Some generic drugs may not be same as brand names
ABC7 I-Team Investigation
CHICAGO (WLS) -- The ABC7 I-Team reveals new federal efforts to ensure the generic drugs we take each day are safe and effective. But for some patients whose lives are on the line, it's still not enough.
More than 80 percent of prescriptions now filled in the U.S. are Brand X generics. Most people have no issues, but many also have no choice because insurance companies cover only the less expensive copies.
The I-Team has troubling reports of some generics not working as well, and what's being done to guarantee your meds are as good as you're told.
Check the bottle: chances are the medication you are about to take is not the name brand. And most medical experts say that's fine - generics keep many Americans healthy while saving billions of dollars.
"Patients can feel pretty safe about using generics," said Bill Pong, pharmacist, Loyola University Medical Center.
But there has been growing concern that some of these drugs - while often thought to be exactly the same as the brand name - are not. That has transplant patient Mary Prucha terrified.
"It is life and death for me that I do have the name brand," Prucha said.
Prucha, a suburban mother with cystic fibrosis, is on her second lung transplant. For a decade, these powerful brand-name, anti-rejection medications have kept her body in harmony with the donated lungs. But she says her insurance plan is now refusing to pay for the brand name drugs she trusts. Her doctor worries the generics might absorb differently in her body.
"A consistent amount of drug level in their bloodstream really helps to prevent rejection," said Dr. Erin Lowery, transplant pulmonologist at Loyola University Medical Center.
According to the FDA, approved generic drugs must currently meet rigorous standards with respect to identity, strength, quality, purity and potency.
"It's not like a generic can just come on the market and nobody's looked at how it works or what the ingredients are," said Jan Engle, UIC College of Pharmacy.
But generic drugs are allowed to use different inactive ingredients, known as fillers. There are reports these inactive ingredients in some time-release drugs may affect the way the drug is processed in the body.
"If you go just a little too high, it can be toxic, a little too low, you know, it could not work," said Dr. Tod Cooperman.
Dr. Cooperman runs ConsumerLab.com. He discovered a generic form of an antidepressant was releasing its active ingredient too quickly. The version was subsequently taken off the market.
Cooperman says a similar problem was found in some generics of an extended-release version of an ADHD drug.
"There are certainly products out there that are not equivalent and there are issues out there that are going to be uncovered only as consumers use these products," Dr. Cooperman said.
The I-Team has learned that the FDA is studying how some extended-release products work to see if federal drug regulations need to be changed.
The agency says it's always tracked how drugs perform after approval but now has a bigger, $20 million effort underway to test generics for safety and quality. Under the microscope are ADHD treatments, antidepressants, heart drugs, anti-seizure medications and anti-rejection drugs.
"We do actively monitor the supply chain, not only the active ingredient, but we have to pay attention to those non-active ingredients even though the onus is really on the manufacturer," said Ricki Chase, FDA Director of Investigations Chicago Dist.
That assurance is not enough for Prucha. Paying for the brand drugs out-of-pocket will cost her an extra $1,500 every three months. It's a price tag she says she can't afford, but she worries her life is on the line.
"The risk is rejection and death," Prucha said.
It's a risk with little recourse should something go wrong. Generic drug makers cannot be sued for adverse reactions to their products because only the name-brand drug makers are responsible for design and safety warnings under FDA rules.
Chicago attorney Bob Napleton has a generic lawsuit case here that he hopes will change that.
"We're hoping this opens the courthouse doors to those people who were seriously injured or died from taking unsafe generic drugs," Napleton said.
The FDA is considering a controversial new rule that would allow generic drug makers to update labels with new information - potentially opening them up to liability.
The Generic Pharmaceutical Association strongly opposes such a regulation, telling the I-Team it could cause confusion and put patient safety and savings at risk, and potentially would add billions of dollars in costs.
ADDITIONAL INFORMATION:
The Safety Reporting Portal - Dept. of Health and Human Services
FDA: File complaint about a medication, Regulatory science and generic prescription drugs
Specific to the funding, many grants and contracts on multiple topics have been issued for studies that are underway, for example:
The results of these studies will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories. Information here: http://www.fda.gov/drugs/scienceresearch/ucm407277.htm
Proposed rule on generic drug labeling that the FDA is working on. Information here: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374171.htm
