FDA Looking To Close Loophole That Slowed Safety Warnings On Generics

pillspillspilllsImagine for a moment the tale of two friends, Jim and Joe. Jim takes Gleemonex, which makes it feel like it’s 72 degrees in your head all the time. Joe takes a generic form of the drug, which we’ll call walmonex. If the folks who make Gleemonex realize there’s a problem with the drug, they can immediately slap a warning on the product before getting FDA approval, but if the makers of the walmonex discover that same problem, they currently have to wait for the FDA and the brand-name drug makers to review the issue. This loophole is, quite obviously, a bad thing for consumers. So it’s good news that the FDA is now looking to close it.

The proposed rule would allow “generic drug makers to use the same process as brand drug manufacturers to update safety information in the product labeling.”

Thus, when the some scientist in the walmonex labs realizes that users are inexplicably lapsing into blissful but catatonic states, the manufacturer of the generic can then move ahead labeling their product accordingly, and without having to wait for FDA approval. It would, of course, be required to pass this info on to the makers of brand-name Gleemonex.

Thus, the FDA would be allowed to proceed with investigating the issue to determine whether the warning needs to be placed on the brand-name drug, all while not holding up the labeling on the generic. And if the Gleemonex folks want to follow the lead of the generics, they would be able to place that warning before being told to do so.

Given that generics make up the overwhelming majority (80%) of prescriptions filled in the U.S., it’s incredibly important that everyone, from the doctors to pharmacists to patient and caregivers, have the most accurate information available.

“This proposal will help ensure that health care professionals and consumers have access to the latest safety information for the medications they use,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

In addition to giving makers of generics the ability to craft warning labels in advance of FDA review, the agency plans to create a publicly available web page where safety-related changes proposed by all drug manufacturers would be posted.

Public Citizen, which petitioned the FDA to close this loophole, says it thrilled by today’s announcement.

“Many potential hazards are not discovered until years after drugs have been on the market,” explain Allison Zieve, Director, Public Citizen Litigation Group and Dr. Sidney Wolfe, Founder and Senior Adviser, Public Citizen’s Health Research Group, in a statement. “Yet, currently, generic drug manufacturers can do little to warn doctors and patients about newly discovered information, putting patients at risk. The new rule should remedy this public health problem.”

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