Today, FDA Acting Commissioner Ned Sharpless opened a day-long public hearing on its just-released proposed rules for biosimilar and interchangeable insulins. As the meeting began, the FDA released an opening statement from the acting-commissioner.
The comments seem to indicate that Acting Commissioner Sharpless intends to continue to strike the same critical tone towards insulin makers struck by the previous FDA commissioner, Scott Gottlieb, who left the post in April 2019. In a speech in front of representatives from the major insulin manufacturers, Dr. Sharpless accuses those manufacturers of leveling “intolerable” price increases for a live-saving drug.
You can ready key passages from Acting Commissioner Sharpless’ opening remarks below:
The acting commissioner discusses his experience treating people with diabetes in diabetic ketoacidosis (DKA) to put the importance of insulin in context:
“As an internist, I can recall almost no condition more satisfying to treat than diabetic ketoacidosis. These patients would come in so sick, so near death, and we’d give them 10-20 units of good old regular (porcine or bovine) insulin, and these patients would, within hours, rise like Lazarus. And then they’d tell you they feel better, and often immediately want to go home. If that does not make you feel like a real doctor, nothing will.”
He says that the release of three follow-on insulins since 2015 has done little to bring about downward pressure on insulin prices. He then said that such price increases force patients to make terrible choices:
“It hardly needs to be said that these kinds of whopping and steady price increases make it increasingly difficult for many insulin-dependent patients to afford the basic medicines they need to survive. As a physician, I find this intolerable: no patient should have to choose between paying for their medicine and paying for their rent.”
He describes the FDA’s history of regulating insulin and how it will change under the new rules:
“This is a little complex, but let me try to explain. While insulin products are proteins (or biologics), they historically have been regulated under the FD&C (Food Drug and Cosmetic Act), which governs the approval of drugs and generics, rather than the PHS (Public Health Service Act), which governs the approval of most biologics.
By moving insulin and other applicable products to be under the PHS, Congress has promoted a pathway for follow-on insulin products to become available. So this means that insulin and insulin analogs will now be open to biosimilar competition, which in turn can lead to development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness.”
He says the proposed rules will go in effect in March 2020, and he wants to hear from stakeholders for guidance:
“We want to hear from you about what factors we should consider in evaluating information submitted by applicants for new biosimilar products.
(First,) what scientific standards should we use for evaluating, within the bounds set by the statutory requirements, whether an insulin product is biosimilar or interchangeable to a reference product?
(Second), do certain products, like insulin pumps for continuous subcutaneous infusion raise unique scientific considerations that we should be considering when evaluating biosimilar or interchangeable insulin products?
(Third), we want to know what aspects of the patient experience with insulin products should FDA consider when making this evaluation?
(Fourth), what kinds of information and resources do we need to develop to foster effective communications and promote awareness among patients, clinicians, pharmacists, and other stakeholders about biosimilar and interchangeable insulin products?”
You can read the full statement here.
You can read the proposed regulations here.
You can submit comments on the proposed regulations here.
Text in parentheses was added for clarity for the quoted passages.
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