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  • Pharmaceutical Drug Litigation in New York

    With the passage of the Prescription Drug User Fee Act (PDUFA) administered by the Food and Drug Administration in 1992, the Food and Drug Administration (FDA) began placing many pharmaceutical drugs on a fast-track for approval. With the average number of new drugs approved by the FDA increasing by one-third each year, drug injury lawsuits in New York have also increased.

    When drugs enter the marketplace faster, there’s less time for drug companies and government officials to fully investigate the side effects of consuming the drugs. While the pharmaceutical manufacturers have garnered increasing profits for their drugs, consumer safety has proportionally decreased. The combination of many new pharmaceuticals and over-the-counter drugs with fast approval has significantly increased pharmaceutical drug litigation in New York. This has led to increased numbers of dangerous drugs such as Vioxx, Bextra, Celebrex, Crestor, and Zocor, being prescribed to millions of Americans.

    More about PDUFA

    The Act allows the FDA to collect fees from drug manufacturers to fund the new drug approval process. It also allows the FDA to collect a substantial application fee from drug manufacturers in New York, and elsewhere, at the time a new drug application was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. All intended to decrease drug injury lawsuits.

    The move toward imposing user fees to pay for the regulatory review of new medicines was the result of dissatisfaction among consumers, industry, and the FDA. All three groups felt that drug approvals were taking far too long but didn’t want to risk higher pharmaceutical drug litigation in New York and across the country.

    Current drug injury lawsuits in New York vary, but have included drug injury lawsuits for heart attack or stroke, hemorrhagic stroke, diabetes, suicide, or kidney or liver damage or failure.

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