More on Generics, the Pipeline and Communications

J0400287 There has been a lot of news about generics lately.

There are approximately 75 brand name drugs scheduled to go off-patent over the course of the next two years.  Last week, the highly lucrative statins saw the first generic among their ranks. 

If you couple that with the fact that the production of new drugs from the pipeline has shrunk, it would appear that the stage is set for a medical deflation in pharmaceutical pricing.  With more generics on the market, costs will go down.   With fewer new drugs on the market, the only reason for the overall price of drugs to go up is if manufacturers raise prices to account for the fact that there are fewer brand names on the market. 

I’m not a market analyst, but from a public affairs perspective, if the prescription drug price inflation were to disappear, it might not be a bad thing for industry.  It would cause a lot of the pressure for importation and price controls to ease.  The overall public image of pharmaceutical companies might rise, or at least stop falling. 

However, the stage does not appear to be set for progress at the FDA.  As Marc Kaufman reported in the Washington Post the FDA is seeing a backlog on generic applications and had no plans to increase its capabilities in this area.  Since this flies smack in the face of good public policy, look for more on this in the coming months.

Another consequence of patent expiration is the increased potential for drugs to move from RX to OTC status.  More on that tomorrow.

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3 Responses to More on Generics, the Pipeline and Communications

  1. Ed Vawter says:

    A Tufts report released today says that the number of clinical trials is increasing.
    It claims a 52% increase in clinical trials for new compounds from 2003-2005 and cites this as evidence of the R&D pipelines starting to recover.
    I haven’t necessarily seen that and wodner how they counted trials. A trial to for a new indication for an existing drug doesn’t really count as a NCE in my opinion.

  2. Mark says:

    Thanks and yes, I just saw the news of the report this week. Perhaps it is worth comparing POVs on this and compare the reports that it is slowing down to this report and discerning the difference.

  3. Dan says:

    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.
    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

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