Raskin Advocates For FDA To Carry Out Mission Based ‘On Sound Science— Not Conspiracy Theories’

6 months ago

During a House Oversight Committee hearing on Thursday, Rep. Jamie Raskin (D-MD) gave opening remarks about the FDA.

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Transcript

00:00I now yield to Ranking Member Raskin for his opening statement.

00:05Thank you very much, Mr. Chairman, and thank you to Commissioner Dr. Kalaf for being with

00:10us here today.

00:13The FDA regulates everything from bottled water to infant formula, meat, poultry and

00:19egg products, prescription and non-prescription drugs, vaccines, medical devices, microwaves,

00:27dental care products and tobacco.

00:30During the Biden-Harris administration, the FDA has made critical progress to ensure that

00:36we have access to safer food and to effective drugs.

00:40For example, last fall FDA acted quickly to investigate reports of lead appearing in children's

00:48cinnamon applesauce packets for their school lunch.

00:53The cinnamon was adulterated with lead, which was added by the manufacturer in order to

01:01increase the weight of the product to make it more profitable in the process.

01:08However, the applesauce contamination issue could have been completely prevented if end

01:15product inspections for food were required.

01:19The FDA asked Congress to amend the Food, Drug and Cosmetic Act as part of the FY 2024

01:27budget request to require that industry conduct testing of final products exactly for such

01:33contaminants and provide FDA immediate access to those results.

01:38This would greatly help to ensure the safety of all of our food products for kids and for

01:43everyone else.

01:45But the FDA needs these additional authorities to make that happen.

01:51And, Mr. Chairman, I was very pleased to hear your opening comments, and I hope you would

01:55join me in supporting giving the FDA additional regulatory authority precisely to address

02:02the kinds of problems that both you and I have identified.

02:06The FDA itself has proposed multiple solutions that would address the problems we are talking

02:11about today.

02:12The Democrats support greater and more refined regulatory authority to make our food and

02:18drugs safer, and we hope our colleagues will join us.

02:22In the wake of infant formula and prescription drug shortages, FDA also advanced legislative

02:29proposals earlier this year to strengthen notification requirements and data sharing.

02:35Right now, they don't have any authority to tell drug manufacturers to produce more drugs.

02:41One proposal they have offered would require manufacturers to notify the FDA, dealing with

02:49this first problem of the applesauce, would require manufacturers to notify FDA about

02:54pathogens that are discovered in certain critical foods.

02:58In the case of infant formula, this authority would help FDA prevent contaminated infant

03:04formula from reaching any more consumers and babies.

03:08The second proposal they have suggested would expand FDA's authority to gather data from

03:13industry about potential drug shortages and supply chain disruptions.

03:20FDA has improved access to contraception and protections for medication abortion access.

03:27In 2021, FDA advanced the accessibility of medication abortion by removing the in-person

03:33dispensing requirement for mifepristone and allowing it to be distributed by mail through

03:38retail pharmacies.

03:39In July 2023, FDA approved the first over-the-counter birth control pill, Opil.

03:46As a result, consumers' access to contraception is improved at a critical time when many States

03:51are enacting increasingly draconian and oppressive abortion restrictions.

03:57FDA has also made advancements to combat a range of life-threatening diseases.

04:02In March of last year, FDA approved the first OTC opioid overdose reversal medication, Naloxone

04:10nasal spray, a critical step towards reducing opioid overdose deaths in our districts.

04:17FDA also recently approved new genome editing technologies to treat sickle cell anemia,

04:22a disease that has ravaged a lot of communities, primarily African Americans.

04:29This advancement is a crucial step towards treating sickle cell anemia and represents

04:33a breakthrough in gene therapy.

04:35FDA also secured additional supply chains in the wake of cancer drug shortages.

04:41It's crucial that FDA continue to carry out its mission and create meaningful regulations

04:46based on sound science and not conspiracy theories or ideological programs.

04:52Public attacks on FDA without any corresponding legislative solution simply undermine its

04:58ability to effectively protect public health.

05:03Antiabortion activists brought a case against FDA over its updated guidance on mifepristone,

05:07the first of a two-pill medication abortion.

05:10The activists claimed that FDA did not properly collect data on drug risks and complications.

05:16However, this claim is contrary to the FDA's review of, quote, extensive research showing

05:22that mifepristone is safe, including to take at home, unquote.

05:26FDA followed its standard procedure in reaching that conclusion, and according to the FDA,

05:31it must act reasonably based on the information available rather than act based on perfect

05:36data which seldom exists.

05:38If the objective of antiabortion activists is to undermine FDA's authority, the consequences

05:44will be devastating to public health.

05:45An FDA that bases its decisions on political science rather than actual science is not

05:51in the best interest of consumers.

05:53Congress must ensure that FDA is empowered to rely on the facts rather than bend to the

05:57will of people pushing an ideological agenda.

06:00Thank you, Mr. Chairman, and I yield back.

Raskin Advocates For FDA To Carry Out Mission Based ‘On Sound Science— Not Conspiracy Theories’

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