With our new administration, this is getting to be real heated topic and everyone has their points.  Right now with some medications not having a generic equivalent, patents are being challenged to bring a generic to market sooner.  One of the oldest methods used for years has been to –re-invent a drug with a time released formula to extend the patent timeline. 

This case is interesting in the fact that for 3 weeks a generic equivalent was on the market and cost someone his job at Bristol.  Existing patents are being challenged by generic manufacturers and in some cases just because the opportunity is there, they can right now in the hopes of providing a cheaper, less expensive drug if they are successful with the challenge.  In a related story, Merck and Teva are going through a similar situation with Singular’s patent being challenged.   

In addition, there’s the heated battle over Bio-Similar drugs facing Congress. 

“The terms "Biosimilar" or "Follow-on Biologic" refer to products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Due to the complexity of biologics, a product can only be made that is similar, but not identical.”

Plavix also has some heat coming from another area, medical devices in clinical trials to use to thin blood, so another area of potential competition.  The NIH is also funding a study with generic testing to determine if this information will lead to better treatment plans with Warfarin, the generic blood thinner.  We have also had statements made indicating such studies are not “cost effective” in all areas, with the risk management side chiming in.

Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?

Will Plavix itself be subject to genetic testing and what effects does the drug have on kidneys and the liver?  Patents, genomic testing and competition from potential medical devices certainly leave a lot on the table for discussion with Plavix, not to mention lawsuits that are intermingled, and what does the FDA recommend for labels?  It is time for a “reboot” here? 

Scientists gather to chart out a 'total reboot' for medicine – Science and Medicine Coming Together

Between the marketing battles, generic information unfolding, studies, device competition, labeling with the FDA, and last but not least the patent issues, where is is all going to end up as it’s a very complex and confusing matter.  BD 

Bristol-Myers Squibb is paying $2.1 million to end the FTC probe into its negotiations to delay generic competition for Plavix, the company’s blockbuster blood thinner. Those 2006 negotiations were something of a debacle — a generics maker wound up briefly flooding the market with generic Plavix, and the Bristol-Myers CEO left the company.

Earlier this year, the FTC sued a company called Solvay over a generics deal regarding AndroGel, a testosterone product. (The company said the deal was lawful and would lead to earlier generic competition.) And last year, the FTC sued Cephalon in a similar matter involving the anti-drowsiness drug Provigil. (Cephalon says it followed the law.)

Regulators Cast Wary Eye On Deals to Delay Generics

Genomics Related Reading:

Personalized medicine will rely on IT – It’s all about Software
Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?
Genetic warfarin test not cost-effective in guiding initial dosing of common blood thinner

Plavix – What’s the next step for doctors and patients – possible genetic testing in the near future?

Who's going to pay for the Warfarin Test - Personalized Medicine
Genetic Testing Improves Some Warfarin Dosing

FDA To look at benefits of Plavix in certain patients

FDA Approves New 300mg Loading Dose Tablet For PLAVIX(R) (clopidogrel Bisulfate)

2 comments :

  1. Often when one goes to seek medical attention from a health care provider, that provider usually writes a prescription for that patient for medication to either treat the symptoms of the disease that may be present.

    Or, the health care provider may actually cure the disease, as with the case regarding antibiotics.

    Also, the provider may prescribe medications to delay the progression of a disease that may exist with their patient.

    The actual cost of that medication the patient receives from a pharmacy can vary greatly, and here is why:

    More now than in the past, generic medications have been encouraged and selected by prescribers at a much higher rate.

    Health care providers are aware that generic drugs are less expensive than branded drugs that are equivalent to the generic drug prescribed as far as safety and efficacy are concerned.

    Nearly two thirds of all medications prescribed to patients in the United States are now for generic medications.

    Generic medications are bioequivelant copies of branded medications that previously existed, yet no longer have a patent on these medications, which allows generic drug companies to produce these formally expensive drugs and a much lower cost.

    Why aren’t generic medications prescribed all the time, then?

    The branded drugs have their company sales representatives who leave samples of these branded medications with the health care provider, with the intention and belief that this provider will select this branded drug as a result.

    Generic medications, while much less expensive than branded medications, do not have samples of these drugs to be left with health care providers.

    Around 4 billion prescriptions filled every year, so cost savings is rather important.

    Generic medications are about two thirds of this total pharmaceutical market with the drugs included in this market.

    However, while most prescriptions are for generic medications, this still is less than 15 percent of the total money spent on prescription drugs.

    With branded medications, about 75 percent of these newly approved drugs by the FDA are similar in efficacy as drugs that already exist in this market, so there is no benefit with many of these expensive branded drugs.

    Roughly half of all newly approved prescription drugs have had serious side effects soon after they have been approved, so newer is clearly not always better, of course, as it relates to safety for the patient taking the drug.

    Most recently, certain managed health and prescription providers have been actually paying doctors to initiate if not switch their patients from branded medications they may be taking to generic medications, if possible.

    This may be due to a reaction caused by branded pharmaceutical companies offering similar inducements to health care providers to select their promoted medications.

    Both financial inducements that occur are remarkably legal, overall. Yet I find financial inducements in health care inappropriate and unethical when a health care provider treats a patient with prescribing medications for them.

    Not long ago, generic drugs 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 clinical trial protocols as branded meds.

    Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced.

    This Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer.

    So nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA.

    This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical market, and doctors started prescribing more generic meds as a result.

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  2. Fast forward to 1984, as this is when the Hatch-Waxman Act was introduced.

    This Act only required generic meds to demonstrate bioequivalence to the branded med that they desire to reverse engineer.

    So nothing else was now required in the approval process that is mandated by branded medications to be completely developed and approved by the FDA.

    This reduced cost of generic manufacturing and approval allowed for more of these meds to saturate the pharmaceutical 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 some drug companies devised schemes to extent the patents of their branded meds through such tactics as altering their existing branded medication by combining it with another generic drug from another class of medications.

    This tactic is referred to as evergreening, and the tactic extends the patent life of their branded drug of concern.

    Additional branded drug company tactics include frivolous patent infringement lawsuits, which delays generic availability for a longer period because of these lawsuits.

    Also, branded pharmaceutical companies have been known to actually pay generic manufacturers to not release the equivalent of a branded medication they wish to continue to promote.

    The pharmacies that fill the prescriptions for the patients written by the health care providers support generic use, as pharmacies make more money off of generic prescriptions they fill for others compared with branded drugs.

    Generics seem to remain a concern to branded companies in spite of their efforts of avoiding their access into a market they believe to own.

    Recently, branded pharmaceutical companies have either purchased smaller generic drug companies, or have started to produce generic medications on their own.

    This is due to the progressive impact generic drugs are having on the business of branded drug companies.

    Also, other reasons for increased generic prescribing may be due to the awareness and clinical experience of the previous branded med that has now been replicated by the generic medication.

    Again, newer drugs at times are not a desirable choice of treatment for patients because of understandable concerns by the prescriber.

    One particular concern is safety that has not fully established with a new medication.

    The familiarity of the generic drug accessible to them after the patent expiration of a branded medication the prescriber has utilized often in the past with treatment success for their patients allows the prescriber to utilize the generic equivalent not that it is available often.

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