Good Thing Generics Were Elevated

October 12, 2012
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at

Applied Clinical Trials

So last month I posted about the FDA elevating the Office of Generic Drugs to reflect that segment of the industry’s importance in CDER. It now reports directly to Janet Woodcock. It also now gets to put user fee dollars into GDUFA, the equivalent to PDUFA.

But no, there is no equivalence between PD and GD apparently. In either a pre-emptive move or a real concern that generic prescriptions now account for almost 80% of all prescriptions in the US, that announcement seems prophetic now. Prophetic or calculated based on the FDA’s early October announcement that it had discovered budeprion XL 300 mg, manufactured by Impax, marketed by Teva, was not therapeutically equivalent to the reference drug. That drug is Wellbutrin 300 mg, which is prescribed for major depressive disorder (MDD) and for the prevention of seasonal affective disorder. Impax decided to withdraw the drug.

There are a couple of issues that stand of for me in this blog that were posted on this topic from Forbes:

  • The FDA received final results on the efficacy issue to budeprion in August, which is quite near to the time that the Office of Generic Drugs was elevated within CDER. Prophetic or calculated?

  • The determination of bioequivalence for the 300mg dose was actually never studied by Impax, and waived by FDA based on safety reasons. Rather, the data from the 150mg was extrapolated and used for its approval of bioequivalency. As we know with the generic forms of biologics or biosimilars, they aren’t equivalent, they are similar.

I envision some downstream effects from this announcement. Central to what the Forbes blogger was mentioning about the effect on patients. What I see is a general public that is either assured by a pharmacist, physician or the individual’s health plan that generics are just lower-priced copies of the original. They are “just-as-good.” But here, we see, they may not be just as good. In fact, a doctor recently told me to take a brand name of a drug because the generic may be inferior.

I think health plans and formularies may have a hard time explaining why all their customers want the “real” drug. Or we will just shoulder the costs and pay the higher amount so we can get the “real” drug. This is worse than shopping online for drugs. Because the public assumes that it’s OK. They don’t understand the minutae that is the FDA or CDER for that matter.

CDER has recognized the issue and responded by elevating the Office of Generic Drugs.

As @ivsin pointed out to me, bioequivalence drugs are considered Phase I. That is why the FDA did not require Impax do the maximum dose study as it feared seizures in the healthy volunteers. It accepted the extrapolated results. The FDA fact sheet on the withdrawal does not document how the Office of Generic Drugs will address its next steps in the big picture.--if it will change policy, requirements, etc. Especially on the heels of the compounding issue and no FDA oversight over the compounding pharmacies in the meningitis crisis--There is some kind of huge learning cloud over the FDA right now.

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