February 8, 1990 |
The Orphan Drug Act was created to motivate drug companies to develop treatments for an estimated 5,000 rare diseases, some of which afflict only a few hundred people. To compensate for the extremely small markets, the law provides a 7-year monopoly to the first firm that discovers and manufactures a so-called orphan drug.
November 10, 1990 |
President Bush Friday vetoed legislation intended to prevent drug manufacturers from realizing unintended windfall profits from drugs developed under a law designed to stimulate research into therapies for rare disorders. The legislation, approved unanimously by both houses of Congress, would have amended the 1983 Orphan Drug Act, which gives companies exclusive marketing rights and tax incentives to develop drugs for diseases that afflict fewer than 200,000 people.
March 17, 1992 |
There's an effort in Congress to curtail the market monopolies awarded to some drugs under the Orphan Drug Act, a federal law whose beneficiaries so far include Amgen Inc. and its blockbuster drug Epogen. But even if the proposed changes in the law are passed and survive President Bush's threatened veto, don't look for Thousand Oaks-based Amgen to get hurt. That's because Amgen's patents on Epogen give the drug a second coat of armor against competition.
December 18, 1985 |
The federal government has awarded Genentech a seven-year monopoly in the sale of a genetically engineered growth hormone, allowing the South San Francisco firm to rack up what is believed to be another monumental first for itself and the fledgling biotechnology industry. The Food and Drug Administration on Monday gave Genentech's drug, called Protropin, status as an "orphan drug" for the treatment of growth hormone deficiency and Turner's Syndrome, a chromosomal disorder in female children.
March 11, 1992 |
It was a law with a curious name and grand intentions: to provide financial incentives that would motivate drug companies to develop treatments for an estimated 5,000 rare diseases. Without such incentives, the reasoning went, drug companies would be unlikely to do the research and production on their own. Some of the diseases afflicted only a few hundred people nationwide, meaning it would have cost the companies more to produce the drugs than they could hope to earn from sales.
September 9, 1990 |
When Julie, the daughter of a State Department development official, packed for an overseas post with her parents in 1989, part of her luggage was a small ice cooler carrying $20,000 worth of hGH, a drug designed to aid the growth of children who lack certain hormones. Julie, a 14-year-old with the stature of an 8-year-old, is one of perhaps 15,000 children who suffer from a rare disorder, an abnormally low growth rate, and who use the recently developed biosynthetic hGH to treat their disease.