Two Washington lawmakers want the Federal Trade Commission to examine whether so-called pay-to-delay deals are preventing biosimilars from reaching Americans sooner than the drugs would otherwise and, consequently, are increasing costs for the health care system.
In a letter to the FTC, Sen. Amy Klobuchar (D-Minn.) and Sen. Chuck Grassley (R-Iowa) argued there is reason for concern that the same controversial tactic used to thwart the arrival of lower-cost generics is being extended to biosimilars.
These drugs are nearly identical variants of pricey, brand-name biologic medicines, but are expected to cost less while providing the same result in patients. And the savings could be substantial. Biosimilars are forecast to save the U.S. between $27 billion and $58 billion in health care costs by 2021, according to IQVIA Institute for Human Data Science, the market research arm of IQVIA.
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Is there an issue here or not? Is there even a story? The headline screams about harmful “pay-to-delay” deals, and then dredges up a single example that isn’t an example at all, if the statements from AbbVie and Amgen are to be believed. So the issue is really about government thinking it has the right to interfere in normal day-to-day business because it concerns health care? Lines drawn are often murky and shift as administrations come and go. So when is it acceptable for “lawmakers” to screw with businesses making deals, which is how this world turns, folks. That’s the story. Or am I missing something?
Hi Rod,
Thanks for writing in. First, only two examples were cited because that was what the lawmakers noted in their letter to the FTC, although the settlements were rather prominent, given these involved such a huge-selling drug for which AbbVie has created a patent thicket.
Beyond that, you raise a fair point about government interference, assuming there is nothing more to the agreements than what AbbVie says.
But I’ll play devil’s advocate and suggest that we shouldn’t take the company’s word at face value and, instead, have a look at the agreements, in the event some other consideration was involved. If not, then so be it.
But as Carrier noted, we don’t really know all the details. And many of these negotiated patent settlements were problematic enough for the Supreme Court to encourage the FTC to continue its scrutiny.
Feel free to keep the conversation going.
ed at pharmalot