Drug Makers Use Safety Rule to Block Generics

For decades, pharmaceutical companies have deployed an array of tactics aimed at preventing low-cost copies of their drugs from entering the marketplace.

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Contention in Making Generic Drugs

But federal regulators contend the latest strategy — which relies on a creative interpretation of drug safety laws — is illegal.

The new approach is almost elegant in its simplicity: brand-name drug makers are refusing to sell their products to generic companies, which need to analyze them so they can create the copycat versions.