The U.S. Food and Drug Administration (FDA) does not test new drugs before deciding whether to approve them for market. Instead, drug makers design clinical trials and submit their own results to the FDA for review. For a drug maker to develop a new drug for FDA approval, it has been estimated to cost between $2 billion to $3 billion. When the drug makers have this much money at stake, are the results of clinical trials left up to chance?
Ryan Duplechin, a lawyer in Beasley Allen’s Mass Torts Section, explored this question in his latest piece written for the Bill of Health, one of the nation’s most popular health law blogs produced by the Petrie-Flom Center at Harvard Law School.
In “The Funding Effect: How Drug Manufacturers Design Clinical Trials to Produce Favorable Results,” Duplechin explains the strategies manufacturers have used to design clinical trials to reach the results they want. Many of these strategies were used in the Vioxx clinical trials, as well as other drugs that were later the subject of mass tort litigation.
“The ‘funding effect’ in clinical trials is just one example why drug companies should not be immune from products liability lawsuits brought by consumers,” he explains. “After a drug receives FDA approval, products liability law still requires manufacturers to identify new side effects and communicate those to physicians. This is why products liability and mass torts are important to public health.”
Read “The Funding Effect” at Bill of Health.