This article originally appeared on Beacon, where Jonah Engle writes about drug policy, and is posted here with permission. Subscribe to Engle's work on Beacon to receive new stories each week.
This is the second in a two-part series. Read part one here.
As flu season approaches, Westport and Acura are pushing to get their products in as many pharmacies as possible. Zephrex-D and Acura are now both available across the country. As of last month, Zephrex-D was being sold in more than 15,000 pharmacies including Walmart, Nexafed in at least 2,600 pharmacies.
But for customers who hope they can now buy pseudoephedrine products off the shelf and not have to show their ID — as is the case for cold and allergy medicines that don't contain pseudoephedrine — that day has yet to come. Under the Federal Combat Methamphetamine Act of 2005, all pseudoephedrine has to be kept behind the counter. Purchasers must also show ID and are limited in how much they can buy per month and per year without a prescription.
>Westport requested an exemption from this regulation on the grounds that its product's built-in protections made it unlikely to be diverted, but the DEA denied this request.
In a written response to questions about the regulation of Zephrex-D, the DEA said it “welcomes the efforts of companies to develop products that deter the production of illicit drugs. While this particular company claims that their 'drug delivery system provides a new and unconventional approach to combat drug misuse,' this product can still be utilized to manufacture methamphetamine. As such, controls on this product cannot be relaxed as this product does not meet the exemption criteria under the Controlled Substances Act.”
Jason Grellner explains that under federal law if any pseudoephedrine can be extracted from a drug, no matter how little or how or impractical for the manufacture of methamphetamine, it must be regulated like any other pseudoephedrine product.
While Grellner doesn't expect these new tamper-resistant products to be turning up at meth lab sites, he thinks the DEA's caution is not a bad idea. Over the years, meth cooks have been nothing if not resourceful. The spread of the now dominant Shake 'n' Bake or one-pot method, which requires little pseudoephedrine, was itself an adaption to the sales limits imposed by the Combat Methamphetamine Act.
How the large pharmaceutical companies which dominate the more than half a billion dollar a year pseudoephedrine business will respond to these upstarts is not yet clear. Between them, Pfizer, Johnson & Johnson, and Merck produce 13 of the 15 name-brand pseudoephedrine products sold in the United States.
Johnson & Johnson's McNeil Consumer Care said in a written statement, “we are concerned about methamphetamine abuse and continue to work with others in our industry to find ways to help law enforcement control the sale of pseudoephedrine for illicit purposes while also ensuring those who rely on our products can have access to them.”
The company said it has followed research into efforts to prevent the extraction of pseudoephdrine to make methamphetamine but was “aware of no technology that has proven effective in doing so,” noting that the DEA had yet to recognize a sufficiently conversion resistant technology.
The company noted its support for the National Precursor Log Exchange (NPLEx) — which alerts retailers and allows them refuse an illegal sale of pseudoephedrine. Pfizer, in a written statement, also emphasized its support for NPLEx as evidence of its commitment to prevent diversion of pseudoephedrine.
But there are signs that makers of regular pseudoephedrine products are concerned that these new tamper-resistant formulations may present a threat to their market share as pressure continues for the greater regulation of pseudoephedrine.
Half the states in the country have considered making pseudoephedrine available only by prescription as a means of preventing the spread of meth labs. In large part, through the lobbying efforts of the Consumer Healthcare Products Association (CHPA), which represents makers of over-the counter medicines, drug companies have been successful at stopping all but two states from passing these laws.
Most states which have had NPLEx in place for over a year, have continued to see rising numbers of meth labs. In light of this fact, and the defeat of pseudoephedrine prescription bills at the state level, cities and counties are passing their own laws. Over 70 cities and counties, mostly in Missouri, have adopted local ordinances making pseudoephedrine a prescription drug in the last four years.
In Franklin and Jefferson Counties in Missouri, the new prescription laws allow for the exemption of tamper-resistant pseudoephedrine products such as Nexafed and Zephrex-D. That has got the Consumer Healthcare Products Association crying foul. Speaking at a hearing on prescription legislation in West Virginia this week, CHPA's Senior Director of State Governmental Affairs, Carlos Gutierrez argued against any exemptions saying they amounted to a “government-sponsored monopoly.”
Jason Grellner, who has lobbied extensively for pseudoephedrine prescription laws, supports these exemptions and battled with CHPA over this issue at the state level last year. “Why would the Missouri state legislative body not want to end meth labs and allow patient access, especially when the company that has come up with this idea is a Missouri company,” says Grellner.
This is the second in a two-part series. Part one here.