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Letter to Food and Drug Administration Commissioner Margaret Hamburg

Letter

By:
Date:
Location: Washington, DC

U.S. Sen. David Vitter last week sent a bipartisan letter to Food and Drug Administration Commissioner Margaret Hamburg urging her to prioritize the generic drug approval process by elevating the Office of Generic Drugs so it reports directly to the Director of the Center for Drug Evaluation and Research.

The letter, also signed by Sen. Jeanne Shaheen, cites the current backlog of generic drugs awaiting FDA approval and the significant cost savings generic drugs have provided for the government and American consumers.

The full text of the letter is below.

June 23, 2010

The Honorable Margaret A. Hamburg, M.D.
Commissioner, Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Dear Commissioner Hamburg:

We write to urge the FDA to take decisive action to prioritize the generic drug program so that Americans can have better access to affordable medicines.

As Commissioner, you have the authority to implement real reform by prioritizing generic drugs and elevating the Office of Generic Drugs (OGD) so it reports directly to the Director of the Center for Drug Evaluation and Research. Throughout its history, the FDA has reorganized several times and as recently as last year. Section 301 of Title 5 in the U.S. Code gives you the administrative authority to organize and manage the department. In addition, OGD should have direct representation in the Office of the Commissioner to provide it with the highest degree of oversight and coordination as possible. Therefore, we urge you to use the authority you have to reorganize the agency to send a clear message that generic drugs are an important priority at the FDA.

Despite a 60 percent increase in generic drug use by the American public over the past 15 years and a four-fold increase in the number of generic drug applications handled by the FDA's Office of Generic Drugs each year, there has been no significant reorganization of the OGD since 1994. The approval process for generic drugs takes far too long, with over 2,000 unapproved applications in the queue. The OGD cannot keep up with the unprecedented increase in generic applications and, by your own admission, the increase in volume has outpaced your ability to review applications properly and in a timely fashion. Because the OGD is buried deep in the bureaucracy of the FDA, it is afforded limited resources and administrative autonomy and authority.

Generic drugs have long offered a safe and inexpensive alternative to many brand-name drugs. Analysis done by the FDA found that, on average, the cost of a generic drug is 80 to 85 percent lower than the brand name product. This significant price differential, combined with the growing national prominence of generic drugs, has saved the consumer and the government upwards of $750 billion over the last decade. We want to ensure that Americans have access to affordable drugs and believe that an enhanced reporting structure and oversight of the Office of Generic Drugs are critical in that effort.

We want to work with you on this issue. We are considering legislation to streamline the generic drug approval process by elevating OGD so that affordable prescription drugs are more readily available to Americans, but recognize that you have the authority to elevate OGD without legislation. To that end, we would appreciate it if you could provide us with answers to the following questions: 1) Are you willing to administratively elevate the Office of Generic Drugs? 2) Are you willing to create a position within the Office of the Commissioner to advocate and coordinate the activities of the Office of Generic Drugs?

We appreciate your attention to this matter and your commitment to ensuring that Americans can have better access to affordable medications. We look forward to working with you on this important issue.

Sincerely,

Jeanne Shaheen
David Vitter


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