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.
In his testimony, Chip emphasized that the sustainability of a competitive generic market and the availability of generic medicines for patients, uninterrupted by shortages, is in jeopardy. In 1984, Congress enacted the Hatch-Waxman Act which represents a model of successful, bipartisan public policy. Over its more than 30-year history, the Act has produced a thriving and constantly-changing marketplace by balancing innovation in drug development and accelerating the availability of lower cost generic alternatives. This has important effects on public health, allowing patients to live longer, healthier lives. This balance is now threatened by three factors:
- changing and increasingly challenging market and reimbursement frameworks;
- the abuse of laws and regulations by bad actors; and,
- a failure of policy to account for the unique challenges facing generic and biosimilar medicines.
- Repeal the misguided Medicaid penalty on generic drugs;
- Pass the bipartisan CREATES Act and the FAST Generics Act to ensure generic and biosimilar manufacturers’ access to samples; and
- Include biosimilars in the coverage gap discount program in Medicare Part D.