We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws.  We have been remiss, however, in not mentioning the industry’s 2014 counter-proposal that’s was jointly proposed by GPhA (for the generic industry) and PhRMA (for the branded/innovator drug manufacturers).  Given how intensely the generic and branded wings of the pharmaceutical industry compete with (and sue) one another, that they could join together in opposition to the FDA’s proposal says something in and of itself – like how bad the FDA’s proposal really is.

Anyway, to start, here is a link to the joint GPhA/PhARMA letter that details the industry’s solution to the problem of label-update delay in general.  That’s the key.  The industry proposal ends the disparity (identified by the Supreme Court in Mensing, among other places) between how the FDA treats generic and branded/innovator drugs.  The industry proposal thus stands in stark contrast to the FDA’s, which would both perpetuate and worsen the divergence between the processes affecting the two types of prescription drug manufacturers.

The industry fix is called “Expedited Agency Review” – or “EAR” for short.  Unlike the FDA’s pending proposal, the revisions advanced by industry ensure that label change procedures won’t run afoul of the “sameness” requirement that’s built into the statute (the Hatch-Waxman part of the FDCA) itself (a problem we discussed here).  Thus, it could take effect without lengthy litigation.  It also makes the FDA work harder, something that the Agency doubtlessly doesn’t care to do.

As detailed in the “Alternative to the Proposed Rule on Labeling” attachment to the Industry Letter, EAR procedures would start with the receipt, either by a manufacturer or by the FDA of “new safety information,” an already defined term in the statute:

The term “new safety information”, with respect to a drug, means information derived from a clinical trial, an adverse event report, a postapproval study . . ., or peer-reviewed biomedical literature; data derived from the postmarket risk identification and analysis system . . .; or other scientific data deemed appropriate by the Secretary about –

  1. a serious risk or an unexpected serious risk associated with use of the drug that the Secretary has become aware of (that may be based on a new analysis of existing information) since the drug was approved, since the risk evaluation and mitigation strategy was required, or since the last assessment of the approved risk evaluation and mitigation strategy for the drug; or
  2. the effectiveness of the approved risk evaluation and mitigation strategy for the drug obtained since the last assessment of such strategy.

21 U.S.C. §355-1(b)(3).  Alternatively, the information could be “received through the Sentinel System (see here for more details on Sentinel) and/or other databases including global sources that are suggestive of a need for a label change.”  Industry Letter at Attachment, p.1.

Rather than have individual companies guess when a label change is required, EAR takes advantage of the FDA’s central role as the repository of all post-marketing reporting information:

[N]o individual applicant holder has access to all the available data – the proprietary data from clinical studies conducted by NDA holders, and/or the data held and/or provided by each individual applicant holder. . . .  Unlike individual applicant holders, FDA possesses all the significant clinical trial data on a pharmaceutical product and all the adverse event and periodic reports from all manufacturers.

Id..  Putting all this information together, allows the FDA to “perform signal identification” – that is, to see the “red flags” that plaintiffs love to assert (inevitably with the basis of hindsight) in product liability litigation.

Expedited EAR safety review can be sought by industry “who believe data they are submitting to FDA might constitute ‘new safety information,’” or by the FDA on its own initiative, whenever  it “determine[s] that it is in possession of ‘new safety information’ from all the resources available to it.” Id. at p.2. Once an EAR is commenced, the Agency must act quickly:  The industry proposal did not presume to specify the exact time, but it is intended to be quite short – “days,” not weeks or months:

FDA must make a decision on the appropriateness of a label change within XX days (or sooner if FDA determines the circumstances warrant more expedited action). During that XX‐day period, FDA engages the NDA and ANDA holders in discussions regarding the potential for a label change.  Once FDA determines whether a label change is required, FDA immediately notifies the NDA and all ANDA holders of the decision.  If the decision is to implement new labeling, NDA and ANDA holders implement the change within 30 days (or sooner if FDA determines the circumstances warrant more expedited action).


Thus, the EAR proposal sets deadlines for results as well as reporting.  It contrasts mightily with the existing Changes Being Effected process for branded/innovator drugs, where “new” is not as precisely defined and where the FDA acts, or doesn’t act, however and whenever the agency decides on a case-by-case basis.  Nor does EAR have the inherent tendency towards confusion as in the FDA’s proposal.  EAR would eliminate even the possibility of disparate labeling and different manufacturers of bioequivalent products will never have to guess (with possible “devil take the hindmost” litigation consequences) whether or when to submit changes via CBE, or what those changes should say:

If FDA determines through a review of all available safety data that a labeling change is required, FDA informs the NDA and ANDA holders of the content of the final labeling language immediately (within 15 days) and instructs the NDA and ANDA holders to update their labeling within 30 days via e‐labeling.


We have always been in favor of what we’ve described as a “high regulation, low litigation” model for ensuring the safety of prescription medical products.  While the FDA isn’t perfect (as its generic labeling proposal alone demonstrates), compared to the cost and uncertainty of litigation almost any type of administrative action is far preferable.  EAR would be a significant step towards this goal, as replacing the ad hoc CBE process for label changes with a single procedure for all drugs backed by FDA mandate would overturn Levine rather thanMensing and allow preemption to clear most of the lawyers (on both sides of the “v.”) out of the drug labeling process.

EAR – (1) It ensures that safety decisions are based on all available information, not just the slice that any individual company has.  (2) It’s consistent with the statute, and thus within FDA’s power to adopt, without years of legal haggling.  (3) It would eliminate discrepancies that the Supreme Court criticized between FDA generic and branded/innovator drug label change procedures.  (4) It would replace current confused and free-for-all system for branded/innovator label changes with strict deadlines and mandatory revisions.  (5) It would reduce litigation.  For all of those reasons, it should be adopted, but, for the same reasons, probably won’t be by the current FDA.