BIO Defends Orphan Drug Incentives Against Critics

The biotechnology trade group responded to a Health Affairs analysis arguing that IRA protections for orphan drugs are unnecessary.

Updated on Nov. 5, 2026 in Healthcare

BIO Defends Orphan Drug Incentives Against Critics

Live Poll

Should drugs for rare diseases be exempt from government price controls?

BIO published a rebuttal in Health Affairs from Vice President of Healthcare Policy & Research Crystal Kuntz, responding to an analysis that suggested Inflation Reduction Act protections for orphan drugs are not needed. The group argues orphan drugs face unique scientific, developmental, and commercial challenges.

Why it matters

The debate centers on whether exemptions from government price controls for orphan drugs remain warranted for treatments aimed at rare diseases. BIO contends that thousands of rare diseases still lack a treatment, making the incentives a continuing policy question for U.S. lawmakers.

BIO's rebuttal, published in Health Affairs, states that thousands of rare diseases still lack a treatment despite congressional orphan drug incentives. The extraction does not provide specific revenue or program figures to quantify the debate.

The players

Biotechnology Innovation Organization (BIO)

The trade association representing biotechnology companies, which advocates for drug development policy in the United States.

Crystal Kuntz

BIO's Vice President of Healthcare Policy & Research, who authored the rebuttal published in Health Affairs.

The details

Congress has provided incentives for orphan drug development, including exemptions from government price controls under the Inflation Reduction Act. A Health Affairs article argued those IRA-related protections are not needed, prompting BIO's rebuttal authored by Crystal Kuntz, which describes a "golden age" in orphan drug development.

Earlier in the article's timeframe: a Health Affairs article suggested IRA protections for orphan drugs were unnecessary.
This month, November 2026: Health Affairs published BIO's rebuttal.

Market Landscape

The rebuttal defends the orphan drug exemptions created under the Inflation Reduction Act's government price control provisions. It positions biotechnology industry advocates against analysts who argue the rare-disease carve-outs are no longer needed.

The outcome of this debate could determine whether certain rare-disease medications remain exempt from government price controls. Patients with rare conditions and the families who depend on those treatments would be most directly affected by any change.

The takeaway

Policy choices about orphan drug incentives balance the cost of rare-disease treatment against the development risks drugmakers face. Readers following drug pricing should watch how lawmakers weigh those competing considerations.