Table 3.

Similarities and Differences of the Possible Manufacturer Requirements Related to Transitional Subscription and Subscription Contracts Through the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act

Requirement	Transitional Subscription Contract	Subscription Contract
Drug access	No related requirement	Produce the drug at a reasonable volume determined with the Secretary of Health to ensure patient access to the drug
	No related requirement	Price the drug so it is not lower than a comparable generic drug
	Ensure commercial and federal availability in the US of the antimicrobial drug within 30 d of receiving first payment under the contract	Ensure commercial and federal availability in the US of the antimicrobial drug within 30 d of receiving first payment under the contract, and sufficient supply for susceptibility device manufacturers
	Ensure a reliable drug supply chain, where any interruptions to the supply chain will not last for more than 60 d in the US
	Submit a plan for registering the antimicrobial drug in additional countries where an unmet medical need exists
Antimicrobial drug resistance data	Identify, track, and publicly report drug resistance data and trends using available data related to the antimicrobial drug
Widespread education	Develop and implement education and communications strategies, including communications for individuals with limited English proficiency and individuals with disabilities, for healthcare professionals and patients about appropriate use of the antimicrobial drug
Postmarketing studies and utilization	Make meaningful progress toward completion of the FDA-required postmarketing studies, including such studies that are evidence based	Complete any postmarketing studies required by the FDA in a timely manner
	No related requirement	Submit an appropriate use assessment to the Secretary of Health, expert committee, FDA, and CDC every 2 years regarding use of the antimicrobial drug, including how the drug is being marketed
Manufacturing practices	No related requirement	Abide by the manufacturing and environmental best practices in the supply chain to ensure that there is no discharge into, or contamination of, the environment by antimicrobial agents or products as a result of the manufacturing process

Source: [34].

Abbreviations: CDC, Centers for Disease Control and Prevention; FDA, Food and Drug Administration; US, United States.