Lately we have written several articles discussing generics here in the US. Such as how some generics are a cheaper option but still many choose not to use them, as well as how if you use a generic, you give up your right to sue the company.
Now, more we bring you more news about generics. Congressional Democrats have just introduced joint legislation to change generic drug labeling rules when new risks or side effects are discovered, which is currently done for brand-name medications.
Democrats in the Senate and House have introduced companion bills that would permit generic drug companies to update warning information about the drugs they manufacture, a change that could allow patients to sue the companies for failing to warn about the risks of taking their drugs.
The legislation, released by both chambers of Congress, is entitled the “Patient Safety and Generic Labeling Improvement Act.” The Act covers issues that were part of last year’s U.S. Supreme Court’s decision in Pliva v. Mensing. Pliva v. Mensing, barred patients from suing generic drug companies because the court ruled that the companies did not have control over what their labels said and therefore could not be sued for failing to alert patients about the drugs’ risks.
An earlier Supreme Court decision, by contrast, gave permission to patients who took brand-name drugs to sue the drug manufacturers. Since the decision last year, dozens of judges have thrown out cases filed by patients who claim they were harmed by generic drugs even though in many cases they suffered the same injuries as those who took the brand-name versions.
The consumer advocacy group Public Citizen has asked the Food and Drug Administration to take a similar action, but the agency said last month that it needed more time to decide on the issue.
Generic drug companies have opposed such a move because they say it could create a chaotic situation in which several different drug companies could publish conflicting warning information about the same drugs. Under current law, only brand-name drug companies can update the labels — the lengthy list of a drug’s uses, dosages and risks — and generic manufacturers are then required to follow suit.