Sandip Shah, a visiting professor at Rutgers University, left, and President Joe Biden (D) | LinkedIn / WhiteHouse.gov
Sandip Shah, a visiting professor at Rutgers University, left, and President Joe Biden (D) | LinkedIn / WhiteHouse.gov
A provision of the “Inflation Reduction Act” (IRA) could threaten investments in "small molecule" drug development, said a visiting professor at Rutgers University.
There are currently up to 24 New York City biopharma companies involved in that type of drug development, according to Biopharmguy.com.
"Biologics are great for dealing with complex diseases, but small molecules will have a greater benefit to the US population in many years to come, because it's easy to produce many generics that will be available," Shah told the Somerset Times.
In addition to serving as a visiting professor at Rutgers University, Shah is president of Market Access Solutions, a Raritan, NJ-based consulting firm that works with pharmaceutical and biotech companies.
The IRA, signed into law by President Joe Biden (D) in 2022, contains a drug provision in which the brand-name drugs for which Medicare "negotiates" prices are split into two categories: small-molecule drugs and biologics.
The IRA makes small-molecule drugs eligible for "negotiation" nine years after their approval, compared to a 13-year exemption period for biologics.
Shah co-authored a March 29 op-ed in NorthJersey.com that said the IRA "penalizes research" on small molecule drugs and would have "painful consequences for patients."
He said a pending U.S. House bill, the "Ensuring Pathways for Innovative Cures (EPIC) Act" would equalize the exemption period for both biologic and small-molecule drugs. By granting both types of drugs a 13-year exemption, he said the bill would incentive innovation in small-molecule research.
“Make it both same and give the same incentives to both small-molecule factor as well as biologic small molecules,” said Shah.
Otherwise, he said, the IRA provision amounts to "price controls" that will curtail investment in small molecule drugs.
An October 2023 paper, authored by University of Chicago economists, said that the IRA small molecule provision will result in “188 fewer small molecule treatments, including 79 fewer new small molecule drugs and 109 fewer post-approval indications for these drugs.”
How many New York biopharma companies are involved in “small molecule” drug development?
Source: Biopharmguy.com
| Small Molecules that repair leaky Ryanodine Receptor calcium channels associated with human diseases |
| Small-molecule therapeutics to target molecular damage driving age-related disease |
Alerts Sign-up