FDA moves to make generic drugmakers more accountable
Loophole could put users of generic drugs at riskPlay Video
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Viola Purcell can't even drink a bottle of water without choking. She twitches uncontrollably and has trouble breathing and eating. She says it all started after her doctor prescribed a generic drug for acid reflux.
"I was a happy person and I liked to smile, and I can't smile now," she said, breaking into tears. "There's no smile in there."
She took the prescription drug, metoclopramide, for more than five years, thinking it was safe.
"The doctor told me that 'this is going to make you feel better,'" Purcell said. "But it didn't; it only got worse."
She stopped taking the drug in 2009 after the FDA issued a warning that long-term use of metoclopramide can cause a neurological disorder called tardive dyskinesia, the same condition Purcell now suffers from. So she tried to sue the drugmakers, saying the warning label for her pills was “misleading” and “inadequate”.
But the court threw out her case based on a 2011 Supreme Court ruling. In a 5-4 decision, the justices found generic drugmakers can’t be sued because, under current FDA rules, only name-brand drugmakers are responsible for safety warnings. Generics are required to copy the label from the name brand and have no control over what’s on it, so as a result, they can’t be held liable.
"If you take a brand-name drug, you still have your rights to go to court and hold them accountable," said Purcell's attorney, Larry Jones. "If you take a generic drug, you have no rights. And most people don't realize that."
But a new FDA proposal could change that in the future. On Friday the agency announced a proposed rule that would allow generic drugmakers to update labels with new information, just like brand manufacturers, and potentially open them up to liability. The proposed rule comes more than two years after the watchdog group Public Citizen first petitioned the FDA to close what it called a dangerous safety gap.
"Ultimately, we believe that the generic companies need to be the ones who are primarily responsible for ensuring the safety of their products," said Dr. Michael Carome of Public Citizen. "Right now, no one's doing it adequately."
With more than 80 percent of the prescriptions in the U.S. filled with generic drugs, the FDA said it is important for generic manufacturers to be actively involved in making sure drug labels are up-to-date and accurate.
“This proposal will help ensure that health-care professionals and consumers have access to the latest safety information for medications they use,” said Janet Woodcock, M.D., director of the FDA’S Center for Drug Evaluation and Research, in a statement.
The Generic Pharmaceutical Association told us "patient safety is the foremost concern" and that their products are just as safe as name brands, and that a change in rules would create "unnecessary confusion" and "could drive up costs."
In Purcell’s case, the drugmaker said it provided a detailed warning about the possible risks of tardive dyskinesia going back to 1985, with the same language as the brand-name drug.
But Purcell says that wasn't enough to protect her. Her condition is irreversible and she's still unable to have her day in court even if the FDA rule goes into effect.
"I don't want anybody else to have to go through this," she said. "It's just not right."
The proposed change will now go through a public comment period before it can be finalized. The FDA also announced that it plans to create a new web page where safety-related changes proposed by all manufacturers would be made available.
Of course, when your doctor writes you a prescription, be sure to ask about all the side effects. And when you pick it up from the pharmacy, find out if it's the name brand or a generic.
Statement from Ralph G. Neas, president and CEO, Generic Pharmaceutical Association:
“Patient safety is the foremost concern for manufacturers of generic medicines, which is why both brand and generic companies comply with federal law and strict FDA labeling rules and regulations.
To avoid confusion for patients and their doctors and pharmacists, generics manufacturers are required by law to have the exact same label as the brand or Referenced Listed Drug. Providing identical language that includes uniform safety information assures practitioners that they are receiving consistent labeling they can rely on when prescribing medicines for patients.
This underscores a critical point — once generic medicines pass through extensive FDA review, and they are proven scientifically equal to the brand medicine in terms of safety, efficacy and quality, they are approved by the FDA and required by law to have the identical label.
Multiple, different versions of critical data would lead to unnecessary confusion and uncertainty for prescribers, with potentially harmful consequences for patients. Indeed, the Supreme Court has repeatedly held that generic manufacturers must duplicate the language on brand labels and cannot make changes to a label without FDA approval.
As the FDA considers a rule change for labeling, our member companies support the rational communication of important safety information to health care practitioners. While it is premature to discuss what these changes may be, it is important to note that the impact of such a change could create chaos if multiple sponsors for the same product are expected to distribute revised labeling to reflect new safety information.
Generics currently make up 84% of prescriptions dispensed in the United States and save the health care system $200 billion annually. In a time when the public and private sectors are seeking out health savings, regulatory changes that could drive up costs should be approached very carefully.
The generic pharmaceutical industry continues to work with the FDA and other stakeholders to make sure that any changes to labeling rules and regulations align with federal laws, protect patient safety, and do not hinder patient access to more affordable generic medicines.”
Statement from Teva Pharmceuticals, generic manufacturer of metroclopramide:
The safety of our products is of the utmost importance to Teva and we take our commitment to the millions of patients that take our products seriously. We comply with all federal regulations to report adverse events and give the FDA the information they need when any injury is reported. Unfortunately, all medications carry risks. Manufacturers of prescription drugs provide warnings about those risks in the FDA-approved labeling. Since 1985, the FDA-approved labeling for the brand drug Reglan® has included a detailed warning about the possible risk of tardive dyskinesia. That warning makes clear that the risk of developing tardive dyskinesia from metoclopramide may increase with longer duration of treatment. In compliance with federal law, the FDA-approved labeling for Teva’s generic metoclopramide included that same detailed warning.