Drug Makers Use Safety Rule to Block Generics

By KATIE THOMAS, NYT

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

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

The Federal Trade Commission recently weighed in on a legal case over the tactic involving the drug maker Actelion, and earlier this month a federal suit was filed in another case in Florida.

“We definitely see this as a significant threat to competition,” said Markus Meier, who oversees the commission’s health care competition team.

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. Traditionally, the generic drug makers purchased samples from wholesalers. But because of safety concerns, an increasing number of drugs are sold with restrictions on who can buy them, forcing the generic manufacturers to ask the brand-name companies for samples. When they do, the brand-name firms say no.

(More here.)