Provisions That Would Weaken FDA Oversight of Generic Medications Must Be Removed
Senators must oppose the Lower Health Care Costs Act (S. 1895) unless the legislation is amended to exclude sections 211 and 213, Public Citizen urged in a letter to members of the U.S. Senate today.
Section 211, regarding the “prompt approval of drugs related to safety information,” and section 213, regarding “modernizing the labeling of certain generic drugs,” would weaken existing requirements for ensuring that generic medications approved by the U.S. Food and Drug Administration (FDA) are safe and effective for their FDA-approved uses.
Section 211 would allow generic drug companies to omit certain safety information from the labels of certain generic medications, potentially endangering patients’ health. Section 213 would create two problems: First, it would lower the bar for FDA approval of new uses of certain generic medications by bypassing the existing more rigorous application process; and second, it would create a slow and cumbersome process for updating safety information on labels of certain generic products.
“We certainly appreciate the modest provisions in the legislation aimed at lowering drug prices and increasing transparency,” said Michael Carome, director of Public Citizen’s Health Research Group. “However, if lawmakers fail to amend the legislation to exclude sections 211 and 213, they will weaken FDA oversight of certain generic medications, putting consumer safety at risk.”
In addition, lawmakers should add a section that allows generic drug manufacturers to update their product labels with safety warnings when the manufacturers become aware of new risks. (Generic manufacturers now are not permitted to do this, even though brand-name manufacturers can.) This would ensure doctors and patients have the most up-to-date safety information about generic medications.
Read the letter here.