Grassley at Hearing on Foreign Drug Manufacturing Inspection Oversight
Statement by U.S. Senator Chuck Grassley of Iowa
Chairman, Senate Finance
Hearing on COVID-19 and
Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process
Tuesday, June 2, 2020
like to welcome everyone to the Finance Committee’s oversight hearing on the
Food and Drug Administration’s (FDA) foreign drug manufacturing inspection
committee has an obligation to ensure drugs paid for by the taxpayer via Medicare
and Medicaid satisfy quality standards and are safe and effective for patients.
responsibility, both of Congress and the FDA, is heightened now that we are
living through the COVID pandemic.
we are in the midst of a pandemic or not, these supply chain issues must be
shored up and solved.
June of last year, I began my oversight activities on this issue.
wrote letters to Secretary Azar and then Acting FDA Commissioner, Dr. Sharpless.
asked a series of questions relating to manufacturing facilities overseas that
manufacture final dosage form drugs and active pharmaceutical ingredients
also asked about how the FDA manages its foreign inspections regime.
Government Accountability Office has said that the FDA does conduct some
unannounced inspections overseas but they don’t have data on frequency.
GAO noted in 2019 that the FDA estimated that they generally provide twelve
weeks of notice before the inspection.
said, you’re undermining the ability of field inspectors to do their job.
Twelve weeks is plenty of time to doctor up a facility to make sure that it
incredibly, some facilities still get caught. That’s how bad it is.
end result is that the consumer is put at risk.
to the most recent FDA data, the United States has 46 percent of finished
dosage form facilities. That’s where APIs are turned into the final form such
as a tablet.
means over 50 percent of sites manufacturing finished drugs are located
that’s just part of the story. What we really need to know is where did the API
to the most recent FDA data, 13 percent comes from China, and 19 percent comes
from India. Combined, that’s more than any other country. And overall, more
than 70 percent of facilities that make APIs are located overseas.
figures, coupled with the COVID pandemic, have garnered a lot of attention,
including what might need to be done from a national security perspective.
the figures do make clear what needs to be done from a drug safety perspective
– we need to have a robust and aggressive foreign inspections program.
with respect to China and India, both those countries have had serious quality
all remember the valsartan recall where that drug was found to contain
contaminants used in rocket fuel.
in China and India produced that drug.
not forget about the Heparin scandal either.
that case, patients undergoing dialysis began to have severe and life
threatening side effects because a manufacturing plant in China introduced a
toxin into the production chain.
of people died and hundreds were sickened.
we have Ranbaxy, an Indian manufacturer.
production chain exposed drugs to potential cross-contamination by penicillin
and used APIs from facilities that were not approved by the FDA.
also manufactured Lipitor, and was shut down because it could not explain why
some of those tablets had pieces of glass in them.
fear these examples are just the tip of the iceberg.
show why the FDA must maintain an aggressive inspections regime to ensure drug
quality but also impose a strong enforcement regime on bad actors.
February of this year, FDA Commissioner Hahn told me that in Fiscal Year 2018
the Center for Drug Evaluation and Research issued almost five times as many
warning letters to human drug manufacturers as compared to 2015.
said that’s a sign that FDA is better able to use its resources to identify
problems. Good. Stay aggressive and don’t hesitate to be more aggressive.
the front end, though, that process should include unannounced inspections
overseas. After all, why would we give manufacturers time to prepare their
facility for inspection?
ought to be looking over their shoulder every day. That keeps them honest.
the Obama administration, the FDA started what was called the India Pilot
allowed for no warning inspections or a couple days’ worth of warning.
it, the FDA issued a 60 percent increase in “Official Action Indicated” findings.
2015, the Obama administration shut the pilot program down without explanation.
sounds like the program was a victim of its own success.
this issue is bipartisan. Republican and Democrat administrations have come up
Government Accountability Office has a body of work from multiple
administrations that proves it.
example, both the Obama and Trump administrations have struggled to fill
vacancies in foreign offices.
we have witnesses from the FDA that can speak to all of these issues and how
the pandemic has impacted their work.
the first panel, we have FDA witnesses and a GAO witness.
the second panel, we have private sector companies.
you for being here.
important to note that I plan to follow up with another hearing soon examining
another problematic aspect to our medical supply chain, specifically the
increase in trade of fake and faulty personal protective equipment.
is separate from what we will discuss today.
closing, I want to say two things.
thank you to the FDA officials that work tirelessly to inspect facilities
regardless of party, we must have an honest discussion of the government’s
shortcomings so that we can better understand what we, as Congress, can do to
ensure drug safety for the taxpayer.
all, we work for them and must always answer to them.
I’ll turn to Ranking Member Wyden.