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The U.S. Food and Drug
Administration’s campus in Silver Spring, Maryland <span
class="attribution__credit"> Credit:  AP
Photo/Jacquelyn Martin, File

Health Care

After Pandemic Delays, FDA Still Struggling to Inspect Foreign Drug Manufacturers
=================================================================================

In the wake of recent deaths from bacteria-tainted eyedrops, a ProPublica analysis of FDA data reveals that the agency only inspected 6% of the overseas plants where drugs and their ingredients are produced in 2022.
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


by
Irena Hwang
April 19, 12:15 p.m. EDT
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For years, U.S. pharmaceutical companies have relied on drugs produced
overseas to meet Americans’ medical needs. And for years, it’s been
clear that federal drug regulators couldn’t keep up with inspections of
the plants that made those drugs.

But a series of recent deaths linked to eyedrops produced overseas that
were tainted with bacteria points to just how seriously behind the Food
and Drug Administration is. [Three people died and eight others were
blinded](https://www.cdc.gov/hai/outbreaks/crpa-artificial-tears.html)
in the United States from the drops, which were made in a plant in the
Indian state of Tamil Nadu that the agency had never inspected prior to
the outbreak. Worse, public health officials say they have detected the
drug-resistant bacterial strain, which had never been seen in the U.S.,
among patients who never used the eyedrops, meaning it has likely
[achieved community
spread](https://www.nytimes.com/2023/04/03/health/superbug-eyedrops-blindness.html).

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A ProPublica analysis of [FDA inspection
data](https://datadashboard.fda.gov/ora/cd/inspections.htm) as of April
shows that the agency’s inspections of overseas drug manufacturers,
located mostly in India and China, has dropped precipitously even as the
number of manufacturers has remained relatively steady. In fiscal year
2019, the year before the COVID-19 pandemic limited travel and movement,
the FDA inspected 37% of the nearly 2,500 overseas manufacturers; in
2022, the agency only inspected 6% of around 2,800. And in India, where
the contaminated eyedrops originated, the FDA inspected only 3% of
manufacturers in 2022 — significantly less than in 2019, when 45% of
plants were inspected.

The FDA, which is tasked with ensuring the safety and efficacy of both
prescription and over-the-counter drugs, has acknowledged that limited
resources make it impossible to inspect every plant, whether in the U.S.
or not, that makes drugs or their ingredients. But the agency has been
slow to make improvements.

This is not the first time that American consumers have been injured or
killed as a result of contaminated drugs produced overseas. In the
1980s, drugs manufactured in Italy intended to prevent seizures resulted
in epileptic seizures and two deaths. In 2007 and 2008, hundreds had
allergic reactions, some fatal, to a commonly used blood thinner,
prompting an FDA investigation. Some of the cases were later linked to
an ingredient produced in a facility in China that had never been
inspected by the FDA.

The Government Accountability Office, a federal watchdog agency, has
warned for decades that the number of overseas inspections was
worryingly low. Just weeks before the first cluster of COVID-19 patients
was reported in China at the end of 2019, the GAO reported that despite
some improvements in how the FDA tracked and prioritized its efforts,
[inspections of both foreign and domestic drug plants were on the
decline](https://www.gao.gov/products/gao-20-262t), due in large part to
challenges retaining staff and filling vacancies.

“While our drug supply is generally safe, problems do occur, as
evidenced by contaminated eye drops in the last few months,” said Mary
Denigan-Macauley, director of public health at the GAO. “No one wants to
lose their vision or an eye simply from taking eyedrops to alleviate dry
eyes.”

Without a doubt, the COVID-19 pandemic slowed inspections to a trickle —
in fiscal year 2021, according to the data, the agency inspected a mere
99 overseas sites, less than 4% of eligible foreign manufacturers. By
comparison, 15% of domestic manufacturers were inspected that year.
(Nearly three-quarters of manufacturers of U.S. drug ingredients, and
more than half of producers of finished drugs, are located overseas.)

During the pandemic, the FDA [began announcing domestic
visits](https://www.fda.gov/drugs/coronavirus-covid-19-drugs/manufacturing-supply-chain-and-drug-inspections-covid-19)
beforehand and paused surveillance visits overseas except for those
deemed “mission critical,” conducting most preapprovals of new drugs
without visiting foreign manufacturing sites.

The FDA defended this decision in an email statement to ProPublica,
saying it used “alternative inspectional tools such as remote
interactive evaluations, record requests, and leveraging information
from trusted regulatory partners.”

Both the GAO and Rep. Sanford J. Bishop, a Georgia Democrat, say these
remote interactions do not offer the same insight that in-person,
unannounced inspections do. The FDA itself affirmed the utility of
inspections in its [latest annual report on pharmaceutical
quality](https://www.fda.gov/media/161172/download): “In the absence of
inspections, many of these situations” that could result in defective
products, “and possible public harm, could have gone undetected.”

But three years after the pandemic started, the FDA has been slow to
return to pre-pandemic inspection rates. The pandemic heightened the
urgency surrounding the FDA’s drug inspection process, as the need for
more equipment, vaccines and antiviral medications, many of which are
produced overseas, increased. Though routine domestic surveillance
inspections resumed in July 2021, routine foreign inspections remained
on hold until February 2022.

In December, President Joe Biden signed a year-end spending package that
allocated $10 million for a pilot program to “increase unannounced
foreign inspections” of drug makers. But that was just a tiny fraction
of the $3.5 billion earmarked for all FDA drug quality oversight
programs.

“We have got to be protective of the health, safety and welfare of the
American people,” said Bishop, who pushed for funding for overseas
inspections in the House. “That is the job of the FDA.”

Experts hope the pilot program will address standards surrounding those
visits, which have drawn criticism for being too permissive. Unlike
domestic inspections, foreign manufacturers were routinely given a
heads-up before an inspection and allowed to provide their own
translators, practices that FDA inspectors have admitted could make
information gathered unreliable. The FDA said that it planned to use the
additional $10 million to increase staffing for foreign inspections and
to work on prioritizing inspections that the agency was unable to
perform during the pandemic.

Among the foreign establishments never inspected was a Global Pharma
Healthcare factory in Tamil Nadu that produced artificial tears sold by
U.S. companies EzriCare and Delsam Pharma. As an over-the-counter
product that does not require FDA approval, the eyedrops fell into
another FDA regulatory blind spot. Though the FDA has the authority to
inspect manufacturers of over-the-counter products before they are sold
to consumers, there is no requirement that an inspection must occur
prior to the sale — unlike for prescription drugs.

The FDA is asking Congress to require that manufacturers notify the FDA
of their intent to distribute over-the-counter drugs well in advance of
selling them, potentially providing the FDA a “feasible opportunity” to
conduct inspections.

ProPublica

Read More




**New York Prosecutors Ignored Tainted Evidence Used Against
Spanish-Speaking Drivers for Years**

But even that requirement might not have made much of a difference.
According to the GAO’s [2022 report on FDA foreign
inspections](https://www.gao.gov/products/gao-22-103611), a growing
backlog of manufacturers slated for routine surveillance inspections is
skewing in a concerning direction. The percentage of overseas
manufacturers that hadn’t been inspected within five years, or which
have never once been inspected, has grown from 30% in 2020 to more than
80% in 2022. And if the FDA prioritizes sites that have not been
inspected recently, that might come at the expense of inspecting sites
identified by the FDA as posing the highest public health risk.

Preventing future public health risks, like the ongoing eyedrop
outbreak, has to be a priority, said Denigan-Macauley of the GAO.

“These problems are not hypothetical. They are real,” she said.

In the case of the imported tainted eyedrops, in January, the FDA and
the Centers for Disease Control and Prevention traced back the
Pseudomonas aeruginosa outbreak to the Global Pharma Healthcare-produced
EzriCare Artificial Tears. That same month, the FDA requested records
from the manufacturer regarding an unrelated issue and, concerned by
Global Pharma’s “inadequate response,” placed it on an import alert,
preventing its products, including the eyedrops, from entering the U.S.
In early February, the FDA recommended a recall of the EzriCare and
Delsam Pharma eyedrops, though it waited weeks to finally conduct an
on-site inspection, only to find multiple sanitary and safety issues.
The companies did not respond to a request for comment, though in a
February press release EzriCare said that [it was cooperating with the
CDC and FDA](https://ezricare-info.com/). Global Pharma has said to [The
New York
Times](https://www.nytimes.com/2023/02/02/business/eye-drops-ezricare-infections-cdc.html)
it is “fully cooperating with U.S. federal authorities.”

**Filed under —**

-   Health Care

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Irena Hwang
Irena Hwang is a data reporter at ProPublica.

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