Posted At US Newswire

BY : Tamara Lytle

The Seniors Coalition today released a letter to officials of the Food and Drug Administration (FDA), members of the Senate Health, Education, Labor and Pensions Committee, and members of the House Energy and Commerce Committee, in response to a blatant effort by the FDA impose a back-door tax on consumers by requiring generic drug manufacturers to finance their own approval process a requirement brought about by the FDAs own mismanagement.

Over the last 26 years, the Hatch-Waxman Act (passed by Congress in 1983) has afforded American patients with access to affordable generic medicines which prove to be safe and effective alternatives to brand name medications. This has been a welcome alternative for patients particularly senior citizens living on a severely restricted income while having to negotiate the ever-growing cost of prescription medications. These patients have, for more than two decades, depended upon the FDAs timely approval of generic drugs in order to access the significant savings at the pharmacy a process, however, that has stalled in recent years. The FDA has ignored the statutory requirement to review generic drug applications in a timely way, and has adopted a transparent strategy to force user fees on generic manufacturers even though such fees will have to be passed on directly to consumers.

Over the last several years, the FDA has allowed a backlog of more than 800 generic drug applications to pile up, while doing nothing to boost technologies or manpower required to ensure the timely review of low-cost prescription drugs, said Mary Martin, Chairman of The Seniors Coalition. In an effort to establish a quick-fix for the recent outcry against this mismanagement, the FDA is seeking to defer the cost of revamping and updating the resources for the OGD to the generic industry thereby forcing smaller generic manufactures out of business and increasing the cost of surviving generic drugs in the marketplace.

For 26 years, access to generic drugs has been a financial boon to patients and even to government healthcare programs alike, Martin continued. This new request signals a disturbing course change from what has been an unwavering commitment to consumers that has yielded billions in savings over the years.

When asked about the funding needs of the Office of Generic Drugs, FDA Officials have recently testified before Congress that the OGD did not need any additional funding and that there are no new plans to hire new reviewers in the coming fiscal year.

In its communications to the FDA and Congress, The Seniors Coalition has requested that an investment of $25 million be made to the OGD in the FY2007 budget to enhance the technology and manpower needed for efficient reviews an investment that will yield an immediate economic benefit. It is estimated that, in the first year alone, the proposed $25 million investment will yield savings many times the amount of the initial appropriations.

The FDAs allowing a buildup of a backlog of applications and their unwillingness to allocate necessary resources to the OGD, including the anemic concessions recently offered, indicates their blatant strategy to blackmail generic drug companies to accept user fees that would in turn devastate the financially fragile patients that have depended on the benefit of affordable medications for years, Martin said. It is our intention to ensure that the FDA and Congress have a realistic view of the state of the Office of Generic Drugs and allocate the necessary funding to ensure the update and better management of the generic drug approval process.