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Faster Drug Approvals Linked to Safety Issues

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FDA, Industry Counter Findings continued...

"Additionally, PDUFA funding has helped the FDA modernize and transform the post-market drug safety surveillance system. It has helped ensure the safety of drugs after they are approved for as long as they remain on the market and [has] increased FDA's drug safety surveillance capacity. FDA has been able to adopt new scientific approaches and improve the utility of existing tools for the detection and prevention of adverse events, including obtaining access to the best available databases to better analyze drug safety signals."

Similarly, Robert Zirkelbach, senior vice president of communications for Pharmaceutical Research and Manufacturers of America, emphasizes the benefits of the updated system.

"Prior to 1992, the drug review process was unpredictable, lagging behind other countries and stalling patient access to critical new medicines," he says in a statement. "Providing the FDA with stable, consistent funding, PDUFA revolutionized the [drug review] process and strengthened the agency's high safety and efficacy standards."

He continued: "Since its enactment in 1992, PDUFA has sped up patient access to over 1,500 new medicines, including treatments combating some of our nation's most deadly diseases. By injecting greater consistency, transparency, and predictability into the drug review process, PDUFA has played a crucial role in improving public health."

To improve people's safety, the researchers suggest several actions that could be taken.

For instance, doctors and patients could consider whether a new drug is a “breakthrough,” and consider alternatives if it's not. A symbol on labels or marketing materials could identify newly approved drugs. And the FDA could focus more on doing follow-up studies on available drugs, looking for any side effects that didn’t show up while the drugs were getting reviewed for approval.

Drugs taken off the market before PDUFA "had an average review time for submission and approval of 3 years. The ones that were taken off after had an average review time of 1 year," says study coauthor Sidney M. Wolfe, MD, founder and senior adviser at the Health Research Group, Public Citizen, Washington, D.C. "That was certainly one of the purposes of PDUFA, but the failure to really treat these two groups of drugs [breakthrough and non-breakthrough] differently is what the problem is." 

"I'd like to say that the primary mission of the FDA is to ensure patients' safety,” Frank says. “Our study raises concerns about how well the FDA is doing this. The FDA needs to make sure drugs are safe before they're approved, not rush to judgment in order to meet artificial deadlines. In the meantime, doctors and patients should avoid new drugs, especially when older, safer drugs are available."

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