During a House Oversight Committee hearing prior to the congressional recess, Rep. Andy Biggs (R-AZ) spoke in support of pharmaceutical compounding.
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00:00Chair, I recognize Mr. Biggs from Arizona.
00:02Thank you, Mr. Chairman, and thank you, witnesses, for being here today.
00:06As Congress looks to restore trust in the FDA and crack down on dangerous, illicit products in our drug supply,
00:11it's critical that we distinguish between true public health threats and legitimate medical practices,
00:15such as pharmaceutical compounding.
00:18Compounded medications, when prepared by licensed U.S. pharmacies and FDA-registered outsourcing facilities,
00:24are a vital part of our health care system.
00:26These drugs aren't counterfeit.
00:28They're not knockoff.
00:29They're not illicit.
00:31They're produced legally under rigorous oversight from state pharmacy boards and, in many cases, the FDA itself.
00:37These are personalized medications crafted to meet unique patient needs or to fill gaps in the drug supply,
00:43such as when the FDA added semaglutide injection products, Ozempic and Wegovy,
00:47to its drug shortage list back in March and August of 2022,
00:52prompting compounding pharmacies to step and fill the gap.
00:55Mr. Safdar told Mr. Perry that compounded drugs are manufactured domestically in licensed facilities under the oversight of state boards of pharmacy and the FDA.
01:04But some narratives conflate compounded medications with counterfeit or unsafe knockoff drugs.
01:10It's true that manufacturing standards are the same for compounded outsourcing facilities in the U.S. as those for branded pharmaceutical companies,
01:17and both adhere to the good manufacturing practice system.
01:21Compounded drugs serve a critical role in maintaining access to care, particularly during times of FDA-approved drug shortages.
01:28There was a company in my district that was able to step up during the FDA shortage of semaglutide injection products.
01:35The presence of a strong domestic compounding industry contributes to supply chain resilience and patient access during national emergencies or supply chain disruptions.
01:44Mr. Safdar, your organization, the Partnership for Safe Medicines from 2007 to 2017, was staffed or led by a guy named Scott Laganja.
02:00Is that right?
02:02I believe so, yes.
02:03Did you follow him?
02:05I'm the executive director that came after him.
02:08Yeah. So when you say, I believe so, what you really meant to say, yes, of course I know that was Scott Laganja, right?
02:14You meant to say you knew that he was the guy that was leading your organization before you were, right?
02:18I do not know the exact dates, but I know the end date was 2017 because that is when I started.
02:24So that's a real cutesy response.
02:28And the reality is, you know he was your immediate predecessor.
02:31I do. He is.
02:32He was.
02:33Right. And so I have a series of reports sitting right here.
02:37Before I go through with him, I just want to know, is your funding sources still the same as they were under him?
02:43We are funded by our members and dues from our members, which are listed on our website.
02:48Right. I've gone to your website. I've read them. Do you get money from large pharmaceutical companies?
02:54No, sir. We get money only from our members, and our members are only trade associations or not-for-profits.
03:00So if you're an actual company, a for-profit company, you cannot give us money, you cannot provide us funding.
03:08All right. Very good.
03:09I have here now, Mr. Chairman, this is the following items here.
03:14Article called Nonprofit Linked to Pharma Lobby Works to Block Drug Imports.
03:19Nonprofit Linked to Pharma Rolls Out Campaign to Block Drug Imports.
03:22Nonprofit Linked to Campaign Against Drug Imports is Deep Ties to Pharmaceutical Research and Manufacturers of America.
03:31And then, Mr. Chairman, I have now another one called A New Report Reveals.
03:38It's a blow-by-blow takedown of a report by this organization.
03:44This is produced by the Alliance for Pharmacy Compounding, and it deals with a report issued by Mr. Savdar's company
03:58called A New Report Reveals Illegal Ingredients for Knockoff Weight Loss Drugs Flooding into the U.S. from Foreign Sources Endangering Patient Safety.
04:05Without objection, so ordered.
04:07And then, also, I have a letter from the Alliance for Pharmacy Compounding dated April 8, 2025, that was sent, I believe, to you, Mr. Chairman.
04:17Without objection, so ordered.
04:18Thank you, Mr. Chairman.
04:19I do think that attacks on compounding pharmacies by this particular organization, when we're talking about whether something's a knockoff, illicit, or illegal, or counterfeit drug,
04:33is inapt and unfortunate, and, Mr. Chairman, with that, I yield back the balance of my time.