George, the FDA is one of the main reason biotech industry could thrive in the US.
The patent system and the effectiveness requirements by FDA are the reasons biotech could exist.
Look at all the countries with very lax system, Where are the products? Even Europe is a wasteland compare to the US, Japan prowess? forget it, the only thing their system creates is a huge bureaucracy to ensure Japanese firms a chunk of the business, "drug" industry creations? zero. Japanese firms are learning now and they are joining and funding US biotechs, maybe biotechs will come in Japan.
Europe and Latin America are full of bogus products, ineffective and dangerous... the market eliminates them? of course not, the sales forces of the pharma are king.
Will Wall Street fund biotech to the tune of $100 billions in last ten years just to compete with oilsnake? (ok, CORR integrilin is from snakes) NO WAY.
It is the monopoly of a market that Wall street likes in biotech ,
the enforcement of patents, and the difficulties for the 2nd and 3rd product to come to compete that makes the business possible.
Look at Viagra, very easy to manufacture, in India they have the so called "reverse engineering" of drugs, India's law allow to overpass patents (US is fighting and it looks like India is ready to concede)
Will Pfixer command the market value if India could bring their sildenafil for $0.25 a pill (it costs some 8 cents to produce)?
George, the pharma industry love the FDA, the same way the beer and tobacco industry loves the fight against maryhuana ,until the day that Phillip Morris and Budwiser could grab that market then they will stop funding the Drug free America, yes free of any drug they can not market.
Biotech love the fda, is the only way they could keep big pharma out of their backs, otherwise big pharma will steal their products and ideas. Just look at what they do with their marketing power, a biotech that keeps double digits is considered lucky. It is only the big pharma savvy executives (Aviron, Pcyc, Bgen, Icos)working with biotechs that could get good deals out of big pharma (usually with independent funding for most of the drug development).
No way "the market" could regulate the "safe drugs" and the efficacy will bring the good products up? forget it, it will be like the internet cacophony, but the internet is entertaiment, not a life or health. It does not matter how many of the internet products flunk, and the people who pay for bogus internet product.
Look at surgery, is the nearest seen to a free market of procedures, only in the last few years are placebo and blind studies being performed, the result: many garbage procedure good for nothing are out there and the "market" is wasting $millions.
Even the insurance companies are flood with this procedures, but they are not timid anymore, before they did not care, raising premiums was enough. Now they want control studies for what they pay.
Look at the laser holes in the heart to improve oxigenation, the placebo study shows the value of it to be zero. The insurance industry is worry funding the studies now, and the FDA is looking
more into regulating new procedures, under the cover of approving the devices the FDA is really after the procedures. Look at coronary bypass good but Lipitor is better.
Do you want bpi competing with the other 50 failures of the last ten years in the market place? by the time the market find out which is good Xoma will be a rock garden.
I want bpi to compete with other efficacious products, not with Amgen failure, not with lipo failure, not with ABTI failure. |
