Last year, the U.S. Supreme Court ruled that generic drug makers are not required to update or strengthen warning labels, even when they are alerted to new safety issues or side affects, saying that generic drug companies do not have the same level of responsibility as makers of brand name manufacturers.
In the case, Pliva vs. Mensing, the Supreme Court said that Gladys Mensing could not hold the maker of metoclopramide, the generic form of Reglan, responsible after she developed tardive dyskinesia. This neurological movement disorder is an adverse effect of the drug, and, in 2009, the U.S. Good and Drug Administration ordered the manufacturers of Reglan to strengthen and clarify their label with a warning of this disorder.
Debates have since risen over consumer safety and the responsibility of drug manufacturers. A pair of bills has now been introduced by Democrats in both the Senate and the House of Representatives. These bills would “permit manufacturers of generic drugs to provide additional warnings with respect to such drugs in the same manner that the Food and Drug Administration allows brand names to do so.” This would allow generic drug makers to initiate updates to their labels to reflect any health or safety concerns or information.
Senator Patrick Leahy (D-Vt), who co-sponsored the Senate bill, said, “The Supreme Court decision creates a troubling inconsistency in the law regarding governing prescription drugs. If a consumer takes the brand-name version of a drug, she can sue the manufacturer for inadequate warnings. If the pharmacy happens to give her the generic version, she will not be able to seek compensation for her injuries.”
Last year, Supreme Court Justice Sonia Sotomayor said, “As the majority itself admits, a drug consumer’s right to compensation for inadequate now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. The majority offers no reason to think – apart from its new articulation of the impossibility standard – that Congress would have intended such an arbitrary distinction.”
Generic drugs currently account for nearly 8 in 10 prescriptions filled in the U.S. and is expected to grow in the coming years.
More than 40 judges have dismissed cases against generic drug makers since the Supreme Court’s ruling last June. (site drug and device law)