The U.S. Food and Drug Administration (FDA) is proposing sweeping changes to how it regulates over-the-counter (OTC) drugs from aspirin to allergy medications to make it easier to react to new information on a product’s safety or recommended use.  The agency’s announcement follows a ProPublica investigation focusing on acetaminophen, the active ingredient in Tylenol, which is among the drugs that fall within the review.

The agency’s current rules for nonprescription medicines are more than 40 years old and do not require manufacturers to obtain approval as long as the main ingredient has previously been deemed safe and effective for the entire category of medications. FDA officials have complained that the system, known as the monograph process, has been in place since the early 1970s and is too slow to adjust to emerging safety issues.

There are a number of challenges FDA will need to address with the monograph system and the OTC Drug Review.  First, FDA will need to address the large number of existing products marketed under the OTC Drug Review that do not have final monographs. It is clear an efficient mechanism must be created for finalizing the status of drug products currently marketed under “pending” Tentative Final Monograms (TFMs).  Next, FDA will need to determine how to best alleviate concerns around safety and effectiveness issues while not burdening manufacturers with undue cost and regulatory constraints. FDA must respond in a way that does not impeded the availability of these products for general public usage, while addressing the need for clarity around dosage information, especially among pediatric products.  Additionally, FDA will need to assess how to accommodate innovative changes to products regulated under the OTC Drug Review.  The agency must be willing to embrace innovation as manufacturers seek an ever present need to differentiate themselves in the market place.

Implications for OTC Manufacturers

Although revisions to the monograph system are early in the consideration process, OTC manufacturers should prepare themselves to experience some level of change.  Assuming that the solution will make the FDA more nimble to responding to safety concerns, manufacturers will most likely need to invest in processes and systems that allow for agility in manufacturing, labeling, packaging and distribution.  Manufacturers that produce products with acetaminophen are already experiencing some of this with both the front package panel and the Drug Facts label now required to call out the word “acetaminophen.”  Also, if the solution does provide FDA with an increased ability to request additional information on products, manufacturers will need to have processes and documentation in place for efficient response.  Lastly, because pediatric dosing has been a hot topic, it would be expected that drugs with pediatric uses will need to provide additional data and work to ensure clarity of their labeling.

As part of the process, FDA will hold a public hearing on March 25 and 26, 2014 to obtain comments from the public on the monograph system.  A significant player in this hearing will likely be the Consumer Healthcare Products Association (CHPA), an association that represents manufacturers and marketers of OTC products. Clarkston is anxious to participate in this discussion and offer advice from our experiences assisting clients in both Consumer Products and Life Sciences industries. Clarkston agrees with the CHPA who stated on their website that they “welcome an opportunity to highlight the consumer and public health benefits of the OTC monograph system, as well as the opportunity to provide suggestions for improving it.”  How this plays out will have significant ramifications for Clarkston’s clients in the Consumer Healthcare space and for consumers who use non-prescription drugs to treat the myriad of diseases that affect daily lives.

Look for more to come on this topic as the dust settles.