WASHINGTON (Sputnik) — The US Food and Drug Administration's (FDA) proposal to allow pharmaceutical companies to provide consumers with drug information that conflicts official FDA drug reviews endangers patients and undermines the agency’s authority, experts told Sputnik.
“This [proposal] completely undermines the FDA regulatory authority on this issue,” Public Citizen Health Research Group founder Sidney Wolfe said on Friday.
“It also poses an increased risk to patients, because their doctors can now be informed with FDA’s blessing by drug companies that the drug is not as dangerous as the label makes it appear to be,” Wolfe added.
The FDA proposal, issued in June 2014, allows pharmaceutical companies to distribute peer-reviewed drug studies among their clients. Those studies might present evidence of lowered risks of medicines than were originally assessed by the FDA.
The hollowing out of the FDA’s regulatory authority would be a tragedy, Director of the Johns Hopkins Center for a Livable Future Robert Lawrence said.
The experts noted that the FDA issued the proposal under pressure by pharmaceutical companies because it is afraid of “offending” the industry.
“There have been some lawsuits by industry against government for having penalized them for various types of off label promotion,” Wolfe explained.
Two-thirds of the FDA’s budget for reviewing drugs, which amounted $750 million last year, comes directly from the drug industry, he added.
Lawrence argued the United States needs to recognize that the only way to have really objective evaluation of science is to fund it with public money.
“When we rely on industry… there is an inherent conflict of interest that compromises the trust of the public,” he said.
On Wednesday, the US consumer rights advocacy organization the Public Citizen sent a letter to the US Department of Health and Human Services (HHS) Secretary Sylvia Burwell asking her to recall the FDA’s proposal.
The FDA is a US federal agency responsible for protecting and promoting public health.
