Regulatory Focus™ > News Articles > Legislators, Public Citizen Urge FDA to Close Safety Update Loophole for Generic Drugs

Legislators, Public Citizen Urge FDA to Close Safety Update Loophole for Generic Drugs

Posted 26 June 2013 | By Alexander Gaffney, RAC

Several groups are calling on the US Food and Drug Administration (FDA) to issue new regulations to permit generic pharmaceutical companies to alert consumers to potential safety problems, a practice now prohibited and the focus of several recent high-profile legal cases.


On 24 June 2013, the US Supreme Court issued a ruling in the closely-watched case of Mutual Pharmaceuticals v. Bartlett, finding that generic companies were not liable for injuries suffered by patients when a generic product's label did not include a warning regarding a known issue.

[For more on Mutual v. Bartlett, please see our extensive explanation here.]

At the crux of the issue is the approval process for generic drugs, which occurs under the abbreviated new drug application (ANDA) process. To obtain approval, generic companies must show their drugs are equivalent to a reference drug that has already obtained FDA approval through the new drug application (NDA) process. If successful, the generic drug's labeling must exactly match up with the reference drug's labeling with respect to a particular claim.

However, only the holder of the NDA may update a product's label, which is done either through a prior approval supplement (PAS) for major amendments or a changes being effected (CBE) notification to strengthen the safety labeling to include new risks.

This gap creates two potential issues for the purposes of the safety of generic drugs:

  • Safety issues may emerge after the emergence of the generic drug onto the market, and the NDA holder would not be obligated to update its safety labeling unless ordered to by FDA.
  • If a product has been on the market for an extensive period of time, the holder of the NDA may no longer be in business, leaving the NDA to stagnate even as it continues to act as a reference for approved and marketed generic drugs.

In the case of Bartlett, this left the generic company, Mutual, in something of a bind: It was aware of an extremely rare safety issue, but was unable to update the safety labeling for the product.

Public Citizen Report

Faced with the second adverse ruling since the 2011 (the other being Pliva v. Mensing, a nearly identical case), some groups and legislators are now gearing up to attempt to close the loophole.

In a report issued shortly after the release of the Bartlett decision, Public Citizen, a consumer advocacy group, said its data showed a substantial need for a mechanism for updating generic drug safety labeling.

For example, the group looked at the number of serious safety issues only found after the entry of a generic competitor. "Reviewing the period January 2008 to March 2013, we identified 53 drugs for which a black-box warning calling attention to serious or life-threatening risks was added after generic market entry," it wrote, adding that "the list is likely incomplete." Black box warnings refer to the most serious risks associated with a product, and the list leaves out a huge number of other less serious risks.

In addition, and to the second point identified earlier, Public Citizen's report calls attention to the inability for even the leading generic manufacturer to update an NDA if the brand-name manufacturer ceases production. "[No] manufacturer is responsible for ensuring the adequacy of labeling for these drugs," Public Citizen noted.

The present system of regulation has created a "safety and accountability gap," Public Citizen continued. "Too often, a serious safety hazard is not identified until years after a prescription drug comes on the market, and many prescription drugs today are marketed only in generic form. For these reasons, the FDA's restriction on labeling revisions by generic drug manufacturers creates a gap that threatens patient health and safety."

The group stopped short of issuing specific recommendations on how the gap might be closed.

Congress Steps In

Legislators, too, are pressing FDA to make changes.

In a 24 June 2013 letter to FDA Commissioner Margaret Hamburg, Reps. Chris Van Hollen, Bruce Baley, Henry Waxman and Matt Cartwright and Sens. Patrick Leahy, Tom Harkin and Al Franken - all Democrats - said current regulations "raise serious concerns about patient safety and accountability for manufacturers."

Noting that nearly 80% of all prescriptions filled are for generic pharmaceuticals, the group urged FDA to "revise this position and amend its labeling regulations so that generic manufacturers may participate fully in the labeling process, using a process akin to the CBE process that is available to brands."

The letter goes on to note that legislation that would have required FDA to do the same was introduced in April 2012, shortly after the Mensing decision, but it did not pass. However, the group said they had noticed in the Bartlett briefs filed by FDA that it was considering issuing a regulation to close the safety update loophole, but were concerned that FDA had not yet taken any apparent action to advance this regulation.

Congressional Letter to FDA (2)

Public Citizen Report

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