Inside HSCA: HSCA COMMENTS ON SENATE HELP COMMITTEE HEARING ON GENERIC DRUG ACCESS & PRICE SPIKES

The Senate Health, Education, Labor, and Pensions (HELP) Committee is scheduled to have a hearing today on “Generic Drug User Fee Amendments: Accelerating Patient Access to Generic Drugs.” HSCA President and CEO Todd Ebert, R.Ph., released the following statement on the hearing, access to critical generic drugs, and steps that Congress could take to help mitigate significant price spikes in the generic drug marketplace:

“We applaud the Senate HELP Committee for their commitment to mitigating price spikes in the generic drug market – a trend that poses enormous risk to public health by jeopardizing patient access to affordable healthcare. While the Generic Drug User Fee Act (GDUFA) was designed to speed public access to – and reduce costs of – generic drugs, since its implementation the FDA backlog for new generic drugs has grown, and some opportunistic suppliers have driven up their prices as a result of little-to-no competition. It is essential that new manufacturers are able to enter the market in a timely manner to help increase competition and reduce costs. We urge Congress to give FDA authority to expedite review and approval for new generic drugs that have the potential to mitigate price spikes and help ensure access to critical medications for healthcare providers and the patients they serve.”

The current backlog of Abbreviated New Drug Applications (ANDA) at the FDA is compounding the problem of price spikes. Since the Generic Drug User Fee Act was negotiated in FY2011, the FDA’s backlog has continually risen along with its median review time for product approval. A private sector survey revealed that prior to GDUFA, review time for ANDAs was 30 months. In FY2013, that time had risen to 36 months, and in FY2014 was estimated to be 42 months. A wait time of 3-4 years stifles the ability of some manufacturers who want to reintroduce competition to the generic market.

Ebert’s statement is the most recent effort in HSCA’s history of working with Congress to address and prevent generic drug price spikes. The organization previously sent letters to the Senate Special Committee on Aging and the Senate HELP Committee encouraging Congress to take specific action to help ensure a healthy generic market and safeguard patient and provider access to essential medications.