During a House Oversight Committee hearing prior to the congressional recess, Rep. Scott Perry (R-PA) discussed potential national security risks of relying on foreign adversaries for the U.S. drug supply.
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00:00Chair recognize Mr. Perry from Pennsylvania. Thank you, Mr. Chairman.
00:03Gentlemen, thank you for being here. The average life expectancy for Americans is
00:0878 years, despite spending more than every other Western developed country
00:15which has a life expectancy of 82 years, so we're not doing so well. Six in ten
00:21Americans have at least one chronic disease, with more than 40 percent of
00:25children, children suffering from at least one health condition. I just, I think
00:32that's astounding. Mr. Safdar, as of March 31st of this year, the American Society of
00:41Health System Pharmacists lists 238 drugs in shortage. These shortages
00:48include pharmaceuticals used to treat infections, heart failure, psychiatric
00:53conditions, and cancer, and include drugs such as amoxicillin, penicillin,
00:59cisplatin, and active ingredients in most chemotherapeutic regimes. As you probably
01:07know, medications taken by Americans are manufactured largely overseas, and their
01:12active ingredients are overwhelmingly made in Indian and China. Can you explain to
01:18us how our dependence on foreign pharmaceutical markets has created manufacturing delays for
01:24critical medications across the U.S.A.?
01:27Thank you, Congressman, for the question. While I am not an expert in the inspection
01:33of foreign facilities, it is clear that our supply chain is global at this moment, and medicines
01:39come, and the ingredients come from all over the place. We are usually very pleased to see
01:48efforts to secure the supply chain and to secure manufacturing facilities with inspectors from
01:55the FDA, and it is part of what makes our supply chain most resilient.
01:59Do you think it is a good plan for the United States to rely so heavily on other countries,
02:07including ones that consider us their enemy, which would be the Communist Party of China?
02:12Well, the national security implications of that are definitely outside my expertise.
02:18But I think that the doctor here has probably got a better perspective.
02:21Okay, Dr. Kessler, what do you got?
02:22I agree with you 100 percent. I mean, I was in charge of, you know, with my colleagues,
02:30Operation Warp Speed of sourcing for the monoclonal antibodies, for example. We are at risk as
02:40a country. We are not producing in this country essential medicines for life-saving conditions.
02:48We need to do a better job.
02:50So either one of you or anybody, is it because the precursors or the drugs themselves are
02:57rare and unattainable in the United States of America?
03:00If you look at the top universities for chemistry today, nature index, 10 out of 10 are in China.
03:12But is that because they are unavailable in the United States of America?
03:16You need chemists make the drugs, right? Where are they training the chemists? Where is that scientific expertise?
03:24Right? We're not investing in this country in the natural sciences.
03:29So you're saying we have the material, we don't have the know-how. Is that what you're saying?
03:33We don't have the know-how, we don't have the plants, we don't have the commitment.
03:37Do these drug shortages then enhance the proliferation of the illegal knock-off drugs?
03:43Is that a cause-and-effect relationship? We can't get them here, so there are knock-offs produced overseas,
03:53even in our country, that are often dangerous to people in our society that think they're taking
03:57a legitimate drug. They get it on the internet or get it through the mail and then take it and then
04:02overdose. Is that a part and parcel to this?
04:05It is much, it's a much better strategy, right, to have the talent, the expertise,
04:12and the commitment and have those chemicals come from a secure supply chain, right, than
04:21through a lot of different unregulated sources. I mean, you want to lose sleep?
04:28That's what you should lose sleep, about where our medicines are coming from.
04:32Mr. Saftar, does the presence of a strong domestic compounding industry contribute to supply chain
04:38resilience and patient access at any time, but certainly during national emergencies or supply
04:44chain disruptions?
04:45Mr. Congressman, thank you for the question. Yes, as I said in my opening remarks, I think that
04:50there is a critical niche role that compounding plays in our drug supply. But as the FDA has said,
04:57compounded medications are not approved and they're not tested for safety or efficacy, so they should be
05:03used as a last resort. But as you pointed out, if there is a medicine you need for treatment that would
05:08be dangerous to your health to delay, you should definitely take the compounded version if the
05:13normal product, the FDA approved product, is not available.
05:15But what you say seems to imply that they're somehow dangerous. Aren't they manufactured domestically
05:20in licensed facilities with oversight of state boards?
05:23Mr. The FDA has actually been very clear that their safety is not the same as FDA approved drugs,
05:29which should be generics or the branded products, that they take a second tier to safety. They're
05:35not to be used as a first line of treatment. And that's one of the problems we're seeing,
05:40is that we're seeing upstart and unknown and somewhat shady telehealth companies.
05:45You're not conflating compounded drugs made in a facility, in a licensed facility under state
05:51monitoring or oversight with illicit counterfeit drugs, are you? You're not conflating the two, are you?
05:58Mr. That's a whole, no, that's a whole another problem. There's three types of danger that we've
06:02seen in the GLP-1 space. But even a medicine made in a state board of pharmacy or FDA inspected 503b,
06:10for example, outsourcing facility, is not an FDA approved drug. The FDA has given it a status of
06:16being not approved and not tested for safety or efficacy. Now, would I take it if it was that or
06:22skip my cancer treatment? I would absolutely take it. But it's not supposed to be the first line
06:26product. You don't start treatment on it. I understand. Thank you, Mr. Chairman. I yield.
06:30Before I recognize Ms. Brown, I have...