Senate to Debate Big Pharma Deals with Generics
One of the big topics recently has been the deals that some large pharmaceutical companies have struck with smaller generic firms to keep the generics off the market.
Senate bill aims to end deals that slow generics - Yahoo! News:
The article talks about the Senate plans to ban the deals made between brand name pharmaceutical companies and potential generic makers. This allows the brand name to continue making large profits and sometimes the generic maker makes more money in the short run than they would have made otherwise.
Here is a quote from Partick Leahy (D-VT)
“Congress never intended brand-name drug companies to be able to pay off generic companies not to produce generic medicines,” Leahy said at a Judiciary Committee hearing. “That would be a shame, harmful to consumers, and a crime.”
What is interesting is the increase in the number of such deals. In 2005 there were seven such deals; in 2006 that doubled to 14. Also recent court rulings such as an appeals court in Atlanta brought by the FTC about Schering-Plough illegally keeping a generic version of its K-Dur off the market were ruled against the FTC and for the pharmaceutical company. The US Supreme Court declined to take up the case. Another lower court also threw out a similar case involving Tamoxifen from AstaZeneca.
What is interesting is that some companies in the generics industry have come out against it also. The chairman of Barr Labs, Bruce Downey said the proposed bill;
will discourage vigorous challenges of patents because generic companies will lack the flexibility to settle some cases once they are filed.”
“The proposed bill therefore would undermine the incentives Congress has carefully created to promote generic competition,” Downey said.
I don’t know that I agree with that statement. His statement, to me, implies that sometimes the generic drug companies may really not have a case but it is a way to make the big pharma company pay them even if the generic company might not have a solid case. I think the purpose of the government incentives was to manufacture cheaper generic drugs, not to make money off of big pharma from stifling of competition.
The Pharmalive article covers the recent testomony of Federal Trade Commissioner Federal Trade Commissioner Jon Leibowitz . He said that the recent court rulings I mentioned above have made it more difficult for the FTC to proceed with antitrust cases in order to stop exclusion payments.
The Pharmagossip blog also recently had a posting on this topic.
PharmaGossip: Big Pharma payoffs to Generics companies - “somewhere between bribery and extortion”:
This posting is actually part of an editorial recently in the Star Ledger and can be found here. Given the number of really big drugs coming of patent in the next 4-5 years this practice is sure to get more lucrative for the generic drug makers and occur more frequently. It will be interesting to see if this gets through Congress and even then it will almost certainly face a presidential veto. This will be a interesting topic to cover in the coming months.
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May 30th, 2008 at 9:12 am
The Benefits of Generic Medications: Is the Efficacy There?
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