Generic Supply Chain

A virtuous cycle of innovation and access has served as the foundation for our nation’s prescription drug market since the presidency of Ronald Reagan. When that market worked as Congress originally intended around the time of enactment of the Hatch-Waxman amendments in the 1980s, patients benefited from lifesaving new drugs; they maintained their health with generic medicines; brand drug makers recouped their investments, rewarded shareholders and were incentivized to discover new therapies and cures; and the makers of generics had thriving businesses.

The Hatch-Waxman Act, signed into law by President Ronald Reagan in 1984, created a pathway for patient access to affordable medicines, balancing competition in the pharmaceutical sector with innovation and giving rise to the generic drug industry as we know it.

AAM President and CEO Chip Davis testified before the U.S. House of Representatives Energy and Commerce Health Subcommittee December 13 at its hearing, “Examining the Drug Supply Chain.” The oldest standing legislative committee in the U.S. House of Representatives, this body is vested with the broadest jurisdiction of any congressional authorizing committee.

Dr. Scott Gottlieb, Commissioner of Food and Drugs, has adopted a bold stance on behalf of patient access to affordable medicines. In particular, he is targeting REMS abuse — by which some bad actors prevent generic firms from purchasing the doses of a branded drug that they need to run their studies — for the way it undermines the sustainable competition necessary for FDA-approved generic drugs and biosimilars to reach patients.