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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on November 28, 2009, 07:06:15 PM
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Biotech bills give drugmakers too many years of exclusivity
November 24, 2009
THE BIOTECH INDUSTRY is vital to the Massachusetts economy and the complex drugs made by companies here deserve robust protection as intellectual property. But giving exclusive markets to those companies for too long means that the drugs are priced beyond the reach of some patients for years - and it only adds to the upward pressure on health care costs.
Expensive biotechnology drugs - typically made from living cells - cost patients and insurers billions of dollars a year even as they treat intractable illnesses. Congress has tried admirably, in pending legislation, to open the door for approval of generic versions of drugs known as biologics. But, after intensive lobbying by the biotech industry, the measures that are emerging from Congress grant too many years of exclusivity to the original makers. Provisions in the House health care bill and in a bill approved by the Senate Health Committee would not allow generic imitators of biotech drugs on the market until after the original drugs have been on sale for 12 years.
That’s too long, more than double the five years of protection from competition guaranteed for conventional drugs. It’s quite likely that extensive lobbying accounts for some of the disparity; The New York Times recently reported that lobbyists for the biotech firm Genentech ghostwrote parts of official statements made by 42 members of Congress on the parts of the health care reform bill related to generic biotech drugs.
The 12-year protection is also excessive because competition from generics is not likely to erode the ability of the original biotech manufacturers to continue reaping profits. There are onerous technical barriers to making so-called biogenerics, unlike generic versions of conventional medications, so companies that invent original drugs are likely to retain market share despite the new competition. In Europe, where a path for approving generic versions of biologics already exists, the original drugs’ prices have dropped only by about 25 to 30 percent, according to the New England Journal of Medicine.
The downside of this, of course, is that approving generic versions is unlikely to eliminate the drugs’ annual five- and six-figure price tags anytime soon.Yet even modest savings add up. Medicare spends more than $2 billion per year on just one biologic drug, Epogen, used to treat anemia in kidney patients. The Congressional Budget Office estimates that the government could save more than $9 billion over the next decade if biogenerics come on the market after seven years. The long-term savings would be even greater.
In clearing the path for generic alternatives to expensive biologics, Congress should enact a shorter window of market exclusivity than 12 years, but more than the five years afforded to simpler, conventional drugs. A protection period that falls directly in between these extremes would strike a balance between encouraging companies to make biologic drugs and making them affordable.
In this case, what’s optimal for Massachusetts drug firms is not good for the nation or for suffering patients. A compromise is necessary.
http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/2009/11/24/biotech_bills_give_drugmakers_too_many_years_of_exclusivity/
READER COMMENTS (27)
IDIKO wrote:
BIOTECH INDUSTRY are made up of CROOKS and VAMPIRES masqurading as SAVIOURS, there will be no protection for these digusting people. What of RUMSFELD DIRECTORSHIP and SHAREHOLDERSHIP in most of these so- called BIOTECH FIRM. How could a WAR CRIMINAL be protected , it is only when these firms start kicking booties of the UNHOLY MESSIAHS amongst them, can we talk of " PROTECTIONS".
11/24/2009 6:28 AM EST
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ando21133 wrote:
It is noteworthy that in June the Federal Trade Commission issued a report concluding that no additional market exclusivity was needed for biologics due to the high barriers to entry of biosimilars, even higher barriers to market entry of subsitutable biogenerics, and limited anticipated price competition.
FTC's press release announcing the availability of and briefly summarizing the report is available at:
http://www.ftc.gov/opa/2009/06/biologics.shtm
The complete FTC report is available at:
http://www.ftc.gov/os/2009/06/P083901biologicsreport.pdf
11/24/2009 6:32 AM EST
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XENOPHONIC wrote:
If a company doesn't have an incentive for 'exclusivity' why should one bother spending millions if not billions on R & D and the endless clinical testing if only to lose their exclusivity at the whim of hack politicians?
11/24/2009 6:46 AM EST
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detmolders wrote:
ando21133 is correct. There is no need for added exclusivity for biologic products because the difficult path to licensure confers its own exclusivity. There will never be generic biologics in the same sense as generic drugs, no matter what any legislator thinks or wants.
11/24/2009 7:35 AM EST
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rtwngr wrote:
As an MS sufferer who can walk only because of breakthrough drugs from companies like Massachusetts' own Biogen, I take strong exception to this editorial. Had Biogen not been assured of exclusivity they may well not have developed Avonex, an expensive immune system modulator that slows MS. So successful was this drug that many competitors here and abroad have tried to infringe on their patent. When one considers the many serious and chronic diseases that on the cusp of being cured or neutralized by US drug makers, removing their protection would be counterproductive and possible catastrophic.
11/24/2009 7:42 AM EST
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frenzee77 wrote:
These types of drugs are much more difficult to make. If there wasn't the extra exclusivity then the incentive to make them would be gone. The companies that make the generics don't have to go through all the same rigorous testing that the inventor has to go through. One clears a path for the other. It only takes about 2 years to get a generic approved as opposed to the 8-10 years of research and clinical trials. You don't think there will ever be generic biologics? Genzyme already has two competing companies going after their market share for Gaucher disease. If they could have made a generic drug they would have done it.
11/24/2009 7:57 AM EST
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btheredthat wrote:
Thanks, ando21133, for the FTC report, it helps explain (albeit in 70 pages of text :) (the ExecSumm is helpful enough) a very complicated issue. In something like this there's enough evidence to "prove" both sides of the question, but the more info the better.
11/24/2009 8:10 AM EST
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We removed Johnodog's comment.
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dcarlo wrote:
If the period of exclusivity were to be raised, I think seven years rather than 12 years would be the appropriate time for exclusivity. Public Citizen, an organization that publishes "Worst Pills, Good Pills News" recommends taking no new drug until it has been on the market for seven years. The reasoning behind that recommendation is that in seven years, and side-effects or any adverse result from taking the medication will be known and investigated.
11/24/2009 9:11 AM EST
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redbarchetta88 wrote:
How much money does a company have to spend in order to develop drugs? Even with R&D grants available typical medications cost hundreds of millions of dollars to develop, and most drugs fail to cover costs. Exclusivity helps companies try to recoup costs, much like a patent. The government would have to subsidize drugs even more if exclusivity if reduced or eliminated as some radicals propose, which is a bitter pill to swallow for some.
11/24/2009 9:11 AM EST
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mollydingle wrote:
This measure was strongly endorsed by the late Senator Kennedy. In fact, it was due to his efforts that the exclusivity was increased to 12 years. This was in exchange for additional donations to his library/educational center.
Strange that the Globe barely noted it at the time, but with the Senator safely in his grave and health reform tanking it's suddenly an issue.
11/24/2009 9:39 AM EST
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Barry1Roberts2 wrote:
Once again the hacks in a declining print company (Boston Globe) show their bias and contempt for an innovative industry (Biotech).
11/24/2009 10:15 AM EST
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ericsiverson wrote:
the exclussiion contract can be extended for another 7 yrs like for seed cos . selling biotech seed . Argentinia and Brazil planted the seeds without paying the tech fees . but the international corperations refused to load the grains on the ships untill the tech fees were paid . Now the tech fees can go as high 75 dollars acre for biotech seed and sometimes 25 dolllars for patent rights on the herbicides for weeds .
11/24/2009 10:27 AM EST
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BAMDAD118 wrote:
Once again the Globe comments on what they know nothing about, not that the facts will ever get in the way.
They have that exclusivity because it costs almost $500 million dollars to bring a new drug to market, that doesn't take into consideration drug costs that the product fails or doesn't make it to market. The liability costs are astronomical and you would not incent anyone to come up with new drugs if you didn''t give them that window.
Hey Globe, why don't we force you to have conservative views on your editorial board, cut back on the amount of liberal pablum you try and force feed to everyone every day. Oh wait, the rules are for the other people.
11/24/2009 10:49 AM EST
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Barby414 wrote:
OK -- I vote for 9 years - yes it is totally arbitrary --but so what!!!! Like Big Pharma is going to be hurt.....tell me again, how much money they spent annually each year (last 5) specifically on 1) advertising & 2) donations to PACs & individual politicians....and yet they are crying.
11/24/2009 11:07 AM EST
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m1chael0 wrote:
I like where the Glopbe is going on this one. This is a very progressive idea and I think it is brilliant!!! We should take all the financial incentives out of drug discovery and development. The best way to do this is to nationalize the drug industry. We should also incentivize the scientists by allowing them to unionize. How better to ensure innovation and efficiency by having all new ideas and methods for devloping drugs coming from union labor. We can use the MAss model of union dominated labor. I can see it now!!! A scientist sitting at his bench, staring into a test tube while driniking his Dunkin' Donuts coffee and talking on a Cell phone. Also, we can have scientist that report to the lab just to sleep for two days, so that they can be well rested for there other under-the-table job. With this system we will have so many effective cheap drugs that we will all live forever or at least until we run out of other people's money!!!
The USSR was so successful using this model - remember all the great drugs they developed? Well ok, but we in the USA are better than them, and we can prove big government can work. Thank you Globe for remaining consistant.
A wise and frugal government, which shall leave men free to regulate their own pursuits of industry and improvement, and shall not take from the mouth of labor the bread it has earned - this is the sum of good government.
Thomas Jefferson
11/24/2009 11:08 AM EST
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rtwngr wrote:
Looks like everyone blew part my real world experience in favor of the usual partisan sloganeering. Yes, those evil Big Pharma companies need to be stopped - creating jobs, saving lives, paying dividends to shareholders, etc.
11/24/2009 11:46 AM EST
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WVW wrote:
BAMDAD is on the right track. There is a very high fixed cost to bringing any pharmaceutical product to market. The drug companies simply base their pricing models according to projected unit sales and initial costs to make money over the exclusivity time frame. Shortening the time frame will only cause them to raise the prices to make their money over that shortened time frame. What is critical to accomplish if we are to contain drug prices is lower the costs of bringing drugs to market. That alone will lower prices and foster some little bit of competition to the process. The ridiculous FDA procedure needs to be streamlined and overhauled. The egregious practice of taking two "post-patent" drugs and combining them in one pill with a new patented time span needs to be stopped now. (hello vytorin) Also, the billions spent on direct to customer advertising needs to go back to being banned. This has bloated the costs of the entire industry which just means higher prices passed on to consumers, as well as spawned a whole generation of supposedly informed people bullying their doctors to prescribe stunningly expensive medicines that are no more effective than prior generation generics at 1/10 the price.
11/24/2009 12:14 PM EST
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JimDwyer1 wrote:
This article is outrageous -- cancel my subscription.
Wait -- I already did that because of this type of drivel.
11/24/2009 12:33 PM EST
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57-States wrote:
For every drug that comes to martket the drug companies spend billions of dollars in R&D. The R&D costs are recouped by the high margins on the manufacture of the drugs.
In the end if you shorten the time of exclusivity you will lower the cost to the consumer. The side effect is that drug companies will spend less on R&D and develop fewer drugs.
11/24/2009 12:35 PM EST
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waltjones wrote:
maybe shortening the time frame would give the drug companies some incentive to stop the very costly nos stop barrage of advertising prescription drugs on TV. Maybe they would even spend a bit more on real breakthroughs, instead of concentrating so heavily on copycat drugs for such medical scourges as erectile dysfunction. I think not, because their concern is profit above all, and only the fools like Bamdad believe that there is a concerted effort at bringing real help to people at great cost to the companies.
11/24/2009 12:40 PM EST
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CorinneAM wrote:
One point not addressed by this editorial is the public funding of scientific R&D.
The government, either through NIH or universities, funds much of the early clinical trials. The most risky trials are Phase I and II trials. The most expensive discovery trials are Phase III trials, which aren't as risky. Phase IV trials occur after products are on the market.
Much research on biologics benefits from extensive federal support from the public and non-profit sectors, especially in the most risky stages of development. Industry provides the most important source of financing for the later stages of research, particularly for post-marketing studies.
The public already has a significant investment in these drugs, at the most risky stage when they could either succeed or fail; in that light, a 12-year exclusivity provision is even more indefensible. When does the public get to "recoup" the investment on their tax dollars? Is it in the public interest to force someone to decide between paying the monthly mortgage vs. a month's worth of medication? Between paying for a year's college tuition vs. paying for a drug that may offer another year of life?
People are going into debt just to stay alive. Twelve years of exclusivity to recoup an investment made when risk is low is not in the public interest.
11/24/2009 12:50 PM EST
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Johnodog wrote:
I agree with CorrineAM, I just think we should apply this logic to other areas. I mean we pay to go see movies, right? and we buy popcorn? Those Theaters are using the roads we paved with public money and using the phone system we helped to install with federal help. Whe can we expecta cut of movies revenue that we are due? I also think the redsox should becomea public team. Certainly we have invested enough time and money over the years and have put up with traffic, so when can we expecta cut? Soon I hope. I mean people are going into debt just to see a ball game and is that fair? Isn't baseball the American pastime? That means we have a right to see these games. I do disagree with your analogy of choosing between medicine and College. because it sounded like you were implying College is expensive. I disagree, even though it outpaces inflation by 6% and tuition costs have tripled over the last decade, that doesn't mean these schools are making a profit. I can't wait for the Government to take more stuff away and give it to people like me with an unabashed hand sticking straight out.
11/24/2009 1:33 PM EST
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aldohux wrote:
Legalize marijuana and big pharma goes DOWN!
11/24/2009 2:08 PM EST
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Newtster wrote:
The Globe is concerned that 12 years of exclusivity contributes too much to rising healthcare costs, whereas 7 does not? The cost of pharmaceuticals is high because they cost WAY too much to develop thanks to an overzealous FDA. Of course if the politicians did not have the FDA at their disposal, how could they shake campaign "donations" from the drug companies? If not for regulation, who would need people from the industry to lobby politicians at a generous salary? How are FDA regulators going to attract a decent wage from the drug companies or lobbyists if there are not enough regulations?
snacks01 wrote:
How about the whole story? The 12 years of patent protection applies only to so called orphan drugs. They are drugs that treat diseases that affect a small number of people in the entire work. I’m not totally sure but something like less than 10,000 people. Without extended patent protection no company is going to spend $400-$500 million it costs to take a drug from idea to FDA approval. Then you usually have to build a separate facility to produce the drug. Now should a drug cost $100,000 a year to take, probably not but when you make 10,000 does a year that is not a lot of payback.
Also there is no exclusivity on the disease. Competing companies are free to make their own drugs that teats the disease. They just can infringe on the patent of the first company.
11/24/2009 5:30 PM EST
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Barry1Roberts2 wrote:
CorrinneAM, you are wrong. Industry pays for the bulk of clinical development including the early phase I, II and pivotal Phase III. Industry also pays for the government-mandated pre-clinical toxicology work and much else. People should not be fooled by the idea that the NIH is responsible for drug R&D - they only fund early-stage R.
11/24/2009 5:31 PM EST
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