Bottle of Lies: The Inside Story of the Generic Drug Boom

An AIP is a type of punishment imposed by the FDA, typically in the form of increased scrutiny and inspections, on generic pharmaceutical manufacturers who have been found to engage in fraudulent practices or data manipulation. The AIP allows the FDA to freeze the applications of a particular drug company. To resume the review process, the company must take corrective actions and demonstrate compliance with FDA regulations.

ALCOA, an acronym that stands for Attributable, Legible, Contemporaneous, Original, and Accurate, is a set of principles for data integrity in the pharmaceutical industry. This phrase came to prominence in the 1980s, when the FDA started emphasizing the importance of maintaining accurate and reliable records in drug manufacturing.

When evaluating generic drugs, the FDA examines the bioequivalence curve, which represents the relationship between drug concentrations in the bloodstream and time. The bioequivalence curve is used to compare the pharmacokinetic profiles of the generic drug and the reference (brand-name) drug, ensuring that the generic drug reaches similar levels of drug concentration in the body as the brand-name drug, within acceptable limits.

In the context of drug manufacturing, a chromatogram is a graphical representation of the separation of different components in a mixture. It is created through a technique called chromatography, which is commonly used in quality control and analysis of pharmaceutical products. Peter Baker, an FDA inspector and former chemist, sometimes inspected chromatograms to identify potential issues or discrepancies in the manufacturing process.

Current good manufacturing practices, or cGMP, refer to regulations and guidelines set by the FDA to ensure the quality, safety, and consistency of pharmaceutical products. Over time, the FDA shifted its focus to the process and conditions under which drugs are manufactured, requiring adherence to cGMP standards, rather than just focusing on the final product.

The False Claims Act, also known as the “qui tam” or whistleblower law, is a federal law that allows individuals to bring lawsuits on behalf of the government against companies or individuals who have defrauded the government. Thakur’s lawyer was able to file a lawsuit under the False Claims Act, revealing the fraudulent practices of Ranbaxy and exposing their violations of FDA regulations.

A generic drug is a pharmaceutical product that is supposed to be equivalent to a brand-name drug in terms of active ingredients, dosage form, strength, route of administration, and intended use. Generic drugs are typically cheaper than brand-name drugs and can be produced once the patent for the brand-name drug expires. They must take the same form and demonstrate the same therapeutic effects as the brand-name drug, as confirmed through bioequivalence studies conducted by the FDA, but the manufacturers of generic drugs must use a different manufacturing process than their brand-name counterparts.

Interim fraud is a term used to describe fraudulent activities or practices that occur during the time period between FDA inspections or audits. Ranbaxy committed interim fraud.

Official Action Indicated, or OAI, is a term used by the FDA to indicate that significant regulatory violations have been found during an inspection or investigation of a pharmaceutical manufacturing facility. It is the strongest evaluation that the FDA can make, indicating that the violations are serious and require corrective action to ensure compliance with regulations.

No Action Indicated, or NAI, is a term used by the FDA to indicate that no significant regulatory violations have been found during an inspection or investigation of a pharmaceutical manufacturing facility. It signifies that the facility is in compliance with FDA regulations and no further action is required at that time. In the context of the book, inspector Mike Gavini was known for giving out NAI evaluations even to companies with significant regulatory violations, raising questions about his credibility as an FDA inspector.

In the context of drug manufacturing, stations refer to intervals at which a drug must be tested. Drugs must be tested for stability at different stations, for instance, every three months.