A Comment About

Smothering Medical Innovation

April 2, 2011 - 12:06 am - by James V. DeLong
Dr. Dave
2011-04-02 10:35:33

This is an excellent, well written piece. Proprietary prescription drugs follow one of two pathways in this country. Eventually the patent runs out and they all become generic. Some fade into obsolescence while others inexplicably hold on. One pathway is the journey to OTC status. Magically, they’re only “safe enough” for OTC sale AFTER the patent has expired. Some examples include ibuprofen, naproxen, cimetidine, ranitidine, omeprazole, loratadine, fexofenadine, etc. Once generic manufacturers can produce generic versions of the “Rx Only” medications, the brand name manufacturer releases their proprietary version OTC and is granted market exclusivity for a period of time to wring all possible profit out of the drug and the brand before generic OTC manufacturers enter the market. The reason these drugs were available as “Rx Only” until the patent expired is because that’s where the money is. The pharmaceutical manufacturers have more latitude in what they charge to a 3rd party payer. Further, insurers pay for Rx drugs but seldom for OTC medications. When these drugs are first released as branded OTC products the price to the consumer is almost always significantly greater than the price to a pharmacy for an “Rx Only” labeled generic version. The reason (i.e. excuse) given for this is that the brand name manufacturer jumped through all the necessary hoops with the FDA to obtain OTC approval and are therefore rewarded with extended market exclusivity. Other drugs (e.g. albuterol inhalers) are remarkably safe yet remain Rx Only largely to protect physicians’ interests. The specious argument offered up is that patients might self medicate symptoms that would indicate a more serious problem to a physician. This is a load of crap. The very same thing can be said of ibuprofen or omeprazole. The regulations are “adjusted” to meet the demands of the various special interests. The big fear is that if albuterol inhalers were to become OTC, insurers might not pay for them anymore. The horror! Patients having to pay for their own medications.

The other path is for the brand name Rx Only product to become a generic Rx Only product. Over time the price really drops. A pharmacist described to me that with their contract pricing, a 30 day supply of some of these drugs cost less than the vial he puts them in. The generic manufacturers base their unit price on volume. Lisinopril just became generic within the last decade or so yet pharmacies go through tons of it so the generic price is cheap. Spironolactone has been generic for over 25 years. It is still an important drug but considerably less is used, therefore it is considerably more expensive.

What annoys me is that the US consumer subsidizes the rest of the world by paying for the R&D for new, proprietary drugs. Generics should cost the same in Canada and Mexico as they do in the US (especially if they’re made in India or Israel). Canada and Mexico (and everybody else) should pay the same for new, innovative, proprietary drugs as well. But this is the reason that all of the UK’s drug concerns have all their research facilities in the US. The US consumer pays for their R&D and then they can sell the drugs back to their NHS at a discount.

Aside from all the protectionism of special interests, questionable regulations, lopsided marketing and inherent unbridled avarice, pharmaceuticals are still provide the most bang for the healthcare dollar. Along with the surgeon and the dentist…the drug actually DOES something for your health.