Should Generic Pills Look Like Brand-Name Pills?
24 CommentsBy Ed Silverman // July 13th, 2011 // 10:53 am
Many years ago, there were a few common reasons for ensuring that brand-name pills were a different color and shape from generics. Besides the notion that a brand-name drugmaker was entitled to patent protection, there were worries that corrupt pharmacists would distribute counterfeit meds and that patients would inadvertently receive a drug that was similar, but not identical to another.
But are such concerns still valid today? In a recent editorial in The New England Journal of Medicine, a pair of Harvard Medical School researchers argue that such thinking is outdated and, moreover, contrary to sound public policy. Rather, they believe that generic copycats should, in fact, resemble brand-name pills whenever possible.
Why? They name three reasons - prescription error, medication adherence and the placebo effect. As they see it, the success of the FDA regulation demanding bioequivalence protocols for generics has greatly undercut the need to distinguish the look of generic versions from brand-name pills. And they suggest FDA certification of pill size, shape and color in the drug approval process.
To make their case, Aaron Kesselheim and Jerry Greene argue that patient adherence may be greatly increased if generics resemble brand-name counterparts, since many patients - particularly, the elderly - become accustomed to reaching for a certain pill as part of a medication regimen. And they note that direct-to-consumer advertising is a marketing tool that reinforces the look of a particular pill, such as the Nexium purple pill (here is the editorial).
“Everyone has seen a patient who has gone off of a medication because it changed color. It can lead to disastrous outcomes,” Greene tells The New York Times. “The current situation reflects an approach to public health law that made sense a half-century ago, but is no longer in sync with how people manage disease with generic drugs today.”
Not everyone agrees. Bob Lee, a trademark lawyer for Eli Lilly, says patients have a right to know when they are taking a generic, and a different shape or color makes this clear. And he points to ongoing counterfeiting as a good reason. “What they are really arguing for is a deception,” he tells the paper. But what do you think?
Should Generics Look Like Brand-Name Drugs?
- No (71%, 171 Votes)
- Yes (30%, 72 Votes)
Total Voters: 242
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Stewart Setter
Generics should not have to resemble the brand otherwise it would BE a brand.
original industry insider
I once had an eccentric uncle who only bought red Cadillac Sedan de Villes. He would absolutely have no other color or make. When the model design changed he would buy a used one just to make sure that he kept on getting the identical color, make and model. I stopped counting how many he bought long ago.
When I asked him the reason for his eccentric behavior he said that he wanted to make sure that he could always find his car in the parking lot after a show.
Generic drugs must be bioequivalent and pharmaceutically equivalent, and can be any shape, size or dosage form as long as the standards are met. Read the link to the Orange Book preface, guidelines for generic drugs. It says nothing equivalent dosage forms. The OB is revised periodically, bon\’t won\’t be revised over this issue.
original industry insider
Here’s the link.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm
Info RPh
It would make pharmacies that have a packager such as Talyst AutoPack and similar machines much easier. Right now there is a custom die that is geared towards the shape and size of the tablet or capsule. If all lisinpril 20 mg tablets were the same shape and size then my life would be much easier because especially in this time of shortages I never know what manufacturer my wholesaler is able to supply. Somedays I may have to rig an old canister to make it work and this isn’t always possible. Plus, once a drug loses patent, I could keep the same canister without missing a beat. Most of the time the first authorized generics are the same shape so it works but not always.
original industry insider
Info, I understand your situation. However, to require companies to retool their tablet presses or even have to purchase new equipment just because Grandma gets her pills confused would be cost prohibitive. Isn’t this where pharmacist counseling comes in? Isn’t it your job to point out to the customer these various differences? It would indeed make your job harder, but with all due respect, those pharmacy counseling fees you collect aren’t just for stuffing package inserts into paper bags.
JaT
I remember back when this was brought up, saying that the whole consternation over a “New Look” reformulated drug (brand to generic) caused the change in absorption rates to be undermined, directly because of that consternation claim over appearance. As if the other differences in the medication were unimportant (to the tune of 1500+ MedWatch reports of what - mass consternation?).
It is dangerous to have generics look the same in some cases, and should not only NOT be required, but discouraged. Much like not naming drugs with the same name prevents confusion.
Why would we keep doing things which makes consumers have to second guess and question and research and triple check everything to protect themselves? Who would this serve again? Consumers? Ummm no.
When I pick up my pills I check several things. First - appearance. Second - label for manufacturer (though the wrong label could be printed, and has, so appearance!). Third - NDC# (though the wrong label could be printed so APPEARANCE!)
Good Lord. Can we please not keep putting people, such as myself, back into a position of reliving something we have already lived? I adhere to my medication - which is a generic - and which is now DAWed because the innovator drug (which was also DAWed and was changed) forced people to have something else without time to titrate safely.
What exactly am I supposed to do to protect myself if this comes about?
Justice in MI
In my view, the problem is less that the generics don’t look like the brand, but that different generics don’t look like each other. My experience with the chains is that every month there is a different generic, no doubt depending on where the best deal can be cut.
I would say I still have most of my faculties and I’m even on a faculty. Nevertheless, if I’m looking for the little white oval which is now a little orange circle and which was a blue square the month before, I am sympathetic with “grandma’s” confusion and potential risk, and I believe that the issue should not be cavalierly dismissed.
JaT
The point is - if they all look the same then you do not know your meds are different from month to month. If you have a bad reaction to one - that is pretty valuable information. You can then go back and think about when you were doing better and which manufacturer gave you optimal health. Bioequivalency is not exact drugs from each manufacturer - as per FDAs own criteria. To make them appear as if they are the same does not change the differences.
Salient point
The authors are overstating the ramifications of 80-125% bioequivalence. There are certain Rx products–Synthroid & some AEDs come to mind–where doctors believe adherence to brand is important. The distinct appearance of the branded product is a crucial component of this.
original industry insider
A much larger problem than look alikes is sound alikes. I recall when the FDA was very slow to the game in forcing Astrazeneca to change the name of Losec to Prilosec, although patients were going into hypovolemic shock when pharmacists were filling Losec prescriptions with Lasix.
I can tell you from experience that it cost tens of millions of dollars to change the name of a drug after approval, if you think of all the things that have to be fixed, all at the company’s expense, the re-education, etc, all because of the ongoing dithering incompetence at FDA.
original industry insider
Salient, I can tell you from having worked on Synthroid that the reasons doctors believe that patients should not switch LT4 drugs is because we paid off the American Association of Clinical Endocrinologts, The American Thyroid Association, The Thyroid Society, and all the KOL’s we could buy off to make it so.
True confessions.
Angry PharmD
I see the Original Industry is still gracing this website with his insufferable idiocy. I try to glaze over your comments because they are usually so wrong, but today I apparently couldnt resist.
I’m not sure what your expertise/job is, (other than placing 30+ comments per day on this website) but I have worked in manufacturing and can tell you replacing punches and/or a small retooling is not “cost prohibitive.”
“Grandma getting her pills confused” can be a big deal! Replacing dies isnt. What is your priority?
Blaming the pharmacist (like a typical backward-thinking old burnt-out MD) further illustrates your industry-arrogance. If grandma is getting her pills confused, chances are she is old enough where her short term memory isnt working too well. Therefore what pharmacists council won’t help.
Your kind of know-it-all mentality and propagating of mis-information is the reason a lot of the public hates big pharma. It additionally points to a deeper psychological issue. I only wish I could filter out your asinine comments when I read this site.
PS: What is a pharmacy counciling fee? I ask only because they dont exist!
xtian
If generics have to look like the brand, does that mean they will have to have the same nice coatings on them. Some generics are so pasty and hard to swallow. Oh, but that would make the generics more expensive…..Convenience, safety, and cost. Where’s the balance point?
Salient point
original-I don’t doubt that the brand spent a lot of money protecting its business. But surely there’s some science behind this too, isn’t there? Just because vast resources were spent getting the story out doesn’t mean it’s completely untrue.
If it were as simple as paying off a bunch of KOL’s, every brand would do it.
how much does a prescription cost
Hello,
Thank you for nice writing. It will help me to understand, what prescription medications cost is?
original industry insider
PharmD, are they still teaching soda jerking as part of your training. Maybe that’s what you’re cut out for since you validate the idea that PharmD’s are nothing much more than a BS pharmacists with a year tagged on trailing behind the doctors on rounds, and giving advice that they don’t pay any attention.
AnnePME
It is less confusing if the generic does not look the same in the event that the patient has a reaction.
Also, any thoughts on how making all generics and the brand look the same might influence counterfeiting? My thought is that this would make it easier to counterfeit the drug.
original industry insider
Salient, here’s the scoop on how Boots protected the Synthroid brand by convincing doctors that LT4 preparations are not bioequivalent, and how patients needed to be retitrated when switching LT4 compounds:
Look up the saga of Dr. Betty Dong at UCSF. Dr. Dong did a study funded by Boots Pharmaceuticals in the late 1980’s evaluating the potential bioequivalence of Synthroid, Levoxyl, Levothroid and a cheap generic LT4. Her data showed the drugs to be essentially bioquivalent. Allowing this study to be published would have a huge negative impact on salers of Synthroid, their main product. However, because Boots was the sponsor and owned the data, the company suppressed publication of the study under threat of lawsuit against Dr. Dong and UCSF for breach of contract.
Not only did Boots suppress the Dong publication they published their own data discrediting Dr. Dong’s data as a “flawed study” as a defensive maneuver in case her data ever saw the light of day. Finally the FDA got wind of what was happening and forced Boots to allow Dr. Dong to publish her data in JAMA in 1997. Boots was then hit with a multimillion dollar class action lawsuit for defrauding consumers by suppressing the study, which Boots settled for $300,000,000. However, during the time the study was suppressed Boots made about $4-5 billion in Synthroid sales so it was money well spent.
It is summarized in a Wall Street Journal article in 1996 by Ralph King, entitled “Bitter Pill: How a Drug Firm Paid for University Study, then Undermined it.”
original industry insider
Xtian, film coating would not be a requirement IMO since the coating is invisible. In the old days companies made candy coated tablets until FDA stopped that. As long as the coating or lack thereof does not affect bioavailability or bioequivalence it would not be a requirement I would think.
original industry insider
PharmD, maybe not cost prohibitive for the parts, but expensive for the reasons below, and in this business time is money. Since you don’t appear to understand cGMP’s you need to know that such a change would qualify as a major manufacturing change under SUPAC. This means that in addition to preparing and submitting an amendment to the NDA you will have to update the Drug Master File (high paid regulatory and QA people do this), you will have to put production batches of the reconfigured tablets on stability testing (expensive) and you may have to undergo a plant inspection by FDA, which will invariably be disruptive. Thus while the parts may be less expensive the overall cost is up there because of all of the things I cited above.
Drug packaging and labeling has been dumbed down over the years to the extent that the next logical step would be to feed Grandma the pills directly.
Salient point
original-I looked up the JAMA abstract. Interesting reading.
Looks like the difference between Synthroid & the others was a P=.08. Not significant, but this is a pretty low P value for 22 patients. I can see how an endocrinologist could be persuaded that this could be problematic, especially given the variations within various generic formulations.
There’s no doubt that the story as a whole does not represent the industry’s finest hour.
original industry insider
Excellent catch, Salient. I’m actually surprised that Boots didn’t try to use this p-value as a “trend” towards a statistical difference. However they would have lost that argument because as you saw from the abstract the confidence intervals were rather tight (95-107%).
What Boots did show quite convincingly in a separate paper was that even so called bioequivalent LT4 levels among products still produced markedly different TSH levels, hence the argument to retest and retitrate. This phenomenon is based on the log linear relationship between T4 concentrations and TSH levels, i.e. even bioequivalent concentrations of serum T4 can produce bioinequivalent concentrations of TSH. Since TSH is the marker by which doctors judge the patient’s thyroid status, the TSH argument that Boots used to tell doctors not to switch made some sense, perhaps even more sense than the Dong paper, since clinicians’ eyes glaze over when reading BE papers.
Angry PharmD
original industry insider:
your last statement could also be summed as: “F#%k Grandma! Its too expensive, and we cant have it cutting into our industry profit, and more importantly, my year-end bonus!”
It would appear if this pharmacist “soda jerk” cares more about patients than you do, “doctor.”
What an embarrassment to the profession you are.
Jesse_EngAmer
The FDA is currently struggle to crack down on dangerous imported drugs through their 2011 Food Safety and Modernization Act (FSMA) yet their stance on this issue reflects a serious conflict of interests. The FDA’s reasoning only makes it easier to produce knock-off drugs and pass them off as the safe and recognizable brand-name counterparts. Furthermore, it will make it even more difficult to discern fakes and increase both the difficulty and costs associated with keeping them from reaching the American Public.
The FDA said in their report: Pathway to Global Product Safety and Quality it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority. Furthermore, 80 percent of the active pharmaceutical ingredients in medications sold here are manufactured elsewhere.
Placebo medications could be produced on an as needed basis. Their current regulation has the very real potential to endanger lives.