Outrage of the Month: FDA Moving at a Snail’s Pace in Regulating Over-the-Counter Pharmaceuticals

Health Letter, September 2014

By Michael Carome, M.D.

outrage

If you’re not outraged,
you’re not paying attention!

Read what Public Citizen has to say about the biggest blunders and outrageous offenses in the world of public health, published monthly in Health Letter.

In an article published in this month’s issue of Health Letter, we discuss Public Citizen’s July 28 petition to the Food and Drug Administration (FDA) seeking a ban on all over-the-counter (OTC) benzocaine products marketed for relief of teething pain in infants because they can cause a rare but potentially fatal adverse reaction — known as methemoglobinemia — and provide little benefit.

Remarkably, it is actually illegal to market OTC benzocaine products — and many other medications for treating oral health problems — because the FDA has never issued final regulations permitting them to be legally sold in the U.S. In fact, according to the agency, there are at least two dozen categories of currently marketed OTC medications for which the FDA has failed to complete the regulatory process that would allow the legal sale of these products.[1] The agency has further acknowledged that it may lack sufficient data to determine whether these products are safe or effective.[2]

The agency nevertheless — using what is commonly referred to as its “enforcement discretion” — allows these products to continue to be sold pending completion of the final regulations.

The FDA has had more than four decades to complete the necessary regulatory process for these OTC medications or to take action to remove them from the market.[3] In 1972, the FDA initiated a multistep regulatory process that was intended to bring all existing OTC drugs marketed at that time into compliance with U.S. drug laws enacted in 1962. The process, known as the OTC Monograph Process, permits marketing of only OTC drugs that have been generally recognized as safe and effective when sold and used under conditions specified in a final FDA regulation called a final OTC monograph, unless the FDA has approved a separate new drug application for a specific drug product.

For OTC benzocaine products and many other OTC oral health care products, the first several steps of this regulatory process were completed by 1991, including the second-to-last step: the issuance of a proposed final regulation. However, the FDA has failed to complete the regulatory process by issuing a final monograph.

At a Feb. 24 meeting convened by the FDA to receive public input on possible changes to the OTC Monograph Process, Dr. Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research, offered excuses for the agency’s failure to complete the regulatory process for many OTC drugs, noting that the process was “inefficient” and not able “to accommodate innovation.”[4]

While the procedure for regulating these products may need to be modified to be more efficient, such decades long delays in completing regulations that are intended to protect the public from dangerous or ineffective OTC medications are inexcusable. They reflect a fundamental failure of the agency’s leaders to appropriately and effectively manage resources and priorities. What we really need at the FDA are new leaders.


References

[1] Food and Drug Administration. Over-the-counter drug monograph system: Past, present, and future: Public hearing transcript. March 25, 2014. http://www.fda.gov/downloads/drugs/newsevents/ucm395178.pdf. Accessed August 17, 2014.

[2] Ibid.

[3] Food and Drug Administration. Over-the-counter drug monograph system—past, present, and future; public hearing. February 24, 2014. 79 FR 10168-10172. https://www.gpo.gov/fdsys/pkg/FR-2014-02-24/pdf/2014-03884.pdf. Accessed August 18, 2014.

[4] Food and Drug Administration. Over-the-counter drug monograph system: Past, present, and future: Public hearing transcript. March 25, 2014. http://www.fda.gov/downloads/drugs/newsevents/ucm395178.pdf. Accessed August 17, 2014.