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Bipartisan E&C Committee Leaders Request Info on Lagging Approvals for Complex Generic Drugs


01.17.20

WASHINGTON, DC – Bipartisan Energy and Commerce leaders sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn, M.D. to request information on the FDA’s process for approving complex generic drugs.

The letter was sent by Energy and Commerce Republican Leader Greg Walden (R-OR), Chairman Frank Pallone, Jr. (D-NJ), Health Subcommittee Republican Leader Michael Burgess M.D. (R-TX), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA), Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY), and Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO).

“We are interested in identifying ways to help reduce the costs of health care for patients, including the costs of prescription drugs. Generic versions of brand-name drugs provide substantial cost savings for patients and third-party payers and account for nine out of ten prescriptions filled in the U.S.,” the bipartisan Committee members wrote to FDA.

Generic alternatives to brand-name drugs are usually 75 to 90 percent cheaper. The Committee leaders acknowledge FDA’s efforts in approving a record number of generic drugs. However, the number of complex generic drugs is lagging. Complex drugs are important for patients with medical conditions such as multiple sclerosis, schizophrenia, metastatic breast cancer, osteoporosis, and chronic obstructive pulmonary disease (COPD).

“The length of time leading to the approval of some recently approved complex generics raises questions of whether additional actions may be necessary to encourage the development of these products,” the bipartisan Committee members continued.

The bipartisan Committee members requested FDA to provide the following information:

  • A list of all complex generic drugs approved by FDA since October 1, 2016, including the date of the first submission, the dates of other milestones (e.g., issuance of complete response letters [CRLs], subsequent submissions), and the date of approval.
  • Copies of any after-action reports or internal reviews related to the review process of complex generic drugs approved since October 1, 2016.
  • The number of pre-Abbreviated New Drug Application (ANDA) meeting requests that FDA has received each year since the program was launched, the number of pre-ANDA meetings that FDA has held each year, and the number of ANDAs that have been submitted for products discussed during these meetings.
  • The number of product development meeting requests for complex products, as defined in the GDUFA II commitment letter, that FDA has received each year since August 1, 2017; the number of product development meeting requests for complex products that FDA has held each year; and the number of ANDAs that have been submitted for products discussed during these meetings.
  • A list of product-specific guidances FDA has published for complex drug products, including the number of such guidances that are draft and the number of such guidances that are final.

CLICK HERE to read the letter to FDA.

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