Our last post was about this new formulation, Tarex™ from Highland Pharmaceuticals, that holds promise in being able to get ephedrine and pseudoephedrine over the counter again. No prescription required, no ID check or form signature for NPLEX tracking reasons, not even sales behind the counter: a kind of dream for millions of people suffering from cold, flu, allergy or asthma.
As you can guess, we had long discussions in the team about the possible developments and we did a bit of “political fiction” that we would like to share with you
Let’s have a close look at the possible consequences for all concerned people.
In case Highland Pharmaceuticals gets exemption from the Combat Methamphetamine Epidemic Act 2005, they will be able to sell their product over the counter and the next logical step would be that politicians take this new factor into account in the local and state laws. A smart way to close the long lasting issue around the legality of ephedrine in the USA would be to find a win-win solution in the current debate:
- cops are in favor of a law requiring a prescription for ephedrine
- patients and physicians are strongly opposed to such law which would put an unfair burden on law-abiding citizens
Based on the new situation, this win-win solution could be to envisage a state law that would require prescriptions for pseudoephedrine and ephedrine produced in the old way, thus still usable as precursor of methamphetamine, but the smart idea would be that this same law would do an exception for the new meth-resistant products which could be sold over the counter. We have a very good example with the St. Charles County ordinance which already includes a clause of exemption from the prescription’s mandate for pseudoephedrine products that proved they could not be turned into meth. Such ordinance could establish a kind of case law statewide and would consequently relief counties and cities from local ordinances (thanks to Gabrielle Biondo, Editor for the Town and Country – Manchester Patch website, for all information we got from her articles).
As you can guess, the announcement by Highland Pharmaceuticals of a new met-resistant formulation has been a shock for all producers: as a real breakthrough innovation, this new concept could have a major impact on the sales of the new product Zephrex-D and a very negative one on the sales of its rivals.
- One point is sure: the current pseudoephedrine-based products like Sudafed, Claritin D, Advil, Mucinex D or Zyrtec D will remain controlled if their formulation process is not modified.
- The question will be about production cost and patents: will Highland Pharmaceuticals sell the Tarex™ patent rights to the other producers or will they keep their competitive advantage?
- In what extend will Zephrex-D affect the sales of all controlled products if a prescription is required for them, when Zephrex-D will go to store shelves as OTC medication?
- It also depends on the size of the market: the legality of ephedrine in Europe is not the same as in the USA or in Canada, what is the part of sales of ephedrine in the US compared to the rest of the world? Will the other countries just copy the American example, as they did for the FDA ban? Will they authorize meth-resistant formulations to be sold over the counter?
- There is another point to be considered: will this new product from Highland Pharmaceuticals, Zephrex-D, be as effective as the competition despite the new formulation?
- Last point: what will be the wholesale price? Highland Pharmaceuticals claimed that it would be only 10% above the current price of similar pseudoephedrine medications, but this has to be verified later on.
The economical implications have been clearly seen by some politicians at the Missouri House committee who already asked about the huge selling advantage that Highland Pharmaceuticals would gain from a law requiring prescription to all competitors and allow Highland Pharmaceuticals to sell over the counter. Highland president and CEO Jim Bausch had a laconic reply to that, saying about the big pharmaceutical companies: “Their approach has been to fight us“. Nevertheless Bausch says that Highland Pharmaceuticals is willing to help his dear colleagues to develop their meth-resistant pseudoephedrine too. We would love to hear about the price of this help
The Consumer Products Healthcare Association, representing the makers of over-the-counter medicines, said that they were taking a wait-and-see approach on this new technology.
To sum it up, the new formulation has severely weakened the position of the other pharmaceutical companies: first it might encourage politicians to pass laws requiring prescription, thus making cops, patients and doctors all very happy and leaving the pharmaceutical industry without arguments. And second, they will have to react, either by investing in new formulations or by paying to use Tarex™. In all cases they lose profits.
- The new extraction resistant formulation will for sure have an effect on the meth production, by making it so hard for meth cooks to find usable pseudoephedrine that it will probably result in a decrease of the so-called ‘ma-and-pa’ meth labs.
- We have no idea how the meth market will evolve, we just can guess that it will remain attractive in terms of demand: meth addicts are not addicts because of meth but because of profound causes which would lead to other addictions if meth was not available anymore.
- If meth becomes harder to find, they will switch to another drug, or the supply source will move to professional labs in Mexico or other classical countries of origin like in Southeast Asia for instance. Have a look for instance at this article from the Huffington Post about a seizure of 15 tons of pure methamphetamine in western Mexico …
- The meth market will change from a home-cooked drug to an industrial level with a higher entry price in the US, more middlemen, in other words it will get closer to cocaine and heroin. This will have an effect on price: the current wholesale street price is close to $25,000 per kilo, no doubt that it will raise to higher levels soon.
Law Enforcement Officers
This new drug environment will be a relief for local law-enforcement officers, as they will have less boring administrative stuff, for instance due to the NPLEX system, and as meth combat will go more professional they will probably step out of this role that they never really liked (some gossips say that it is the core reason of their active lobbying toward politicians for prescriptions laws). They will finally be be confined to a local role, supporting the DEA specialists. They will be happy to stop doing live surveillance of pharmacies, with officers sitting in parking lots with their binoculars, or risking their lives when cleaning meth labs full of highly flammable chemicals. Regarding the administrative burden that the NPLEX has put on them, we don’t really think that cops have been very proactive on such change management or that they have tried to identify potential trafficking patterns: most of them recognize that they didn’t change their habits and that they are still getting their information through the usual sources such as domestic violence cases, etc…
Doctors and pharmacists
Sales of ephedrine over-the-counter would reduce the administrative workload for physicians and pharmacists who are currently busy with “gate keeping” activities such as filling out forms, checking IDs etc… We know many of them who would be happy to stop this law enforcement role and to focus on their real job, taking care of patients. It is not a secret that most physicians are against laws requiring a prescription for pseudoephedrine-based products.
Last but not least: most benefits would go to the patients who suffer from cold, flu, asthma and allergy. We know that in their vast majority, patients were strongly opposed to prescription. If pseudoephedrine becomes an OTC drug, they won’t have to plan a trip to the doctor with all the fun in the waiting room, considering also the higher health price for people with limited resources or those without health insurance.
That’s it for now, in the next post we will give you our best guess about the future official position regarding ephedrine for sale as diet pills, and if there is a chance that the new extraction resistant formulation could be a game changer in the weight loss market.