Lots of angst between the FEDA and Pharma over drug pricing controls and price negotiations.
There will be lobbying a’plenty by Pharma to mitigate what is already enacted and stem the tide of further price incursions. The article below offers a scientifically based premise that there is a major flaw in the current pricing rules.
What is noteworthy is that the premise is based on the simple distinction of small vs. large molecule drugs. As noted, the recently enacted Inflation Reduction Act draws a distinction between large and small molecule medicines setting price control provisions to kick in for small molecule medicines after 9 years (following FDA approval) vs. 13 years for large molecule biologics.
Fowl most cruel crieth Pharma!
Why the angst?
The developers say that they will lose the incentive to invest in post-approval R&D and patients will lose access to potential new treatments. It is here that the FEDS will start to push back saying that post approval R&D is not that costly….. especially if the original approval was for an orphan condition (that incidence is very high) which garnered valuable marketing benefits such as extended exclusivity. The FEDS will also likely push pack on the argument offered below that the developers will likely tend towards large molecule formulae because of the longer 13-year exemption from price controls.
The accountants can do the cost analyses but there is a good likelihood that a small molecule candidate with a shorter price exemption period will generate more $$s because “patients prefer small molecule medicines that usually come in the form of pills over biologic injections or infusions by a wide margin.” And….. small molecule drugs “are generally easier to make at scale and nearly always less expensive for patients. Importantly, small molecule medicines are more easily genericized than biologics, leading to greater adoption and lower costs.”
So…. On which side of the argument do you lean?
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The IRA’s nonsensical distinction between small- and large-molecule drugs
Thanks to advances in science, notably the completion of the Human Genome Project 20 years ago, we are able to treat diseases more effectively than ever before. Researchers have more sophisticated tools not only to identify new drug targets, but also to make drugs to hit those targets. A wide variety of therapeutic agents help make these drugs, including chemically synthesized small molecules; larger molecules made of amino acids like peptides, proteins, and antibodies; and nucleic acids like RNA or DNA. Choosing among these approaches requires looking at the target attributes. Is it inside the cell or outside? Is the target an enzyme, a gene, or a lipid particle? Do we need to block the target or stimulate it? Science is — and should be — the guide to determine the optimal approach for patients.
That’s why, to researchers like me, a provision in the recently enacted Inflation Reduction Act is puzzling. For no clear reason, it draws a distinction between large and small molecule medicines. …………….. continues
