For decades, pharmaceutical companies have deployed an array of tactics aimed at preventing low-cost copies of their drugs from entering the marketplace.The problem is that Pharma can use its monopoly rents to continue to game the political system to f%$# the rest of us.
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.
Brand-name companies say they are protecting themselves — and patients — in case the drugs are somehow used improperly. They say no law requires one company to do business with another.
Advocates for generic drugs say the practice could limit access to the low-cost drugs, which they say have saved more than a trillion dollars over the last decade. They say the companies that have most aggressively pursued the tactic tend to be those with drugs that are nearing the end of their patent life.
It needs to stop.
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