Generic Drugs Require Labeling Revisions

Generic Drugs | maher law firm | frank eidson

The consumer rights group “Public Citizen”, claims there are over 433 generic drugs for which no brand-name drug remains on the market today. On Monday, the U.S. Supreme Court blocked design defect lawsuits against generic drug makers causing tremendous pressure on the FDA (Food and Drug Administration). Earlier this year, the FDA considered allowing generic [...]

Generic Drug Companies Fund FDA User-Fee Program

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A tentative deal between the generic drug industry and the federal government will require generic drugmakers to pay annual fees in order to increase FDA inspection of foreign-based manufacturing plants. The proposed deal, which totals approximately $299 million, is similar to the ones that currently exist for companies who produce brand-name drugs and medical devices. [...]

Patients Taking Generic Drugs Need More Protection

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In a recent ruling issued by the U.S. Supreme Court, generic drug companies are not responsible for insufficient warnings to patients regarding the potential dangerous side effects associated with the use of their products, provided that their packaging labels are identical to those of the brand name medications they duplicate. The ruling provides no real [...]

Generic Drug Companies Protected by Supreme Court Ruling

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According to last Thursday’s ruling from the U.S. Supreme Court, the makers of generic drugs cannot be sued for failing to sufficiently warn patients of their drugs’ dangerous side effects. Brand-name companies can still be held liable for patient injuries caused by insufficient warnings, but the same legal duty is not applicable to companies manufacturing [...]