The FDA Lacks Oversight And Regulations On Overseas Drug Manufacturers

China and India manufacture 80 percent of the ingredients that go into the drugs Americans consume

Thursday, July 15, 2021 - Online prescription drug testing pharmacy Valisure has sought to fill the gap between a drug's FDA approval and the chemical safety of the actual manufactured product immediately before it is consumed by the public. The interpretation of Zantac's inherent instability was due to finding elevated levels of NDMA in every Zantac tablet Valisure tested. The company's CEO has been adamant that ranitidine is an inherently unstable molecule and is defectively designed to degrade and become carcinogenic when stored or transported improperly. The door is open to re-evaluating the causes of NDMA contamination of Zantac now that elevated levels of NDMA were discovered in Pfizer's smoking-cessation drug Chantix. Zantac lawyers offering a no obligation free consultation are experienced attorneys with vast experience litigating against big pharmaceutical companies.

The FDA has acknowledged that it does no tests of its own for quality control of drugs coming from overseas where they may have passed through hundreds of hands before making their way to store or pharmacy shelves. According to Light's testimony, the FDA has conceded that "inspection findings have not been a reliable predictor of the state of quality." Light also quoted the 2010 FDA white paper as stating, "product recall and defect reporting data demonstrate unacceptably high occurrences of problems attributed to inherent defects in product and process design; these data further indicate failures in the implementation of manufacturing process scale-up as well as routine production."

Heating ranitidine to higher than room temperatures causes it to break down and become N-Nitrosodimethylamine (NDMA), a deadly carcinogen. Before the Valisure assertion, it was theorized that other factors could have been the cause of the increase in NDMA as certain blood pressure and diabetes medications also were shown to contain levels of NDMA above the 96 nanograms per tablet safety threshold set by the Food and Drug Administration (FDA). In June of 2020, Valisure's CEO David Light's testimony before the U.S. Senate Finance Committee expressed concern about the overseas drug manufacturing process possibly being a cause of the non-related drugs similar contamination. Light told Senators, "With roughly 80 percent of ingredients in U.S. medications manufactured in India and China, medication quality is constantly called into question. There are roughly three, drug recalls in the U.S. every day, and about 100 of those recalls every year are “Class I,” which are considered potentially life-threatening. These recalls can be attributed, at least in part, to the fact that the chemical quality of medications is primarily checked by manufacturers, which self-report the results. Most manufacturers are located overseas, where oversight by the FDA is difficult and fraud is commonplace."

The Pfizer Chantix NDMA spike will surely complicate the upcoming Zantac Cancer Science day on September 30, 2021. Judge Robin Rosenberg will hear testimony from scientists about the safety of ranitidine or lack thereof, and also attempt to get to the bottom of what causes NDMA to accelerate. Thousands of individuals have stated their intention with attorneys around the nation to file lawsuits holing Sanofi liable for failing to warn them about Zantac's carcinogenic potential.

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Lawyers for Zantac Heartburn Medicine Lawsuits

OnderLaw, LLC is a St. Louis personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The Onder Law Firm has represented clients throughout the United States in pharmaceutical and medical device litigation such as Pradaxa, Lexapro and Yasmin/Yaz, where the firm's attorneys held significant leadership roles in the litigation, as well as Actos, DePuy, Risperdal and others. The Onder Law Firm has won more than $300 million in four talcum powder ovarian cancer lawsuits in St. Louis. Law firms throughout the nation often seek its experience and expertise on complex litigation.