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FDA Warns Gilead Over HIV Treatment, Other Meds Produced in Substandard Plant

By October 14, 2010July 18th, 2019Dangerous Drugs

As a defective medication lawyer, I wish that drug manufacturers would learn from one another’s mistakes — but as a recent report suggests, this does not seem to happen. Now that Johnson & Johnson has been thoroughly shamed for its lax adherence to safety protocols, Gilead Sciences Inc. has been warned by the FDA about problems with its contamination prevention and quality control procedures at its San Dimas, Calif., plant. A number of other drug companies have been in the news this year for lapses at their manufacturing plants, suggesting that consumers who use prescription and over-the-counter medications have reasons to be worried about their safety.
The FDA sent the Sept. 21 warning letter because Gilead had failed to respond adequately to problems found by the FDA’s inspections in January and February. One of the problems the FDA identified was that Gilead wasn’t taking defects in its drugs seriously enough. For example, the company changed its manufacturing process for Viread, an antiviral treatment for patients with HIV that made $668 million in sales last year. After it made the change, the company began discovering “excessive amounts of defective tablets,” the FDA said, but the company concluded that the changes to its manufacturing process were blameless.
This was not the only problem the FDA turned up. Reportedly, Gilead also didn’t investigate the extent of the defects in the drug. A contract manufacturer had produced the drug, and Gilead packaged it. Multiple lots of the drug failed visual inspection, but Gilead just removed the defective pills and went ahead with packaging the rest, without trying to find out what had gone wrong and how to fix it. In addition, Gilead failed to ensure that sterile products remained sterile. Certain lots of the fungal infection treatment AmBisome, which made $300 million in sales in 2009, were processed in a room that wasn’t approved as an aseptic setting. That medication was released for sale in the U.S. The FDA told Gilead that its “senior management” needed to set up systems that would ensure the identification and correction of problems and “assure the identity, strength, quality, and purity of their drug products.”
Gilead is known for its HIV medications. Thus, the problems the FDA identified with Gilead’s manufacturing processes suggest that patients whose lives are already threatened by HIV infections may face the additional threat of contaminated medications. As a dangerous drug attorney, I worry that situations like this point to a drug manufacturer’s being more interested in profits than in people’s health.
Victims who have been hurt by dangerous or defective medications can require the defective product’s manufacturer to pay for the harm that they caused. The law requires drug manufacturers to warn consumers about risks that they know to be linked to their products. If they fail to do so, consumers who are harmed by the defective drugs can sue for financial compensation. A victim who incurs medical costs, misses work or is unable to work, or whose quality of life suffers because of harm caused by a drug can make the manufacturer pay these costs. According to the law, consumers who trusted that a medication was safe should not have to bear the consequences alone, if they find that the drug was unsafe. This is true regardless of whether the manufacturer knew about problems with the medication.

The dangerous medication attorneys at Carey, Danis & Lowe help people who have been hurt by over-the-counter and prescription drugs. If you or someone you love haa been seriously harmed by a medication, we can help you get compensation for your medical expenses, lost wages, permanent injuries, pain and suffering and more. If you have been hurt by a defective drug, please call Carey, Danis & Lowe for a consultation, toll-free, at 1-877-678-3400 or contact us through our website.