The US Food and Drug Administration is carefully treading a line between product quality and availability by allowing imports of two oft-curative generic cancer drugs from an Indian plant to stem serious shortages that followed a disastrous inspection, but only with strict oversight reminiscent of consent decree terms.
US FDA Balances Urgent Need For Platinum Chemotherapies Against Intas Plant’s Quality Failures
As politicians demand help for cancer-ridden constituents, the agency allows Indian plant that flunked inspection to resume exporting batches of cisplatin and carboplatin to the US, but only after passing independent 45-day batch certification reviews.
