FAQs from my readers
Q: How can I find out which company makes my generic drug?
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.
Q: The company that makes my generic drug is based in the United States, but I’m worried it might be outsourcing manufacturing to foreign facilities. Is there any way to find out exactly where my drug was made?
A: Right now, it's almost impossible to find out exactly where your drugs are made. Because manufacturing costs in India and China are so low, many U.S.-based companies now operate manufacturing facilities overseas. No laws require disclosing country-of-origin manufacturing for drugs or ingredients – companies view this information as proprietary. We need new laws to change this.
Q: I recently switched to a new generic medicine, and it doesn't seem to be working. I feel terrible. What should I do?
A: Pay attention to symptoms and side effects: how you felt before the switch, and how you feel after. If you’re being switched between multiple versions of a drug, keep track of which specific manufacturer works best for you, and demand to stay on that one. You can also report your symptoms to the FDA’s MedWatch database. It’s unlikely that the FDA will follow up with you personally, but if enough patients complain about the same drug, the FDA says it will investigate.
Q: I told my doctor/pharmacist about the problems I’ve been experiencing on this new generic, but nobody seems to be taking my complaints seriously.
Some doctors are keenly aware of variations between different generic versions, particularly cardiologists, neurologists, psychiatrists, endocrinologists and other doctors who prescribe drugs that require precise dosing (so-called narrow therapeutic index drugs). But some doctors and pharmacists have not thought much about this and believe that all generic drugs work just like the brand-name version. If your treatment doesn’t work, they may try to switch you to an entirely different therapy, when really what you needed was a different version of the same generic. Educate them, perhaps with a copy of Bottle of Lies in hand.
Q: I think I've been seriously injured/poisoned by a generic drug, and I still have pills left over. Is there somewhere I can go to get the pills tested?
A: There is no easy or cost-effective way to get your own drugs tested. There are some independent testing laboratories, but the testing is prohibitively expensive for most patients. However, one mail-order pharmacy called Valisure actually does test every drug it dispenses. That model could expand, as consumer awareness of these quality issues grows.
Q: My new generic isn’t working for me, and I’d like to switch. What should I do next?
A: If you’d like to change manufacturers (something I do frequently), you can find out which ones make your drug by looking at the FDA’s Orange Book. Once you have a list of manufacturers that make your generic, ask your pharmacist about whether you can get a different version (they may have to order it from their wholesaler).
One thing to look for is an “authorized generic.” That’s a generic version that has been authorized by the brand-name company, and therefore is likely made using the same formulation, time-release mechanism, often with the same additional ingredients (and sometimes even manufactured in the same plant).
Q: I want to do something about this problem. How can I help?
A: Educate your doctors, pharmacists and lawmakers. Call your Congressperson and demand that country of origin for both the active ingredient and the final formulation be disclosed on the dispensing label. Demand that the FDA conduct no-notice inspections of foreign manufacturing plants and ask for a public Congressional hearing on the topic of generic-drug quality.
Q: I’m worried about the quality of the drug supply. Would you recommend that I stop taking generic drugs, refuse vaccinations for my children and/or stop taking prescription medicines?
A: I want to make it clear that I am pro-science, pro-vaccine and pro-generic. Bottle of Lies is not a critique of modern medicine itself. Rather, the book exposes the consequences of a globalized drug supply coupled with a weak international regulatory system. I realize that the book has alarming implications about medicine quality, but it’s clear to me that the best path forward is to strengthen the regulations that govern the U.S. (and world’s drug supply). This, in turn, would bolster the public’s confidence in their generic drugs, vaccines, and other drug products – and ultimately improve public health.