Rare Disease Drugs Turning Huge Profits Catch Congress’ Eye

Drug companies developing medications for extremely rare diseases could lose their longer exclusivity period if they later turn a profit under changes to the drug approval process Congress is set to debate.

Congress has been debating ways to lower drug and health-care costs for years, and changes to the Orphan Drug Act are next on the list. To that end, the House Energy and Commerce Health Subcommittee will debate the Fairness in Orphan Drug Exclusivity Act Wednesday.

The bill would change the way research and development costs are calculated to stop potentially profitable drugs from getting the extra exclusivity and ...