We Spent a Year Investigating How the FDA Let Risky Drugs Into the U.S. Market — ProPublica

17 years have passed since the spoiled blood thinner from China has suffered or killed hundreds of people in the US, and since then pollutants and other defects have appeared in the cross -section of genetic drugs in America.

To understand how risky drugs can be in our medical cabinets, Propublica spent more than a year Investigation of overseeing foreign factories and medicines Accused of violating critical quality standards. Reporters are mainly focused on factories in India, a key supplier of common drugs in the world.

The investigation revealed how the FDA did not warn the public, allowed more than 150 drugs and their ingredients over the past decades, although they have been made at plants banned here. The agency did not regularly check drugs because they were distributed to the US and actively monitored whether it was harmful to consumers.

The FDA and several former agency officials reported propublica that they believed that the medicines that were released from import ban were safe. They said the agency requires general drug manufacturers to carry out additional quality checks before drugs were sent to the United States, including additional drug security testing and attracting third -party consultants to check the results.

To conduct its analysis propublica used Systems RedicaQuality and regulatory intelligence campaign with a wide collection of agency documents, as well as the Wayback Archive machine to find hundreds of “import announcements” published by FDA for more than 15 years. The list revealed factories prohibited from drug delivery to the US because the FDA revealed production violations.

Studying these lists, journalists discovered references to drugs or raw ingredients that FDA excluded from the prohibitions. The exceptions were mentioned practically without explanation, scattered on frequently long announcements.

Since the FDA does not keep an exhaustive list of medicines that have been released from the prohibitions over the years, Propublica had to build it. Reporters used two different methods for this. For the first time, PROPBLICA wrote a code that used keyword search and comparison of images to pull out drug names and manufacturing places from FDA announcements. Secondly, PROPBLICA used artificial intelligence to get the same information. The results of each analysis were crossed, and the reporters checked each of the results.

Completing its analysis, Propublica estimated all drugs that were released from every prohibited factory. Sometimes the same drug was released from several factories and was added to the total number of factories. In several cases, the FDA released various drugs of the same drug, such as a tablet, capsule or injection. PROPUBLICA considered these different forms as different drugs.

A list of drug drugs released from the ban on imports may be insufficient; No opportunity to learn for sure without full accounting with FDA.

The reporting team questioned more than 200 people, including former FDA inspectors who have repeatedly reported breakdowns in the fields of drug addicts abroad and leading administrators who are directly involved in drug safety. Propublica also received herbs of government and corporate documents in the US and India and filed a lawsuit against the FDA in November after the agency said it would take two years to transfer state -related drugs. FDA has since started to provide some of the requested records; The case operates in the federal court in New York.

Propublica paid Redica for access to the FDA inspection records and ultimately considered reports covering more than two decades.

To evaluate what FDA knew about drugs before and after they were released from import ban, propublica compiled reports from the agency System of reporting on side events. Reports are provided by the FDA with consumers, medical workers, drug addicts and others and used by the agency to identify security and potential damage models. Each contains information about the conditions or reactions associated with drugs, and in some cases complaints about product quality.

PROPUBLICA has identified more than 8,000 drug reports justified from factory prohibitions before and after banned. PROPBLICA analysis included reports from 2010 to early 2025.

FDA warned This information is not verified in the reports, and there can be no “cause -vigilant relations” between drugs and adverse events. Many medicines are sometimes listed in a single report on adverse events. PROPUBLICA limited its analysis of cases in which only one primary drug has been listed.

Some reports do not list specific problems, but instead reference academic studies; PROPUBLICA has turned off these reports.

To study the role of FDA in foreign drug growth, propublica used agency An orange bookA drug register that is considered a safe and effective FDA. The list includes approval for both the brand and genetic drugs, the dates that have been approved by drugs and the names of the applications. The propublica analysis showed that companies with problematic regulatory stories received dozens of permits for the introduction of common drugs in the US – and some continued to get release from import ban.

Journalists have been revealing problems with genetic drugs for years. Book Besselets Catherine Eban 2019, “Bottle of Lies”, Expressed as Indian drug manufacturers did not adhere to basic quality and security standards and often deliberately sent moody drugs abroad. In 2023, A Investigation Bloomberg The cough syrup made in India has spread around the world, among other things. And an independent watchman People’s Pharmacy caused repeated concern about the quality of some common drugs.