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Clark Love & Hutson

The Nationally Recognized Plaintiffs Litigation
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The Nationally Recognized Plaintiffs Litigation Law Firm

Drug manufacturers and the FDA share labeling responsibility

On Behalf of | May 28, 2020 | Dangerous Drug Litigation |

When Texas residents buy medications, they refer to the informational label to understand the benefits and risks of the drug. The Hospitalist explains that drug manufacturers share responsibility with the Food and Drug Administration to provide adequate warning labels. 

Our firm has represented clients harmed by the unsafe side effects of medications. 

Labels may require periodic updates 

A product’s label generally lists ingredients, risks, contraindications and warnings. The FDA dictates labeling requirements at the time it approves a drug and may periodically demand revisions. 

Drug companies must inform the FDA of additional risks that come to light based on research and consumer experience. A manufacturer may also have the obligation to request a label change to reflect new safety concerns. The FDA may reject a requested update if it believes a manufacturer’s data is premature or not fully developed. 

Manufacturers cannot avoid accountability by relying on the FDA 

Drug manufacturers bear ultimate responsibility for informing the public and the FDA about risks. These companies may have liability if they knew or should have known about the drug’s dangers and neglected to advise the FDA. 

The U.S. Supreme Court has ruled that FDA approval is not enough to insulate drug manufacturers from legal responsibility for inadequate warning labels. Companies may have some protection from liability if they provide the FDA with complete updated risk data and the FDA declines to approve a label change. However, manufacturers must not create broad and unsupported warnings that invite FDA rejection. 

Pharmaceutical companies may allow marketing considerations to influence product and labeling decisions. Our website has information about how consumers can evaluate a drug company’s decision-making process.