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Eric Betts

FDA proposes safety regulations for brand name, generic drugs

By Nkoyo Iyamba | Posted - Nov 8th, 2013 @ 8:12pm

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SALT LAKE CITY — <a href=" "_blank">The Federal Drug Administration announced on its website Friday a proposal that would allow generic drug manufacturers to independently update safety information about their medications.

The FDA reports the move would ensure information for all drugs have the same label and would level the playing field for both generic and brand name drug manufacturers.

Under the new rules, the generic drug companies would be allowed to independently update safety information on their drugs and then notify the brand name companies of those changes. The FDA would then review the changes.

"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. "More than 80 percent of prescriptions filled in the U.S. are for generics."

Jason Lang, owner of Lone peak Pharmacy in Draper, said most generic drugs are virtually the same as their corresponding brand names.

"People's hands are tied with whether or not they can even take a brand name medication, because brands are very expensive and insurance companies often dictate whether or not they can even use it," Lang said.

Currently, brand name drug companies have been able to independently strengthen their warning labels in response to adverse effects reported by consumers. Generic manufacturers must notify the FDA of new safety information and wait for the FDA and the brand manufacturer to determine the updated labeling. The FDA reports this could result in a delay in getting new information to health care professionals and patients.

Lang said the proposed changes are good because it would encourage more research for drugs.

"A drug is only studied for so long before it comes to the market. And more adverse effects are often discovered once a drug has already been on the market," Lang said.

Drugs react differently for each person, so reporting side effects to health professional is largely up to patients, Lang said.

"You take a drug for one particular thing but it reacts all over in your body and can cause side effects nobody saw coming," Lang said.

The FDA proposal will go through a 60-day comment period before it makes a final decision. Until the change occurs, Lang recommends patients ask their pharmacists a lot of questions, and he said that doctors should spend more time with their patients to make sure they understand what they're taking.

<a href=""_blank">The Generic Pharmaceutical Association is already weighing in. On its website it reports it is "in the process of careful review with our member companies." The association added it will take the public comment period to evaluate how the changes could impact patient safety and the business practices of its member companies.


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