Table 1.

Pending Federal Legislation on Drug Shortages

Feature	House Bill 2245	Senate Bill 296
Short title	Preserving Access to Life-Saving Medications Act of 2011	Preserving Access to Life-Saving Medications Act
Target of legislation	Prescription drug and biological products	Prescription drug products, except those that were originally derived from human tissue and have been replaced by a recombinant product
Terms with definitions	Average historical demand, discontinuance, drug shortage, and interruption	Drug shortage and shortage
Required notifications by manufacturers to HHS Secretary	For planned discontinuance of manufacturing, ≥6 months in advance; for unplanned discontinuance or interruption, ≥6 months in advance or as soon as practicable after manufacturer becomes aware of situation; if manufacturer certifies to HHS Secretary that good cause exists for shorter notification period, <6 months	For discontinuance, planned interruption, or planned adjustment of manufacturing, ≥6 months in advance; for unplanned interruption or adjustment, as soon as practicable after manufacturer becomes aware of situation; HHS Secretary may adjust required time frame
Penalties on manufacturers for failing to submit required notification to HHS Secretary	Civil money penalty of $10,000/day, up to $1.8 million per incident, if failure was intentional; specifics to be stated in regulations by HHS Secretary	Civil monetary penalties to be stated in regulations by HHS Secretary
Required notifications by HHS Secretary to public	Information on actual drug shortages and manufacturing discontinuances and interruptions; also, when possible, estimate of expected duration of shortage, discontinuance, or interruption	Information on actual drug shortages and manufacturing adjustments related to supply of raw materials, production capabilities, business decisions perhaps affecting manufacture of a drug, change in production output, and other adjustments as determined appropriate by HHS Secretary
Notifications by HHS Secretary to manufacturers	When criteria for identifying a drug as vulnerable to shortage have been met	When criteria for identifying a drug as vulnerable to shortage have been met
Criteria for identifying drugs as vulnerable to shortage	Number of manufacturers of drug, sources of raw material or active pharmaceutical ingredients, characteristics of supply chain (e.g., production complexities), and availability of therapeutic alternatives	Number of manufacturers of drug, sources of raw material or active pharmaceutical ingredients, characteristics of supply chain (e.g., production complexities), and availability of therapeutic alternatives
Collaboration	HHS Secretary, manufacturers of drug identified as vulnerable to shortage, and other stakeholders (e.g., distributors, health care providers) will establish and improve plans for “continuity of supply”; such plans cannot prohibit manufacturer from allocating distribution of its products to manage actual or potential drug shortage	HHS Secretary and manufacturers of drug identified as vulnerable to shortage will establish and improve plans for “continuity of operations” for medically necessary drugs
Manufacturing-site re-inspections	––––	If need for reinspection is due to failure to comply with federal Food, Drug, and Cosmetic Act, then re-inspection will occur ≤90 days after company certifies it has corrected problem
Limitations	HHS Secretary may not require manufacturer to make a drug in the event of discontinuance or interruption or to delay or alter discontinuance or interruption	––––
Effective date	1 year after enactment	When enacted
Reports to Congress by HHS Secretary	By 1 year after enactment and every 5 years thereafter on actions taken during previous year to address drug shortages through all parts of supply chain	Annually on actions taken during previous year to address drug shortages through all parts of supply chain
Study by GAO	By 1 year after enactment, report on study of FDA’s identification and response to drug shortages, possible causes of such drug shortages, communication between industry, FDA, distributors, and end users, and legislation’s effects on ability of FDA to identify and ameliorate drug shortages; report will also include identification of additional measures that need to be taken to prevent or address drug shortages	––––

GAO = Government Accountability Office; HHS = Health and Human Services.

From Thompson C. Am J Health Syst Pharm 2011;68:1379–1381. Available at: www.ashp.org/DocLibrary/News/August-1-table.aspx.¹⁷