Off the Cuff: Down the Rabbit Hole

In 1998, I was in my 3rd year of optometry school. I had heard rumors that one of the preceptors in my school’s clinic had his own stash of a dilating drop that he carried around in his lab coat pocket. What was so great about this drop, and why all the intrigue? It was a single drop, had a faster recovery and didn’t affect accommodation as dramatically than the traditional two drop regimen of tropicamide and phenylephrine. That’s when I first learned about Paremyd. Allergan had introduced it in 1993 and due to problems acquiring its main ingredient, hydroxyamphetamine bromide, they discontinued it in 1997. This preceptor was doling out the last of these drops that soon he wouldn’t be able to get in the foreseeable future.

Also in 1998, Akorn acquired Paremyd but didn’t begin production until 2002. Akorn was one of the largest generic pharmaceutical manufacturers in the US. Evidently generic manufacturers largely operate at break-even or at a loss. In 2022, they sold off some of their ophthalmic medication holdings to Thea including Zioptan?, Cosopt?, Cosopt? PF, Betimol?, along with Azasite?, Akten?, and AcellFX? but not Paremyd. Later that year they were fined $7.9 million under the False Claims Act for saying three of their generic medications were covered by Medicare Part D when they weren’t. That was essentially the nail in the coffin that found them filing bankruptcy and ceasing all operations in February 2023. This began a snowball of drug shortages in the US that continue to worsen and increase our dependence on foreign manufactured generic medications. I’ve learned that when the FDA inspects foreign facilities, they largely depend on information from translators supplied by the drug manufacturers.

When I began doing research for this article, I was just selfishly trying to find out who owned Paremyd and if any pharmaceutical companies were going to start manufacturing it again. Little did I know I would end up down a rabbit hole of FDA fines for regulatory violations, which essentially bankrupted Akorn, one of the few remaining American generic drug manufacturers. This then led US pharmacies and patients to become reliant on foreign manufacturers such as India and China, which are not subject to the same level of scrutiny, exposing us even more to potentially ineffective or tainted generic drugs. With Akorn out of business and Paremyd still listed as one of their holdings, I’ve read that generic equivalents are starting to surface. The warnings I’ve read about these generic equivalents that are being sold are that they may be counterfeit, foreign made, unsafe and aren’t FDA approved. How quaint, yet self-inflicted and inevitable. I absolutely get the importance of FDA rules and regulations for drug manufacturers but when those rules essentially kill an American manufacturer/industry, it reads almost like corporate espionage and is part of a bigger story yet to be told.

Shannon L. Steinh?user, OD, MS, FAAO - Chief Medical Editor

[email protected]