Washington, D.C. – Energy and Commerce Committee Republican Leader for the 116th Congress Greg Walden (R-OR), incoming Republican Leader for the 117th Congress Cathy McMorris Rodgers (R-WA), Health Subcommittee Republican Leader Dr. Michael Burgess (R-TX), and Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY) released the following statement after the U.S. Food and Drug Administration (FDA) announced its approval of a generic glucagon for injection. Glucagon is used to treat low blood sugar, or hypoglycemia, which often occurs in patients with diabetes.
“This announcement is a major step forward to ensure patients with low blood sugar have access to affordable treatment options, and we applaud FDA for their work to approve the first-ever generic glucagon for injection. We know that generics provide safe treatment alternatives that help more Americans afford their medicines, which is why the committee sent a letter to FDA earlier this year inquiring about the review process and lagging approval rates for complex generic medicines. Lowering what Americans pay for prescription medications – while protecting American innovation – will continue to be a priority for the House Energy and Commerce Committee, and we thank President Trump and his administration for their tireless commitment to this issue that affects millions of Americans,” said Walden, Rodgers, Burgess, and Guthrie.
In January, Energy and Commerce Committee leaders sent a letter to FDA requesting information about the approval process for complex generic drugs. You can read the letter HERE.
On May 15, 2020, HHS responded to the committee’s letter on behalf of the FDA. In the response, HHS reported that:
- From October 1, 2016 to January 17, 2020, FDA reported that it had approved 329 complex generic drugs.
- The FDA indicated that it does not have a formalized after-action or internal review process related to the review of complex generic drugs. However, the FDA had internal discussions to identify lessons learned from recent complex generic drug approvals, including challenges and areas for improvement. FDA provided an internal memorandum from an internal quality management group that outlined information and recommendations arising from the review and approval of the first generic version of the EpiPen. After the draft memorandum was generated, FDA realized it was necessary to look at a broader selection of complex generics, include feedback from reviewers involved in these reviews, and to generate recommendations to enhance review processes going forward.
- FDA had published 470 complex generic product-specific guidances (PSGs), two final and 468 draft, and had published 366 revisions of complex PSGs given evolving science.