In September, Congress passed a comprehensive Food and Drug Administration bill delivering OSPIRG-backed prescription drug safety reforms.
The bill holds the prescription drug industry more accountable for the safety of their products by requiring them to publicly disclose drug safety studies, even the ones that show their medicines in an unflattering light. It also increases the budget for drug safety reviews at the Food and Drug Administration.
“This bill is the right prescription for improving the safety of our medicines,” said Laura Etherton, OSPIRG advocate. “This is a huge victory for consumers over the powerful prescription drug industry, which tried unsuccessfully to weaken the drug safety language in the bill.”
How It Makes Drugs Safe
The Food and Drug Administration Amendment Act will prohibit drug makers from hiding unflattering studies about a drug’s side effects. It makes drug companies post the results of drug studies online so researchers, doctors and patients have access to complete information.
It also strengthens conflicts-of-interest rules for scientists who serve on FDA drug safety panels by limiting the number of scientists with financial ties to drug makers by 25 percent over five years.
In addition to eliminating conflicts-of-interest, it strengthens the FDA with the authority to issue fines of up to $10 million for drug makers who fail to complete follow-up safety studies. In the past, drug makers failed to complete drug safety studies nearly 70 percent of the time.
The bill includes a prescription drug user fee reauthorization that provides nearly $400 million of the FDA’s $1.5 billion budget.
The Food and Drug Administration Amendment Act passed the House 405 to 7, passed the Senate unanimously, and was signed by the president.
The bill’s near-unanimous final approval belied the intense debate that surrounded its key provisions, most notably, the requirement for drug companies to disclose clinical trial results—a step vehemently opposed by drug industry lobbyists.
To win, we worked closely with other members of U.S. PIRG, our national federation, which spearheaded the Patients and Consumers Coalition, which included groups ranging from the Union of Concerned Scientists to the Breast Cancer Fund.
OSPIRG urged our state’s congressional delegation to stand behind provisions that would require greater transparency in clinical trials of new drugs, greater independence on FDA drug safety panels, and greater accountability for drug companies that fail to perform required safety studies.
