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Statement by Chip Davis, President and CEO, Generic Pharmaceutical Association, Regarding the Senate Aging Committee Hearing on Off-Patent Drugs

Contact: Steve Arnoff 202.249.7113 

WASHINGTON, DC (Dec. 9, 2015) — “The Generic Pharmaceutical Association (GPhA) commends the Senate Aging Committee for recognizing that competition from generic drugs continues to hold down health costs for American patients. In fact, generic drugs are 88% of prescriptions but only 28% of pharmaceutical costs, according to the 2015 Generic Drug Savings in the U.S. report. Policies that promote generic competition help ensure patient access to these safe, effective and affordable medicines. However, several suggestions floated today could compromise patient safety if adopted.

For example, encouraging mass compounding of drugs creates avoidable safety risk to patients from medicines that are not Food and Drug Administration (FDA) approved. Also, importing foreign drugs that circumvent existing FDA safety, efficacy or quality standards undermines existing supply chain controls and compromises patient safety.

Congress must avoid addressing outlier pricing actions taken by individual companies with sweeping policies that restrict patient access or invite other unintended consequences. Instead, policymakers should support competition by embracing policies that:

• 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.

GPhA will continue to drive a constructive dialogue on increasing generic competition to lower health costs while working with Congress, FDA and others to prioritize patient access, savings and safety.”

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.