medicines for serious illnesses like heart disease can be financially risky, especially when a countermeasure may never be purchased or used."

Friedman argues there needs to be more sponsored research and collaborative programs that engage government, academia, and industry, as well as additional incentives for private companies.