The State of the Drugs Industry, Part I: Expect lighter-touch regulations

If you worry that drugs cause enough serious adverse reactions and side-effects even after passing through a supposed draconian approval process, you’ll be even more concerned about a subtle lobbying that could lead to a relaxation of the licensing of new drugs.

Commentators are claiming that the lack of new drugs being approved each year is reaching crisis point. Only 15 new drugs were approved by America’s drugs agency, the Food and Drug Administration, during 2002 compared with an average during the previous five years of 31. This phenomenon is happening around the world. ‘(Drugs) companies are beginning to shift research budgets towards more aggressive marketing of existing products. These are worrying times’, warn the editors of Nature Reviews Drug Discovery, a medical journal.

To encourage pharmaceutical companies to make more money (as if they’ve ever needed encouragement), the editors surmise that drug companies may be looking for the next blockbuster rather than developing a ‘niche’ drug. Take, for instance, the breast cancer drug, tamoxifen. It is one of the best-selling drugs in the world, generating billions of dollars of income every year, and yet, according to the journal, the drug company anticipated initial annual sales of just £100,000. This seems hard to believe, as it would have taken the drug company 500 years to recoup the licensing costs alone, and before any marketing costs.

But if these heroic tales fail to rekindle the entrepreneurial spirit of our drugs industry, the next step could be to relax the licensing requirements. Remember where you read it first. . .

(Source: Nature Reviews Drug Discovery, 2003; 2: 3).

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