WASHINGTON – In his new capacity as Chairman of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee, Congressman Bart Stupak (D-Menominee) is opening an investigation into the generic drug approval process at the Food and Drug Administration (FDA).  Stupak wrote FDA Commissioner Andrew von Eschenbach regarding how quickly the FDA approves generic biopharmaceutical drugs. 

“The Subcommittee intends to monitor the progress of FDA in ensuring that American consumers enjoy the benefits of affordable drugs,” Stupak’s letter states. 

The letter requests that the FDA provide the Subcommittee with a list of FDA-approved drugs that are expected to have their patents expire during 2007.  The letter also asks that the FDA provide a list of its backlog of generic drug applications.  The letter also requests an accounting of FDA funds that are used to review generic drugs and how many full-time employees work at the FDA’s Office of Generic Drugs, the division responsible for overseeing the generic drug approval process. 

“Generic drugs are critical to making prescription drugs more affordable for Americans,” Stupak added.  “It is important that the Subcommittee obtain a thorough understanding of how the generic drug approval process is or is not working at the FDA.  If the FDA’s process is not working, then Congress may need to act to speed up the approval of generic prescription drugs.  This letter is the first step to gauge the extent of any problems in the generic approval process.”

Stupak’s letter goes on to request that the FDA provide the Subcommittee with an opinion as to whether the agency believes it has the necessary legal authority to accept and approve applications for biopharmaceutical drugs.

“Please state whether you believe your existing authority is sufficient to accept and approve abbreviated applications for biopharmaceutical drugs,” Stupak’s letter continues.  “If not, please provide us with a copy of any draft legislation that you believe is required to facilitate the timely approval of these drugs that are critical to achieving affordable, quality health care in this country.”

The letter gives the FDA until February 15^th to respond.  The letter is co-signed by Rep. John Dingell (D-MI), the Chairman of the full, House Energy and Commerce Committee, which has jurisdiction over health issues and the FDA.  The term generic biopharmaceuticals is used to describe those drug treatments, which are generally large protein molecules derived from living cells. Examples include insulin, antibiotics, and monoclonal antibodies.

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NOTE: the text of Stupak’s letter is below.

January 29, 2007

The Honorable Andrew C. von Eschenbach, M.D.

Commissioner

Food and Drug Administration

5600 Fishers Lane

Rockville, Maryland  20857-0001

Dear Dr. von Eschenbach:

            Pursuant to Rules X and XI of the Rules of the United States House of Representatives, the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce is conducting an inquiry regarding the adequacy of the generic drug approval process at the Food and Drug Administration (FDA).  Among the issues of particular interest in this inquiry is the failure of FDA to use its existing authority to approve generic biopharmaceutical drugs under Sections 505 (b)(2) or 505 (j) of the Food Drug and Cosmetic Act (FDCA); Section 351of the Public Health Service Act (PHSA); or elsewhere.  Another issue of importance to the Subcommittee is the adequacy of resources devoted to the Office of Generic Drugs (OGD). 

            The Subcommittee intends to monitor the progress of FDA in ensuring that American consumers enjoy the benefits of affordable drugs.  To that end we request that you provide the Subcommittee with a list of FDA-approved drugs scheduled to go off patent or otherwise lose exclusivity during calendar year 2007.  We further ask that you provide, for each year from 2002 through 2006, an accounting of the backlog of applications within the generic drug approval process, the funds expended in the review process, and number of full-time equivalent employees (FTEs) within the OGD. 

            In addition, please provide the Subcommittee with a list of biopharmaceutical drugs (also referred to as follow-on biologic drugs) for which the FDA has received abbreviated applications under Section 505 the FDCA or Section 351 of the PHSA.  The list should include the name of the drug and the date that the initial application for abbreviated approval was received by FDA.

            Lastly, please state whether you believe your existing authority is sufficient to accept and approve abbreviated applications for biopharmaceutical drugs.  If not, please provide us with a copy of any draft legislation that you believe is required to facilitate the timely approval of these drugs that are critical to achieving affordable, quality health care in this country. 

            We ask that the information requested in this letter be sent to the Committee by no later than Thursday, February 15, 2007.  Should you have any questions regarding this request, please contact the Committee staff at (202) 225-2927.

Sincerely,

____________________________________            ___________________________________

John D. Dingell                                                             Bart Stupak

Chairman                                                                      Chairman

Committee on Energy and Commerce                            Subcommittee on Oversight and Investigations

                                                                                    Committee on Energy and Commerce