The Hartford Courant on Sunday examined orphan drugs -- those that treat disorders affecting fewer than 200,000 people -- which are "one of the fastest-growing areas in pharmaceuticals" and can be "extraordinarily costly" for consumers. The drugs often are extremely expensive because they are developed for a small pool of patients and "because developing any new medication is a long, risky and costly undertaking," the Courant reports. The pharmaceutical industry estimates that the cost of developing a drug costs $800 million from inception to human clinical trials, and only 30% of experimental drugs ever receive FDA approval. As a result, "when it comes time to affix a price to an orphan drug, companies are eager to recoup their investment quickly," the Courant reports. The increase in orphan drug development activity can be attributed to a 1983 federal law that offers tax breaks and market exclusivity for such products, as well as the "realization by smaller pharmaceutical companies that the drugs represent a lucrative entrepreneurial niche," according to the Courant.

Source: Number Of Orphan Drugs Increases, But Costs High For Consumers


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