Here are five things to know.
1. The Orphan Drug Act, enacted in 1983, provides various incentives for drugmakers to develop treatments for patients with extremely rare diseases.
2. KHN in January released an investigative report showing many drug companies were using the Orphan Drug Act to “secure lucrative incentives and gain monopoly control of rare disease markets where drugs often command astronomical price tags,” according to the report.
3. The publication found more than 70 drugs with orphan status were not new and had already been approved by the Food and Drug Administration for mass market use, yet still qualified for a sales exclusivity period under the orphan drug status.
4. Sen. Grassley, chairman of the Senate Approbations Committee, cited KHN‘s report as his motivation for the inquiry, along with growing consumer concern over high drug costs.
5. On Feb. 3, Sen. Grassley said his staff is meeting with interested groups and other Senate staff to discuss the issue and how they might fix it, according to the report.
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