A Generic Post

In principle, I'm all in favor of saving money with no-name brands.

We do a lot of that in the grocery store. Our cart fills up with a lot of store-brand or lesser-known brands, every bit as tasty and we don't have to pay for all the advertising overhead!

Then again, there are exceptions. I happily eat the off-brand Crisp Rice (instead of Rice Krispies), packaged in the big plastic bag; JoyDad eats Mom's Best raisin bran instead of Post or Kellogg's. But I do not like the taste of off-brand Cheerios and Kix. Those two are not every-bit-as-tasty in the off-brand, I can taste the difference, and I'd really rather not buy/eat the inferior stuff.

There are some similar -- and much higher stakes -- issues with generic drugs too. In general, I'm all in favor. Health care costs are way-too-high, and generics can do their bit to help bring costs down. JoyDad and I avail ourselves of generics both for prescriptions and for over-the-counter meds.

Unfortunately, epilepsy drugs are a example of when generics aren't necessarily ideal. The FDA rules for generic bioequivalence allow for a rather suprising amount of tolerance around how well a generic version needs to match the corresponding brand name -- to make the cut, a generic needs to be reliably "within 20% above or below the blood level generated by a corresponding brand drug." When it comes to anti-epileptics, where the therapeutic dosage can be in a narrow range, that degree of difference between brand-name and generic (and possibly even more so between two different generics) can apparently be enough to mess with seizure control, to potentially disastrous results.

A recent article at Epilepsy.com has a nice round-up of recent research conducted on generic substitution for anti-epilepsy drugs, with a number of studies pointing in the direction that the differences may indeed be problematic.

There are a couple of different approaches underway to remedy this. A citizen petition was presented to the US Food & Drug Administration (FDA) in 2006 requesting that the agency address the issue of brand-name/generic substitution for anti-seizure meds. However, it does not appear that the FDA has responded substantively. More recently, in the conference report that came out with the funding bill for the FDA for the coming year, Congress has upped the ante by including the following request:

The conferees request the FDA report on adverse events and seizures associated with brand and generic anti-epileptic drugs. Specifically, the agency should examine the pharmacokinetic profiles of “A” rated anti-epileptic drugs from different manufacturers of the same therapeutic agent. The Committee directs the FDA to submit a report not later than September 30, 2010, detailing whether the agency believes that any changes to the current bioequivalence testing should be recommended.

(from FDA Law Blog)

Although -- the FDA is already on record with the belief that no changes need be made, so I'm not sure how this would impel any belief-changing (why is this about "belief" anyway?) Maybe if either internal or external evidence piles high enough, they might change the tolerance guidelines for this particular group of meds. I wonder if that's been done before.

Here in Wisconsin, there was also a push for a legislative remedy this past session of the state legislature. The bill (2009 AB 506/SB 354) would have required consent from both the prescribing physician and the patient/parent/guardian before a pharmacist could substitute generic for brand-name anti-seizure drugs, or substitute one generic for another. Wisconsin law already prohibits such a switch if the original prescription specified "no substitutions" -- and the opponents of the measure were quick to point this out. A public hearing was held, but it looks as if the bill died in committee, and never came to the floor for a vote.

As you might guess, we've had direct Joy-experience with this, two times this year now. We've been so fortunate to have finally hit the sweet spot with her meds combo, such that the scary-seizure days have receded into memory for a while now. One of her two meds has been generic from the get-go, but the other one began as a brand-name.

I knew about the substitution concerns, and so I was taken aback when I showed up for a refill at the pharmacy counter this past January and was told that our insurance wasn't covering the brand-name anymore, so they'd filled it with the generic. I pressed the pharmacist a bit, but he seemed to think that we'd be in for an uphill fight for reimbursement if we wanted to try to get doctor's orders not to switch. I went ahead and let them ring up the generic, and contacted Joy's neurologist, who said he didn't anticipate any issues with the switch. So we started in with the generic, and saw no problems, and so that chapter ended well except for being an extra worry in the back of the mind as we started in on that new bottle.

Well, here we are only six months later, and they've switched it again. This time it's from one generic to another. This time the issue was with our pharmacy's wholesaler, who suddenly made a complete switch to another manufacturer. The pharmacist was, once again, sympathetic. He had taken a continuing education session on just this issue (generics and seizure meds), knew the concerns... and couldn't do a thing for us. He did try, calling the wholesaler just to be sure that the other wasn't still available. I'm sure the pharmacist's boss wouldn't thank him for this, but he even suggested that we might want to call around and go to a different pharmacy if we could find someone else who carried it! Which we don't really want to do -- inconvenient at best, and who's to say the new pharmacy's supplier wouldn't pull the same trick in a month or two?

The legislation was well-intentioned, but I wonder it would really help either situation. It's aimed at the pharmacist, but he/she can't do anything about what our insurance will cover, nor (probably) about decisions at the wholesale level.

I dislike ending a politics-wonk blog post without a call to action. Sigh. Maybe just to think good thoughts for us as we crack open the new generic bottle, that all continues well with Joy's seizure control.