BOSTON – Senator John Kerry today urged the Food and Drug Administration (FDA) to explain the long delays in getting new generic prescription drugs out on the market.

People across Massachusetts and throughout the nation are facing rising costs for medications they depend on every day. For some, especially the elderly and low-income families, affordable generic drugs can be the difference between life and death.

The FDA is currently required to review a generic drug application within 180 days. However, the median approval time for a generic drug application now takes longer than 21 months - well beyond the 180 day requirement. These delays create a serious backlog of applications.

Congress has taken several positive steps to help alleviate this backlog, including providing an additional $6 million in federal funding to the FDA’s Office of Generic Drugs.

“We’ve got senior citizens and low income working families who have to choose between filling their gas tank or filling their prescriptions. That’s wrong, and it’s unnecessary if the FDA would do more to get safe, affordable generics approved for the marketplace. Congress alone cannot fix the problem. The FDA needs to act now to ensure that no one has to go without medication because affordable generic versions are caught up in unnecessary bureaucratic delay,” said Senator Kerry.

The text of the letter is as follows:

June 17, 2008

The Honorable Andrew C. von Eschenbach, M.D.
Commissioner, U.S. Food and Drug Administration
5600 Fishers Lane; Parklawn Building 14-71
Rockville, Maryland 20857

Dear Commissioner von Eschenbach:

Rising prescription drug costs are a serious burden on the people of Massachusetts and across America. When patients are forced to take fewer of the medicines they need to make their prescriptions last longer, I believe we have a serious problem. That is why we must ensure that consumers have access to safe, effective and affordable generic medicines. It is critical that the Food and Drug Administration (FDA) work to provide timely review of generic drug applications.

It is my understanding that FDA is statutorily required to review a generic drug application within 180 days. However, this requirement is consistently not met by FDA. It is also my understanding that the median approval time for a generic drug application has steadily increased over the past three fiscal years, reaching 21.6 months earlier this year. These trends are worrisome given the importance of generic medicines for patients.

Congress has taken several positive steps to help alleviate this backlog. We provided FDA’s Office of Generic Drugs (OGD) an increase of $6 million in FY08. While I am aware that increased resources alone will not eliminate some of the longstanding barriers to consumer access to generics, they should help reduce the median time to some degree.

I am sure you will agree that Congress cannot fix the problem by itself. FDA needs to take action as well. To ensure that we have all the facts at hand, I am requesting the following information:

• How much of the appropriated Agency’s budget is allocated to the “Office of Generic Drugs” versus the “OGD program”? We understand that a certain portion of the OGD budget is used to support programs that are ancillary to OGD’s direct review responsibilities of reviewing and approving abbreviated new drug applications (ANDAs).
• What is the current median approval time for a generic drug application?
• What is the number of generic drug applications currently pending before FDA? Please breakdown the number of applications by those currently in the 180 day window, those pending beyond the 180 days, and those beyond the 2005-2006 median approval time for applications.
• For those applications pending more than 180 days, what internal steps/improvements is the Agency currently taking to help reduce the backlog and expedite approval of affordable generic medicines? What, if anything, is being done to improve the response time for consultations to divisions outside of OGD?
• Is the FDA considering any longer-term proposals to address the backlog of applications? If so, please explain in detail the plans. If not, please explain why FDA is not taking any action.
• What steps has FDA taken to implement Section 914 of H.R. 3580, the Food and Drug Administration Amendments Act? What is the timeframe for completing implementation?

Thank you for your attention this matter and I look forward to your prompt response.

Sincerely,

John Kerry