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May 25, 2024 10 mins
A PHARMACEUTICAL COMPANY IN INDIA RECENTLY FAILED 10 REQUIREMENTS FOR “GOOD MANUFACTURING PRACTICES” FOLLOWING INSPECTION OF THE FACILITIES BY THE FDA. SO WHAT DOES THAT MEAN FOR THE CONTINUING DRUG SHORTAGES? WE SPEAK WITH KENNETH RAPOZA, INDUSTRY ANALYST FROM THE “COALITION FOR A PROSPEROUS AMERICA” AND FORMER STAFF FOREIGN CORRESPONDENT FOR THE WALL STREET JOURNAL.
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(00:00):
You're listening to American Medicine Today,presented by the Benati Spine Institute, featuring
internationally acclaimed inventor of the Benati spineprocedures, Alfred Benati, MD. Once
again, your host Kimberly Burmel Benatiand co host Ethan Yuger. Welcome to
American Medicine Today. I'm Kimberly Benatialongside Ethan Yucker and world renowned orthopedic surgeon

(00:21):
doctor Alfred Benatti. So, apharmaceutical company in India recently filled ten requirements
for good manufacturing practices following inspection ofthe facilities by the FDA. So what
does that mean for the continuing drugshortages? Well, joining us to discuss
is Kenneth Roposa, industry analyst fromthe Coalition for a Prosperous America and former

(00:44):
staff foreign correspondent for The Wall StreetJournal. Thank you for joining us.
Kenneth, thanks having me on certainlyso tell us about this Indian company and
what the violations were. It's everythingfrom what simple sanitation practices to employee training
to purity and quality levels. Isthat correct? Yes? Correct? This
is sort of standard practice for theFDA when they inspect labs, right,

(01:07):
whether in the United States or inIndia, which they don't do as frequently
and certainly don't just pop in toa lab in India like they would here
in the United States. But yeah, the problems were, you know,
if they found contaminants in certain incertain vials, or they would see paperwork
that didn't describe the procedures used tomake the particular drugs, whether it was
a finished drug or API which iseventually going to get ship to United States

(01:30):
and turn into pills or liquid rightlike a liquid benedrill for example. So
they found problems in that. Thisis what zetas pharmaceuticals. But the interesting
thing is about about this whole story, right, is that companies from India
are dominant players in the US genericsmarket, right as you all know.
And the FDA has to carefully balancebetween whether or not we're going to import

(01:53):
these drugs from labs that get essentiallyCNUS and D grades, or we're going
to ban them and risk apply issuesin the United States meaning drugs shortages,
of which I think there are overthree hundred and twenty drugs in short supply
right now because we can't get them. We don't make it in the United
States and we can't get them forwhatever reason in India and China and elsewhere.

(02:15):
Those are the two main places weget them from. So the FDA
is definitely in a rock and ahard place and zeitis. No matter what
you say about that FDA inspection note, they're still selling whatever it is that
they're selling to the United States.Here's what I don't understand. Why can't
we just make some of these drugsor most, if not all, of
these drugs right here in America.What is going on in India and China

(02:36):
where they have access to all ofthese different drugs and can create them,
and then we're at the behest ofpurchasing them from them. And as you
mentioned, the FDA doesn't really overseewhat they're doing overseas very often. So
I guess my question is why can'twe make more drugs here? Well?
Because these generic drugs, the priceplates are very low. So you're looking

(02:58):
at let's say you and I makea drug. Let's let's pick one that
everybody has heard about, a maxacill, And there's only one company United States
that makes the maxiicill, and that'slike a penicillin. If you've had COVID
and you had pneumonia, you probablywould put on a maxiscill and would cleared
up in three days. It's practicallya miracle drug. We only have one
company in Tennessee that makes it,So why don't we make it here?
Because the company in Tennessee probably hasthe profit margin on that drug maybe two

(03:20):
cents three cents, right, andso the margins are very small. And
of course the American medical system isvery is very different than than what it
is elsewhere. Of course, wehave middlemen who change prices, and we
have the insurance industry, so that'sa whole other topic. But in India
and China, especially in India whichis the lead supplier of API and finish
drugs unite generic drugs to the UnitedStates, a lot of those guys are

(03:42):
subsidized by the state. Okay,because that has been an industry that India
has wanted to promote and become anational champion sector of the economy so to
speak, like it is or hasbeen for India for since probably the nineteen
nineties. Now it's generic drugs isanother aspect of that. So they were
able to do those what they cando of course they don't pay their labor
like we do. Obviously that's thecase in any country in the developing world.

(04:06):
But they are able to get helpfrom the government and that covers any
sort of margin issue that an Americanlab would not be able to compete on
those margins alone. So this iswhy the industry has really fled to low
cost countries, you know, becausethe margins are so low here. And
the reason these guys in India cando it again is because it doesn't matter

(04:27):
on the margin. They get anykind of subsidy they can get from the
government to keep them in business ifthe margins were too low on a particular
drug. One thing I wanted togo back to what you said is this
company was still bringing in these drugs. So what did really the FDA calling
them out and failing them on tenrequirements, What did that really accomplish if

(04:48):
the drugs still came in, Right, All it accomplished was the lab in
India says, we got to getthese better. So one day when the
FDA inspects again a year later,right, they don't say, Okay,
you're not going to be put onwhat's called an impolar, which means you're
banned. We're going to send youa strongly worded letter, which is an
FDA lingo is called a warning letter, and that could lead to an impolar

(05:11):
But again, the FDA is balancingsupply issues and safety all the time,
and unless a drug is going tocause serious harm, then they are more
apt to say let it in.But hey, lab director, make sure
you clean up your act for thenext time so we don't have to ban
you, because we don't want toban you. You just doesn't want to
ban. But you just said therewere contaminants in it. So how does

(05:33):
that play out for the people takingthose drugs? Well, I think it
plays out. It depends how seriousthe contaminants are. Right, And this
is an issue because I was ina hearing yesterday. It was the House
Subcommittee on Health and they had twoofficials from the FDA in there, and
you know, they basically will tellyou, we have no authority to go

(05:54):
tell a lab no matter where itis Israel, Ireland, Germany, China,
India, to say hey, yourdrug cannot come to the United States
because what we discovered wasn't good unlessit's really bad. Right, They discovered
an immense amount of contaments in thedrugs or an inspection, they will shut
it down. That happens rarely,but it happens all the drug recalls you
hear about in the news. That'sall voluntary. So it's the lab in

(06:16):
India or where again, wherever itis, including a lab maybe in Wisconsin
says, oops, we found acontaminant hair some extra I think the word
is. I can't think it nitrosaminesor whatever. It is, some sort
of carcinogen in the drug above acceptablelevels, okay, because there are acceptable
levels, and there's above acceptable levels, and then they would say we're going

(06:39):
to pull this drug. So FDAis dependent on the goodwill of these labs,
be there in the United States orforeign. We're gonna highlight the foreign
ones because that's where most of ourgeneric drugs come from. As you know.
Last year, something as simple aseye drops made from India. I
don't remember the company's name, butthey were responsible for at least one or
two depths. So these are overthe counter medications. So you know,

(07:00):
these are things that you know theFDA where they inspected that lab or not,
and I'm sure they did maybe ayear ago. Unless they went to
the lab and saw some sort ofcontaminant in the eye drop. It's up
to that lab to say, oops, we've found something wrong. We're gonna
pull it. And when they don'tpull it, well, then you take
it and you hope that everything's goingto be okay. I wonder myself,

(07:21):
actually, if some of the drugsthat come in from overseas are anywhere in
general, if we are relying onthese voluntary recalls, which seems to be
the only way that the FDA isgoing to say that we can do this
without tripling our manpower to inspect allthese things and decide what comes in and
what doesn't. That sometimes Americans aretaking daily prescription drugs that aren't exactly what

(07:45):
they're supposed to be in terms ofthey're not as effective as they're supposed to
be. They do have a smalleramount of contaminants that are allowed and taking
them over time that just doesn't helpmatters. So it's a very tricky situation.
The FDA is absolutely in a rockand a hard place because they have
to balance those two things, safetyand supply. And I say says about
three hundred and twenty drugs that wetake regularly or that hospitals use every day

(08:07):
in surgeries that we don't make here, and so they're relying on these foreign
labs to say, oops, wemade a mistake or not, and then
those drugs get sent into the Americansupply chain. You know, I am
I'm really tired to listen all thetime excuses for bad behavior, and this
is becoming a custom in the UnitedStates. We always talk about situations and

(08:31):
then we encourage these situations to persist. And I really think that it's not
American. That is not the waythat we work here. And if we
need more money to supervise these things, we pay a tremendous amounts of taxes
here that we pay so many taxesthat these taxes are supporting the wars and

(08:52):
the stupidity in other countries. Butwe cannot fix by law laboratory problems and
things that we are going to consumehere. That is ridiculous. Not only
ridiculous, it's totally un American.Well, let's not forget that the FDA
is majority funded by labs here inthe United States, or FDA registered labs
who pay you know, pharmacutical druguser fees right in order to participate in

(09:16):
selling drugs in the United stations beregistered. You though you got to pay
a user fee authorization, you knowyou got to pay that. Then we
need to solve that problem. Wecannot help somebody that is being in that
situation and is playing with the healthof the of the population. We need
to be totally independent, and thatindependence needs to be maintained. Cannot be

(09:37):
a legal behavior where the FDA willbe practically shackle just only because the laboratory
people are paying them. They shouldbe totally independent, and it should be
with the with the power to beable to make a decision that is going
to affect these people, because ifyou don't do that, then you're killing

(09:58):
the population here or otherwise you're usingmoney in other countries that they are bringing
here things that we shouldn't be using. I think this is absolutely ridiculous.
Big pharma and lobbyist are definitely theproblem. Thank you so much for shedding
light on this, Kenneth Roposa.Thank you for being on the program.
You're welcome than I appreciate. Thankyou for listening to American Medicine today.

(10:22):
We'll be back next week with more. If you would like to hear any
of our other programs, you cansearch iHeartRadio app keyword amt or keyword Benati,
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