In an interview last week, the FDAs Scott Gottlieb said the Orphan Drug Act of 1983 has provided an enormous amount of public health value over the years, but the market has changed.

The nations most influential science advisory group will tell Congress today that the U.S. pharmaceutical market is not sustainable and needs to change.

Earlier this month, House Republicans proposed eliminating the orphan drug tax credits, one of many financial incentives for drugmakers intended to spur development of medicines for rare diseases.

The American Hospital Association, the Association of American Medical Colleges, Americas Essential Hospitals and others filed suit on Nov. 13,over the Centers for Medicare & Medicaid Services' decision to slash funding for the program by 28 percent.

Federal officials are exploring how beneficiaries could get a share of certain behind-the-scenes fees and discounts negotiated by insurers and pharmacy benefit managers, or PBMs, who together administer Medicares Part D drug program.