FDASIA and early notice of drug shortages

In 2025, 167 manufacturers sent FDA 1,424 notices of potential drug and biological product shortages. The agency says it helped prevent 330 shortages that year, and it counted four new ones, according to its annual report to Congress¹. In 2011, before the current reporting rules existed, FDA logged 251 new shortages.

Most of that change runs through one section of federal drug law. Section 506C of the Food, Drug, and Cosmetic Act tells manufacturers to warn FDA before production of an important drug stops or stalls. Congress rewrote it in the Food and Drug Administration Safety and Innovation Act, known as FDASIA, signed July 9, 2012, after the shortage wave described in our history of the 2011 crisis and the executive order.

This explainer walks through what the 2012 law requires, how FDA's 2015 regulation filled in the details, what the agency does with a notice, and how to read the prevention counts FDA reports each year. Those counts are FDA's own tally, and the method behind them has shifted, so the year-by-year table below carries caveats.

What the 2012 law changed

FDASIA did not invent the early-warning idea. A 1997 law had added section 506C, but its reach was narrow. According to FDA's 2013 strategic plan⁸, the old version applied "only to sole manufacturers; only to a discontinuance (which could be read to imply a permanent shutdown); and only to certain approved drugs." A December 2011 interim final rule¹⁴ stretched those terms as far as FDA thought the statute allowed.

Section 1001 of FDASIA⁹ replaced the section outright. The comparison below uses the strategic plan's description of the old law and the current text of 21 U.S.C. 356c¹⁰.

Elsewhere, the same title of FDASIA ordered an annual report to Congress, a task force and strategic plan, and a public shortage list, now section 506E. The annual report is due by March 31 each year under section 506C-1¹¹, which is why the year-by-year figures in this piece exist at all.

Which drugs are covered

The duty applies to a manufacturer of a prescription drug that is "life-supporting," "life-sustaining," or "intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery," in the words of the statute¹⁰. Radiopharmaceuticals are excluded. FDA's regulation for drugs sold under an ANDA or NDA sits at 21 CFR 314.81(b)(3)(iii)¹², with parallel rules for unapproved drugs (21 CFR 310.306) and biologics (21 CFR 600.82).

What triggers a notice is a "meaningful disruption." The regulation defines that as a change in production "reasonably likely to lead to a reduction in the supply of a drug by a manufacturer that is more than negligible and affects the ability of the manufacturer to fill orders or meet expected demand." Routine maintenance and minor changes do not count "so long as the manufacturer expects to resume operations in a short period of time."

What the 2015 rule added

FDASIA told FDA to write a final rule. It arrived on July 8, 2015¹³, took effect Sept. 8, 2015, and replaced the 2011 interim rule. Three provisions do most of the work.

First, a hard backstop on timing. If six months' notice is not possible, the rule requires notice as soon as practicable, "but in no case later than 5 business days" after the discontinuance or interruption. FDA wrote in the preamble that a firm able to notify sooner but waiting until the fifth day "is in violation of the rule."

Second, minimum contents. Each notice must give the drug's name and National Drug Code, the applicant's name, whether it is a permanent discontinuance or an interruption, the reason, and the expected length of any interruption.

Third, the enforcement path. Under section 506C(f), FDA sends a letter; the firm has 30 calendar days to answer; FDA posts both within 45 days unless the letter was a mistake or the firm had a reasonable basis for not notifying. In its regulatory analysis, FDA estimated annual reporting costs of up to $16,827 for affected applicants and up to $441,000 in FDA review costs.

Letters have been rare. FDA has issued 11 since 2014 and none in 2024 or 2025, according to the CY 2025 report¹.

What FDA does with a notice

Once a notice arrives, FDA's Drug Shortage Staff checks whether national supply can absorb the loss. The agency's shortage FAQ¹⁵ describes the test as whether "on a nationwide level, supply is not meeting current demand." If a shortage looks likely, section 506C(g) directs FDA to prioritize and expedite reviews of applications and supplements, and inspections, that could help. For controlled substances, the statute gives FDA 30 days to determine whether a notice involves a drug under a production quota and, if needed, to ask the Attorney General to raise the quota, a process covered in our piece on DEA production quotas and shortages.

FDA's 2025 report gives a sense of scale. Its drug center counted 1,355 notifications from 129 manufacturers and recorded 206 expedited reviews, 164 of them for ANDAs or ANDA supplements, plus 10 expedited inspections and 71 uses of "regulatory flexibility and discretion." The ANDA side of that work connects to how FDA prioritizes generic applications. A permanent discontinuance that FDA cannot offset often shows up as a "to be discontinued" entry, explained in our article on discontinued drugs on the shortage list.

The yearly numbers, and how to read them

Sources: FDA reports to Congress for 2017⁷, 2018⁶, 2021⁵, 2022⁴, 2023³, 2024² and 2025¹; 2011 and 2012 from the 2013 strategic plan⁸. Notification counts cover drugs and biological products.

Read the middle column with care. "Prevented" reflects FDA's own judgment that its actions kept a potential shortage from happening, and the reports do not describe any outside verification. Through 2015 the count was CDER's alone; from 2016 it includes the biologics center, a change the CY 2021 report⁵ spells out. The 2017 report gives two different 2017 totals, 145 and 135, in different sections; later reports use 145.

New-shortage counts are cleaner, and their decline is steep. Ongoing shortages are the stubborn part. FDA identified 93 still unresolved at the end of 2025, and it attributes their persistence to market conditions, including "lack of incentives for firms to manufacture older, less profitable products." The current picture is on our shortage tracker and in our snapshot of what FDA's list shows in November 2026.

What came after

Section 506C kept growing. The 2020 CARES Act extended the notice duty to active pharmaceutical ingredients and added risk-management plans and annual production reports, all covered in our explainer on the CARES Act and shortage reporting. FDA's report on shortages in 2026 is due to Congress by March 31, 2027.