Spelling Counts (Among Other Things): FDA Issues Warning Letters for Mistakes in Drug Listing

Background

Recently, the Food and Drug Administration issued two Warning Letters to pharmaceutical companies for failing to fulfill product listing obligations for what appear to be oversights. In the first letter issued at the end of April, FDA said the lists of active ingredients in the product listing and in the product labeling did not match. The listing included an active ingredient not found in the product labeling, and the product labeling contained an active ingredient not found in the listing. The agency also noted and requested correction of a spelling error in one of the ingredients. In the second letter, issued June 1, FDA again found a discrepancy between the active ingredients in a product label and in the listing information.

In each case, the agency said that the failure to fulfill the listing obligation rendered the product misbranded. In addition to sending out the Warning Letters, FDA removed each product’s listing information from the National Drug Code (NDC) directory made available to the public until the corrections are made. In removing the listings from the NDC directory, FDA stated, in each letter, that it did so in an “effort to protect and promote the public health.”

AGG Observations

• We don’t know why FDA looked at the listings for these particular products carefully, but what appear to be relatively minor mistakes resulted in not only issuance of a Warning Letter, but also in removal from public access of what may be an important source for confirming NDC numbers. 
• In some companies, listing is sometimes treated as a literal check the box task, but it must to be done carefully and by someone who will compare the list of ingredients to the correct label and will also catch spelling mistakes. The misspelling wasn’t for a particularly esoteric ingredient – “sulfer,” which might have been a particular concern to the FDA. 
• While, in these cases, FDA issued Warning Letters, the agency could also issue an Import Alert for a similar violation to prevent violative products from entering the United States. This can result in significant shipment delays and financial losses. Fixing even minor technical errors can take weeks, if not months. 
• Of note, although the product that was the subject of the April letter is an unapproved prescription drug, the Warning Letter did not take issue with or refer to the drug’s regulatory status. 
• Typically, we see FDA taking action for much more substantial issues, such as quality-related issues or unapproved products. However, laws are laws, and noncompliance is noncompliance. Therefore, companies must remain vigilant and deliberate when ensuring compliance with, perhaps, even more ordinary and mundane requirements.

To review the entire document and formatting for this alert (e.g., footnotes), please access the original below: