Statement by Chip Davis, President and CEO, GPhA, Regarding the State of the Union Address

Press Release

WASHINGTON, DC - “In the State of the Union address, President Barack Obama called for a major new initiative to identify a cure for cancer. GPhA applauds this administration’s efforts to fight cancer by funding the research that we all hope leads to a cure.

Innovation is needed to advance pharmaceutical science and get us closer to beating cancer once and for all. However, innovation cannot be truly impactful without access. Competition from generic drugs provides the government and other health stakeholders with the necessary headroom to invest in cancer research and related projects. A healthy pharmaceutical market, one that balances innovation and competition, is crucial to positive patient outcomes and generates the savings that makes these investments possible.

Generic oncology therapies saved the U.S. $7.5 billion in 2014 with cancer anti-nauseants generating another $11.6 billion in savings, according to the Generic Drug Savings in the U.S. report. To ensure these savings continue, Congress must avoid addressing outlier pricing actions taken by individual companies with sweeping policies that restrict patient access. Instead, policymakers should:

• Ensure a fully-resourced Food and Drug Administration (FDA) can address the backlog of more than 3,800 generic drug applications stalled while waiting for approval and shorten FDA median generic drug approval timelines, which, at the industry’s best estimate, currently stand at 48 months.

• Increase generic utilization among the low-income Medicare population, which could save up to $17.7 billion over 10 years.

• Pass the bipartisan FAST Generics Act to curb some brand drug company abuses of FDA safety programs such as Risk Evaluation and Mitigation Strategies (REMS) used to keep generics off the market, an estimated savings of $2.4 billion over 10 years.

• Work closely with industry and regulatory partners to ensure that the framework for biosimilars, safe and effective alternatives to costly brand biologic drugs, expands and expedites patient access. Estimated savings biosimilars savings range from $44 billion to $250 billion.

• Repeal Sec. 602 of the Bipartisan Budget Act of 2015. The Medicaid rebate increase for generic drugs in the budget deal is bad for Medicaid and its beneficiaries, bad for taxpayers, and it should be immediately repealed.

The association looks forward to continuing its work with the Administration, Congress, regulatory agencies and others to ensure that this industry’s remarkable record of patient access and patient savings can continue.”

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at gphaonline.org. Follow us on twitter: @gpha.