Health Populi

Monday, March 17, 2008

The golden era of generic drugs


This is how IMS recently referred to 2008 and the next phase of the pharmaceutical drug market.

I recently posted here a pharma market update on drug prices (up), DTC (working), and generics ("the un-detail").

Here's the PS for that post, brought to you from IMS, the prominent market research firm focused on pharma. In their latest report on the industry released on March 12, IMS has found that last year's 3.8% growth rate was the slowest since 1961.

Generics are now more prominent in the U.S. health scene than branded pharmaceutical drugs. The total U.S. market for prescriptions is valued at $275 billion retail. By 2007, generics' share of that total rose to 65% from 47% in 2001. But while they make up 2 of every 3 pills prescribed, they account for only 20% of drug spending. IMS data show the generic drug segment is growing 13 to 15% a year by volume -- much faster than branded meds.

At the same time, as I reported in my post on pharma earlier this month, branded pharma products will lose even more patent value by 2012 -- as much as $18 bn.

Investor's Business Daily published an excellent analysis of IMS's data.



Health Populi's Hot Points: For consumers, in the short run, the lower price of generics feels like a very good thing for the pocketbook. For manageable conditions like allergies and hypertension, that's terrific. But IMS issues a warning with which I agree: "If you don't have a new brand, you can't have a copy of it." IMS expects that the current "innovation drought" could result in a "generic drought" within about six years. That's not good news for anyone. A rich pipeline with new-new pharma products is what's good for the public, and we don't have that today. Generics' "golden era" is thus limited by branded pharma's pipeline. What would Dr. Kildare and Ben Casey, the two Top Docs of TV in 1961, think of this situation? No Bonanza for patients, that's for sure.

2 Comments:

  • This report clarifies that pharma needs to focus more on innovation and less on marketing and expensive, branded me-too drugs.
    We shouldn't lose site of the fact that good, cheap generics still have a long way to go. Life saving drugs such as statins are still quite underutilized in the U.S. and even less in poor(er) and developing countries.

    By Blogger ireynoldsss, At March 19, 2008 8:47 AM  

  • The Benefits of Generic Medications

    More now than in the past, generic medications have been encouraged by prescribers at a much higher rate due to the problem of the high cost of branded meds that many find unfair and unreasonable. Branded meds are still prescribed often, though, mainly due to samples of such meds provided at a doctor’s office from the sales reps who promote these meds. Generics typically are not sampled due to lack of funds compared with branded pharmaceutical companies. Yet generics cost a small fraction, such as a third of the cost, of the same branded meds that have the same molecular bioequivalence. Yet not all branded meds have a generic formulation due to patent exclusivity and therefore cannot be produced until the expiration of this patent of the branded med. This is further complicated by possibly a degree of apathy with health care providers, who appear largely demoralized with aspects of the U.S. Health Care System. More likely, however, is that samples do, in fact, help out the patients.
    Not long ago, generic meds were not prescribed that often, or produced to a great degree because of the cost of bringing such a med to the market, which at the time required the same protocols as branded meds. Fast forward to 1984, when the Hatch-Waxman Act was introduced, and this Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer, and nothing else included in the approval process. The reduced cost of generic production allowed for more of these meds to saturate the market, and doctors started prescribing more generic meds as a result. Branded pharmaceutical companies were not pleased in large part with this new act, so they devised schemes to extent the patents of their branded meds, through such tactics as reformulation, which is called Evergreening, of their meds and frivolous patent infringement lawsuits, which delay generic availability for a longer period. Yet pharmacies support generic use, as they make more money off of generics compared with branded meds. So delays will not prevent the utilization of generics, overall. Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access, as branded companies have progressively started producing their own generic meds along with their branded ones due to the increased use of generics.
    Also, other reasons for increased generic prescribing is due to the awareness and clinical experience of the previous branded med that has been replicated by the generic med. Newer drugs at times are not a desirable choice of treatment for patients because of lack of confidence- safety being the main concern with some prescribers. So the familiarity of a generic equivalent of a known med creates a more reassuring choice for the prescriber. Available generics are listed in what is called an orange book. It should be available to all health care providers for their access.
    Most encouraging for even greater use of generic meds is that at least one company has created vending devices for doctor’s offices for dispensing both generic and over the counter meds. This may discourage the use of branded equivalent meds at a greater amount with generic samples available as well as the branded meds. In addition, and in some cases, doctors can order generic samples from the manufacturers. Knowledge is a good thing.
    Yet some doctors insist that you get what you pay for, so they are convinced that branded meds are always more efficacious and tolerable than generic meds. This misconception is a fallacy, since both forms are identical from a bioequivalence and bioavailability paradigm, as required for approval. I’m sure it’s possible others have encouraged such doctors to take such a stance void of fact and reason. Yet there may be some truth to decreased efficacy of generic meds over their branded equivalents.
    Considering the health care crisis in our country and the over-priced treatment methods in our system, as with branded pharmaceuticals, generic medications should be considered when clinically appropriate for the benefit of those seeking restoration of their health. It would beneficial for patients to become aware of this pharmaceutical system and request generics when being prescribed a med by their health care provider. In other words, they should question authority figures such as doctors are perceived to be, as patients definitely have a right to acquire knowledge and use this for their benefit with situations as their choices for treatment options, as this will be for their financial benefits while improving their well-being with generic medications- an ideal way to reduce health care costs and improve compliance with their meds because generics are an affordable asset to public health.

    “What good fortune for those in power that the people do not think.” --- Adolph Hitler

    Dan Abshear

    By Anonymous Anonymous, At May 28, 2008 4:11 PM  

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