FDA to Decide if Allergy Drugs Should Be OTC
By Lisa Richwine
WASHINGTON (Reuters) - As spring sends allergy sufferers flocking to doctors for relief, US regulators are weighing whether three popular prescription remedies should be available over-the-counter (OTC)–against the drug makers’ wishes.
In an unusual case, WellPoint Health Networks Inc., one of the nation’s largest managed care companies, has petitioned the government to switch Schering-Plough Corp.'s Claritin, Aventis SA’s Allegra and Pfizer Inc.'s Zyrtec to nonprescription status.
WellPoint estimates the switch could save it about $45 million a year in prescription drug costs. Drug makers typically reap the highest profits from prescription products and oppose the change.
For the nation’s 40 million allergy sufferers, nonprescription drugs may be more accessible, but the change would shift costs from insurers to patients.
Can/Should the FDA have the authority to change the status of these antihistamines to OTC, against the wishes of the drug manufacturers. As a user of Claritin (my script plan sucks…I pay $35 per month of drugs still on patent), I think that I could benefit in such a situation. Those who have better plans might end up paying more per month.
Of course the HMOs are trying to save money in such a scenario as well…and the drug companies are trying to squeeze out their 17 years of patent money to recoup their R&D and pay their shareholders.
I think doctors should be able to write prescriptions for drugs available over-the-counter, and have the insurance companies pay for said “prescribed OTC” drugs the same way they pay for prescription-only drugs now. The insurance companies would not have to pay for OTC drugs purchased without a prescription.
This might actually reduce the costs insurance companies have to pay, since OTC drugs – even OTC drugs for which doctors can write a prescription – will still be cheaper than prescription-only ones. (It won’t reduce their costs as MUCH as if they didn’t have to cover any OTC drugs at all, of course.)
I don’t think that there was any particular reason to make them prescription-only in the first place other than lobbying by the drug companies. According to the Physician’s Desk Reference (1999 - sorry, the most recent that I’ve got), the only known drug interaction of Allegra is that at twice the recommended dose, it increases the length of time that Erythromycin and Kotoconazole stay in the blood. It’s hard to overdose on, and there are no major side effects. Claritin has a similar profile, as does Zyrtec. There was no reason to make these prescription at all - the main reasons to do that are: [ol][li] It has bad interactions with certain other drugs that doctors need to watch out for []People with certain conditions shouldn’t take it []Hi Opal! (I’ve never done that - first time for everything, I guess) Bad stuff will happen if many people take it unnecessarily (why antibiotics should stay prescription, IMHO - they’re overprescribed already).[/ol] This isn’t true for any of these three drugs. Nothing bad has been documented in Canada because these drugs are OTC there.[/li]I also think that it’s rather silly that it’s cheaper for me to fly to Toronto, buy a three months supply of Allegra for three people and come home than it is for me to buy it at the local drugstore.
I do recall that (I believe) Seldane and Hisminal, 2 other non-drowsy antihistamines, were taken off the market a few years ago due to some perceived risks…could that be playing a factor in this (from the FDA point of view?)
One thing is certain regarding these drugs. Any decision to make them ‘by prescription only’ is not based on safety considerations.
The older antihistamines (such as Benadryl and Chlortripolon, which, by the way, are also what’s in Gravol and Sominex) are much more likely to have adverse effects. Although such effects are usually harmless (dry mouth, mild sedation) things like delirium (especially in old folks), urinary retention, and visual changes can all occur. More importantly, these “first generation” antihistamines can be fatal if taken in overdose. Notwithstanding this potential for side effects and even death, none of these drugs requires a prescription (in Canada at least).
Conversely, to my knowledge, drugs like Allegra and Claritin are virtually side effect free - even in overdose. Yet they require a prescription (in the USA at least. In Canada they’re OTC as has been noted).
I was not aware that the H1 blockers were OTC in Canada. Out of curiosity, how much do they cost (say, for a month’s supply of Claritin)?
Drug companies can charge $50-60 for a month’s worth of one of these drugs because it is usually covered by health insurance. If they charged that over the counter, more people would either opt for the $5 Benadryl and put up with the side effects or just do without.
KarlGauss beat me to the point about Benadryl. BTW, that’s what Sally Field’s character ODd on during last week’s episode of “ER”. It appears she’s going to be OK, but it does put aside the delusion that prescription=dangerous and OTC=harmless.
Seldane (terfenadine) and Hismanal (astemizole) didn’t just have perceived bad side effects. IIRC they led to a prolongation of the QT which led to fatal arrhythmias in quite a few people (polymorphic ventricular tachycardia or torsades des pointes).
I bought Claritin OTC in South Africa. I think one of the justifications of not making a new drug OTC immediately is that much of the long-term toxicity data comes from post-marketing studies. Keeping the drugs prescription ensures that for someone to be on long-term drugs, they have to periodically seek out medical attention, where any weird findings are more likely to be picked up.
My suitemate’s parents bought me a very large supply of Allegra on a trip to Toronto last week. It cost them $15 Canadian (about $10 US) per 18-day supply. This works out to $25 Canadian per month, as compared with $70 American per month at my local Rite-Aid.
There’s also a website where you can buy 120 pills (two months worth) for $70 US plus shipping. It’s a huge markup from the Canadian price, but half of the American one. There’s probably something similar for Claritin, but since it doesn’t work for me, I haven’t looked for one.
How long do the patents on these drugs last? I thought it was 7 years, not 17 as stated in the op. Please give me a cite on that if you can, not 'cause I’m trying to argue, but because it’s something I’ve been wondering about lately. I’m pretty sure I’ve been taking Claritin for longer than 7 yrs, and pretty pissed that there isn’t a generic version yet. I’m not real happy with having to pay a doctor to prescribe it when it’s obvious I need it (had the bed of nails test done on me 3 times over the last 10 yrs, had nickel sized wheals {not a typo} on all but the control.) But the issue of whether it’s OTC or prescribed doesn’t cost me as much money as the patented/generic issue does. Claritin is like $75 for 30 @ 10mg here in Tennessee.
Since your op was about OTC vs prescribed, did you hear about what the patent holders of Prozac are doing? The patent runs out in a few months but they’ve managed to get a new one for the same chemical under a different name simply because they “discovered” a new use for it. They’re calling PMS by a different anagram and making women pay an exhorbitant price to treat the depression associated with it because Prozac is going to have competition soon and they won’t get as much money off it. I wish I had a cite for this, I can’t even remember the pharmaceutical company’s name, but Prozac has been their bread and butter for a while now. They’ve recently spent millions on ad campaigns promoting the idea in women’s heads that they need this “new” stuff. Sidestep the question of whether doctors should be prescribing this stuff like Tylenol to anyone who complains about getting pissy every now and then, and tell me … do they have an ethical responsibility to let patients know that they can get the same chemical with a different trademark for a lot less money?
Since we seem to have lots of medical science-type people checking in here, let me toss in a semi-related question. I used to take 40mg of Pepcid each day (I’ve since been moved over to Prevacid). That is a “prescription strength” dose. But Pepcid is also available OTC in the form of 10mg pills. What’s to stop me from popping four of those per day, essentially writing my own prescription?
In fact, I had to do this once when I found myself unexpectedly out of town without my prescription. I went to the local Drug Fair and bought a 50 pack of 10mg pills and took 4 per day. Seemed to work just fine; kept me acid-free the whole week.
Sure, nothing stopping you from doing it that way. But if your health insurance picks up prescription costs, or at least subsidizes them, it’s probably a lot cheaper to get it in Rx strength.
Also, it’s getting so we’ve got a nation of people on acid blockers (like pepcid) or proton pump inhibitors (like prevacid) without a lot of real criteria as to why they’re taking them. the PPI’s in specific should be used long term only if there is documented erosive gastritis on endoscopy, or intractable peptic ulcer disease (real rare that it can’t be cleared up quickly with triple therapy these days). A lot of my patients have a few days or weeks of heartburn from dietary indiscretions, then stick themselves on acid blockers for the rest of their lives! It’s not good practice.
Do insurance companies, as a matter of general policy, not cover the cost (or any part thereof) of OTC medication even if it is expensive and directed by your doctor?
Q. When does a brand name drug “become” generic?
A. When a drug is first developed, it is protected by patent for seventeen years. The company that holds the patent has exclusive rights to manufacture and market the drug. However, when the patent expires, other companies may produce and sell the drug with FDA approval. These become the generic forms of the drug.
also… http://www.fda.gov/fdac/special/newdrug/benlaw.html
Drug Price Competition and Patent Term Restoration Act (1984): This law expands the number of drugs suitable for an abbreviated new drug application, or ANDA. ANDAs make it less costly and time-consuming for generics, which are often sold at lower prices than brand-name drugs, to reach the market. “Patent Term Restoration” refers to the 17 years of legal protection given a firm for each drug patent. Some of that time allowance is used while the drug goes through the approval process, so this law allows restoration of up to five years of lost patent time.
As a general rule, no insurance company picks up the cost of OTC drugs unless you have a reimbursement policy through your employer that is generous enough to include them. However, there are occasions where I will request a prescription for drugs that are OTC; for example, pain medication that I can get OTC (like Motrin or Aleve) because it’s much cheaper to have my insurance pay for them than it is for me to buy it over the counter.
Also, for some medications, some insurance companies (especially managed-care companies) require evidence of failed drug trials before they’ll approve more expensive, current medications. So, in some cases, it actually pays to have a prescription.