Rep. Earl L. “Buddy” Carter (R-GA) introduced legislation that will speed up the FDA’s approval process for affordable alternatives to brand name drugs.
The Enhanced Access to Affordable Medicines Act of 2022 will save the health care system millions and increase access to generic medications.
“We need to cut the red tape that delays patient access to life-saving medications. This bill could shorten the approval process for generic drugs by as much as three months, which translates to savings for patients, drug manufacturers, and the health care system,” said Carter.
Generic drug labeling is required to be the same as the referenced brand product for a drug application (ANDA) to be approved. When the labeling for the brand product is changed during the approval process, approval of the generic will be delayed until the applicant amends its ANDA with updated labeling and the FDA reviews the labeling amendment.
“With this bill, we have the opportunity to restore some efficiency and integrity in the drug manufacturing system,” said Carter.
Read the full text of the bill here.
Original source can be found here.
