Drug Maker Reportedly Fakes Data for FDA Approval of Generic Lipitor
Lipitor, a popular medication prescribed to those who are struggling with low-density lipoprotein (LDL) cholesterol, or “bad cholesterol,” levels has recently been linked to an increased risk of kidney complications, diabetes and muscle injuries, among other adverse health conditions, according to the U.S. Food and Drug Administration (FDA). According to statistics, 88 percent of drugs prescribed in the U.S. are generic drugs and typically require FDA approval following years of testing. However, reports show that Ranbaxy, a leading manufacturer, may have skipped the required steps for approval of its generic products. While generic Lipitor and Lipitor are made by two different companies, attorneys are noting news pertaining to Lipitor or any other relevant drugs.
If you or someone you love are taking Lipitor and suffered complications or you have concerns about the drug, you may be entitled to file a claim and seek compensation for your injuries.
Drug Maker Accused of Faking Test Results to Gain FDA Approval
An executive employed by Ranbaxy was asked in 2004 to investigate allegations of fraud that may have been occurring within the company. The employee quickly uncovered complications with the data needed to gain FDA approval and prove the effectiveness of the products marketed by the company.
The data is imperative because agencies use this information prior to assigning the product with FDA approval, letting consumers and healthcare providers know that the medication is, in fact, safe. However, according to the employee, none of the data that allegedly existed was found, meaning that the company reportedly gained FDA approval to sell products that were based on fraudulent or non-existing data.
In 2005, the employee brought the matter to the attention of the FDA. After the agency conducted an investigation, it found that Ranbaxy had a “persistent…pattern” of submitting “untrue statements.” In fact, on at least 15 new applications pertaining to generic drugs, auditors noted over 1,600 data errors. The FDA then concluded that the products were “potentially unsafe and illegal to sell.”
In 2011, although one branch of the FDA was investigating the company for criminal violations, another branch was considering granting FDA approval for exclusive rights to make a generic Lipitor, one of the most well-known and best-selling pharmaceuticals of all time. Although FDA officials declined an interview, the agency asserted that Ranbaxy was, in fact, approved to manufacture and market generic Lipitor and that the company had met FDA standards.
What is Lipitor?
In patients struggling with their cholesterol levels, Lipitor can help to prevent the production of the enzyme responsible for creating cholesterol in the liver. Statin medications including Lipitor have been proven to be helpful in those needing to lower their “bad cholesterol” levels although several medications have been linked to muscle injuries, kidney complications and diabetes. Lawsuits have been filed against Lipitor alleging that the manufacturer knew of the potential for Lipitor to cause diabetes prior to releasing its product on the market. Plaintiffs are also alleging that Pfizer failed to inform the public and healthcare communities of the necessity of monitoring patients’ blood sugar levels while taking the medication.
Have Questions or Concerns about Generic Lipitor?
If you or someone you love have been injured while taking Lipitor or you have concerns pertaining to the FDA approval of generic Lipitor, contact the American Injury Attorney Group. We will help answer your questions and provide you with a free case evaluation to determine if you have a valid claim. We will connect you with experienced attorneys who will handle your Lipitor claim and work to help you seek the compensation to which you may be entitled.