On February 17, 2011, U.S. Marshalls, acting under an order issued by the Food and Drug Association (FDA), seized all supplies of an ear solution called Auralgan. Their worth was estimated at $16.5 million. The reason? Because Auralgan had been deemed a “new and unapproved drug”. Since Auralgan was originally introduced early in the twentieth century, prior to the creation of the FDA, it had been “grandfathered” and had never gone through the FDA drug approval process.

Auralgan was used primarily for relief of ear pain. It was quite effective; many physicians (including me) routinely prescribed it for use in childhood ear infections. A screaming child would often fall asleep within minutes after several drops of the solution were placed in the affected ear. Since it was an old medicine it was available generically for under $15.

At first glance the FDA’s action seems outrageous, but there is more to the story. Auralgan was originally made up of three ingredients: benzocaine (a local anesthetic), antipyrine (an anti-inflammatory), and glycerine. Several years ago a company, Deston Therapeutics, LLC, purchased the rights to the brand name Auralgan. They then added two additional ingredients – acetic acid (vinegar) and U-polycosanol 410 (an insect wax extract).  While the additional ingredients would not be expected to improve the drugs pain-relieving properties, they did distinguish Auralgan from its generic competitors.  When Deston released the modified Auralgan formulation in April 2008 they priced it at over $200 per 14 cc (slightly less than 1 tablespoon) bottle.

Deston knew that physicians generally write prescriptions by drug brand names than by generic names. For example, it is faster and easier to write “Auralgan” than “antipyrine/benzocaine drops.” This is generally not a challenge. Unless a phrase such as “Substitution not allowed” or “No substitution permitted” appears on the prescription, a lower-priced generic equivalent will generally be dispensed at the pharmacy.

Deston was also aware that by adding the two new ingredients, pharmacists would no longer be able to dispense generic substitutes for the Auralgan brand. By obtaining the established Auralgan brand and changing its formulation they executed a clever and extremely profitable deception. Physicians who habitually wrote prescriptions for “Auralgan” thinking they were prescribing inexpensive pain-relieving ear drops were suddenly and unknowingly prescribing a drug priced in excess of $200 per bottle. Hopefully the FDA seizure will put an end to Deston's outrageous scheme.

Whether the FDA action will deter others from using this ploy remains to be seen. It is possible to learn from this episode, however. If you find that a prescription carries an unexpectedly high price tag ask the pharmacist if a less expensive product that is similar to the drug prescribed is available. If it is, call the prescriber’s office and request a substitution.

 

Dale Peterson, M.D.