NCHR Supports FDA’s Guidance on Generic Drug Labeling Safety

National Center for Health Research, September 9, 2016

Division of Dockets Management
Food and Drug Administration
Department of Health and Human Services
5630 Fishers Lane, Room 1061
Rockville, MD 20852

 

Comments of members of the National Center for Health Research
on the draft guidance
Updating Abbreviated New Drug Application Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn
[Docket No. FDA-2016-D-1673]

The National Center for Health Research, and its Cancer Prevention and Treatment Fund, generally support the draft guidance “Updating Abbreviated New Drug Application Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn.”  It is a small step in the right direction to address generic drug labeling safety issues.

Generic drug makers are expected “to update their labeling” after the Agency has approved changes to the labeling for the brand name drug (RLD or Reference Listed Drug).[1] However, when the brand name drug is no longer sold (withdrawn from the market), we strongly agree that the labeling of the generic drug might become “inaccurate and outdated, resulting in labeling that is false and/or misleading.”[1]

The draft guidance describes a process for updating labeling for generic drug applications in cases where “FDA has withdrawn approval of the new drug application (NDA) for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness.”[1] A major problem with the draft guidance is that it is limited to situations where the RLD has been withdrawn. A better way for the FDA to ensure all generic manufacturers update their labels when necessary is for the Agency to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products.”

Finalizing the proposed rule would allow generic drug makers to quickly make safety updates to their labels through changes being effected (CBE).  Through the Patient, Consumer, and Public Health Coalition, we submitted comments in support of the proposed rule in 2014 because it would give patients access to the most up-to-date product labeling information regardless of whether they choose a brand-name or generic drug.[2]  It is not acceptable that two years later the FDA has not yet finalized the proposed rule.  The proposed rule is more robust and would better safeguard the health and safety of patients and consumers because it would require safety changes, whereas the draft guidance is not binding.  Also, due to the lack of access to the CBE process, generic drug makers currently are not responsible for injuries or deaths caused by their products, and consumers are left without judicial recourse.

We cannot emphasize enough how important it is to quickly update safety and efficacy information on generic drug labels, since nearly 80 percent of prescriptions filled in the U.S. are for generic drugs.[3] Also, once generic drugs dominate the market, the brand name drug often leaves the market, and since generic drug makers cannot currently use the CBE process, the generic drug labels may not list safety problems, and that unnecessarily puts patients at-risk.

Conclusion

Millions of Americans rely on generic drugs to provide the same benefits as brand-name drugs, and they deserve up-to-date information about the prescription drugs that they use. It is essential that all prescription drugs (not just brand named drugs) carry accurate safety warnings and all manufacturers remain attentive to potential health hazards.

We support this draft guidance, which is a step in the right direction for protecting the public health.  However, the guidance should be broadened to include all situations, regardless of whether the RLD has been withdrawn.  Moreover, to truly ensure that generic drug labels are updated in a timely manner, the FDA needs to finalize the proposed rule, “Supplemental Applications Proposing Labeling Changes For Approved Drugs and Biological Products.”

  1. Food and Drug Administration (2016). Draft Guidance, “Updating Abbreviated New Drug Application Labeling After the Marketing Application for Reference Listed Drug Has Been Withdrawn,” Docket No. FDA-2016-D-1673.
  2. Comments of Members of the Patient, Consumer, Public Health Coalition (February 10, 2014). Proposed Rule,“Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,”Docket No. FDA-2013-N-0500 
  3. Food and Drug Administration. “Facts About Generic Drugs”webpage.