Katherine Eban – investigative journalist, Vanity Fair contributor and Andrew Carnegie fellow (also see her TEDMED Talk here). “A: Typically, the manufacturer name will be listed on the pill bottle’s dispensing label. However, this isn’t always the case. If you can’t find the name of the manufacturer on the packaging, call your pharmacist and ask which company manufactured the medicine in your prescription. Although state laws vary, pharmacists are required to keep records of prescriptions dispensed to patients, including documentation of the drug manufacturer’s name, generally for a period of two to seven years. If the prescription is paid by a federal program, the records must be maintained for ten years.
Q: How can I be sure that the company that makes my generic drug is “safe”? A: Once you know the name of the manufacturer that makes your medicine, there are several steps you can take to learn more about their reputation.
- Research the company: You can start by just Googling the company and seeing what you find. Are other patients complaining about the same drug by the same manufacturer? One helpful resource is The People’s Pharmacy, the website that accompanies an NPR radio program, where patients write in and share stories.
- Check inspection records: The FDA inspects and ranks drug manufacturing facilities across the globe, giving each facility one of three grades: Official Action Indicated (OAI), Voluntary Action Indicated (VAI) and No Action Indicated (NAI). If a facility receives an “OAI” grade, it means the FDA found significant problems at the plant that require immediate correction. These rankings are available in the FDA’s Inspection Classification Database. If you enter the name of the company in the “Firm Name” field on this online form, and then click “search,” you should find inspection grades from the past ten years.
- Check warning letters: If the FDA finds serious problems at a manufacturing plant, it will issue a detailed warning letter. You can find a list of these here. Though the letters themselves can be technical, one expert advises to look for two types of problems: issues with sterility and with data integrity (the latter reflecting negligence or possible fraud in the mishandling of manufacturing data). When both issues are present, this can be a clear indicator that the plant has serious quality control problems…”