The New Jersey Supreme Court ruled on August 22 that consumers’ state-law claims that manufacturers of a generic Reglan, a heartburn medication, did not adequately warn about its risks are not preempted by federal law.[1]

Under the Federal Food, Drug, and Cosmetic Act, manufacturers of brand-name drugs must seek approval from the FDA to market the drug and must prove that it is safe and effective and that its proposed label is accurate and adequate. Generic drug manufacturers, however, face a more streamlined process: they can gain FDA approval of a generic drug simply by showing it is identical in active ingredients, safety, and efficacy to a brand-name drug that has already been approved. Similarly, the brand-name manufacturer is responsible for the accuracy and adequacy of a drug’s labeling for new drug applications and updated labeling, while generic manufacturers are responsible for ensuring that the labeling is the same as the labeling approved for the brand-name drug.

When it comes to matching an updated label, generic manufacturers are required to update their labeling at the “very earliest time possible.”[2] Generic manufacturers must therefore routinely monitor the FDA’s website for information on changes in labeling and/or obtain the information in other ways, such as from the FOIA staff at the FDA. Read more ›

The Food and Drug Administration released draft guidance last week revealing its intent to better track medical devices, from pacemakers to condoms, through an amendment to its 2013 “UDI (unique device identifier) Rule”.  The draft guidance is intended to assist both labelers and FDA-accredited issuing agencies to better ensure the UDIs are in compliance with the Rule.  The UDI Rule established a tracking system to adequately identify devices through distribution and use throughout the United States.  Under 21 CFR 801.20, a UDI is required on the label and package of every medical device in commercial distribution in the United States (unless an exception or alternative applies).  Read more ›

On July 8, 2016, the U.S. Food and Drug Administration released draft guidance amending the process for manufacturers to update labeling of generic drugs in situations where the reference drug labeling has been withdrawn for reasons other than safety or effectiveness.

The FDA generally requires a generic drug to have the same labeling as the reference drug at the time of approval.  Moreover, all marketing application holders have an ongoing obligation to ensure that their product labeling is accurate, and not false or misleading.  In particular, when new information becomes available that causes the labeling to be inaccurate or misleading, the application holder must update its labeling.

Where the reference drug is still on the market, the reference drug manufacturer frequently proposes changes to the labeling, and generic drug manufacturers are expected to update their labeling accordingly to reflect any approved relevant changes.  While this process is fairly clear cut, the FDA admits there is confusion about what generic drug application holders must do to update labeling when the reference drug is off the market (for reasons other than safety or effectiveness).  This draft guidance seeks to clarify that process. Read more ›

This week, on June 14, 2016, the FDA issued a final ruling revising its medical device and certain biological product labeling regulations to allow, for the first time, manufacturers to use graphical representations of information on its labeling without adjacent explanatory text (known as “stand-alone symbols”).  The new ruling goes into effect on September 13, 2016.

The ruling brings the labeling regulations in line with the current use of symbols on labels in European and other foreign markets.  Thus, in the view of the FDA, this ruling seeks to “harmonize” the U.S. device labeling requirements for symbols with international regulatory requirements.

In addition to increasing consistency between U.S. device labeling requirements and international requirements, the FDA touts that, by allowing the use of stand-alone symbols, medical device manufacturers will experience a positive net benefit over time in the form of a reduction in costs for the design and redesign of labeling for medical devices currently marketed.

Specifically, the FDA estimated the total benefits annualized over 20 years to be between $7.7 and $25.5 million.  Of course, the switch to stand-alone symbols will require some up front and recurring costs to redesign the labeling and to create an accompanying glossary (more on this below), which the FDA estimates at total annualized amount of $1.1 to $3.2 million over 20 years.  Thus, the total annualized net benefit to medical device manufacturers stands to be in the range of $6.6 to $22.3 million.    Read more ›