Replies to post #2639 on Biotech Values

[rph_in_wi]

Generic Debate

As a pharmacist who has been working with generic drug substitution policies for many years, I see the benefits to our healthcare system that most generics have brought. Having said this, you must understand the requirements for an approved generic and the areas of physiology where the parameters for approval are not strict enough to ensure true bioequivalency.
In simple terms, the FDA allows for a +/- 20% variation in blood levels from brand to generic. The FDA states that the human body can not sense the difference of a 20% variation. In reality, the last time I checked, the average variation for submissions was ~4-5%. Unfortunately, most doctors will tell you that there are some drug classes (hormones, seizure meds, others) that are dosed so specifically that even a 4-5% swing may be enough to cause some untoward effects. Synthroid has always fallen under this umbrella.
I think this is why there is some very appropriate caution being used by professionals today regarding the rampant substitution that will occur in every pharmacy in America. Think about it logically. Why are there 12 different doses of Levoxyl, most dosed within 12.5mcg of each other! Small variations can matter!
Just my cautious two cents.
RPh

[DewDiligence]

Re Generics:

As rph and biowatch noted, Synthroid/Levoxyl is an atypical case.

If it were up to me to make policy on generic drugs, I would consider these revisions:

1. Eliminate or curtail extensions to marketing exclusivity when the first patent on a drug expires but other patents remain in force.

2. Reduce (or eliminate) existing statutory patent extensions for 50% of the time a drug is in clinical trials. (I would retain the 1:1 patent extensions for the time a drug is undergoing FDA review.)

3. Do away with the mandatory 30-month delay in a generic launch when a patent is litigated.

4. Abolish exclusivity from patents on isomers or metabolites of a drug that extend beyond the term of exclusivity afforded by the patent on the parent compound.

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These ideas are somewhat “raw” and fine-tuning may be necessary to make them practical. However, the general idea is that I would favor an increased role for generic drugs in the overall provision of healthcare. Regards, Dew