The Food and Drug Administration has a culture of secrecy and a seeming lack of concern about reports of generic drug failures from patients, physicians and pharmacists. The response from the FDA, if there is one, goes something like this: “Generic drugs are identical to brand name medications. Trust us, we know what we are doing and what is best for the American public.”
For nearly 25 years we at The People’s Pharmacy were among the most enthusiastic supporters of generic drugs in the country. We trusted the FDA to do the right thing when it came to approving and monitoring generic drugs. When we received a complaint from a doctor or a patient, we were quick to reassure them that the FDA knew what it was doing. Reports of generic drug problems often seemed to be a ploy by the big brand name drug companies to discredit cheaper generics. Patients who insisted their drug didn’t work might have other factors contributing to the problem.
Our belief that all was fine and dandy with generic drugs began to change around the time the Boston Globe reporters began digging deeper into the sex abuse reports. We had finally received too many reports from patients about generic drug therapeutic failures to ignore the question. So in 2002 we began a series of interviews with FDA staffers in the Office of Generic Drugs, the Division of Manufacturing and Product Quality in the Office of Compliance at the Center for Drug Evaluation and Research and the Division of Prescription Drug Compliance and Surveillance. What we learned shocked us.
We discovered that while the law calls for inspections of all pharmaceutical manufacturing plants every two years, the FDA did not have enough resources to accomplish that goal in the U.S. We later learned that when it came to places where most of the active ingredients in our pills are now made (China and India), many plants were never inspected. We also learned that the FDA does very little checking of pills on pharmacy shelves to verify quality. We were told that the agency analyzed about 300 “finished dosage forms” annually for about 50 or 60 different drugs. That represented about 0.00001 percent of the 3 billion-plus prescriptions filled in community pharmacies in 2002.
The FDA’s attitude seemed to be that any complaints by patients about generic drug quality were not reliable. Some officials appeared to believe that the problems patients reported might be psychosomatic. We came away with the distinct impression that the FDA preferred to hear, see and speak no evil about generic drugs. When we forwarded hundreds of reports from patients who had difficulties with generic drugs, the agency was not forthcoming. The one time the FDA actually released bioequivalence data (the antidepressant Wellbutrin XL 300 vs the generic Budeprion XL 300), the results actually confirmed our suspicions that the two formulations were not “identical.” In fact, we learned that the FDA approved Budeprion XL 300 without requiring any bioequivalence data at all on that dose. The only data available was on a formulation that was half as strong (Budeprion XL 150).
Requests to the FDA for information about complaints it received regarding generic drug problems were also met with silence. Although the FDA has bragged that it is committed to transparency, that policy does not seem to apply to questions about generic drugs.
An investigative report just released by journalists from Reuters describes an audit of a fake Chinese drug company:
“just one of the ‘showroom’ factories intended to disguise China’s thriving industry in substandard and counterfeit drugs. Four years ago, Beijing promised to clean up its act following the deaths of at least 149 Americans who received contaminated Chinese supplies of the blood-thinner heparin. But an examination by Reuters has found that unregulated Chinese chemical companies making active pharmaceutical ingredients (API) are still selling their products on the open market with few or no checks.”
It is time for the FDA to come clean on all the reports it has received about generic drug failures. The agency needs to admit that it does not–indeed, cannot–monitor the quality of OTC or prescription pills on pharmacy shelves. The FDA needs to tell physicians and pharmacists that many long-acting generic drug products rely on different release formulations from the brand name medication. That’s why using the word “identical” to describe generic drugs relative to their brand-name counterparts is misleading. Not only may the release formulation differ from the brand name product being “copied,” but the binders, fillers and coloring agents may also be different. The FDA needs to encourage patients, physicians and pharmacists to report generic drug failures directly to a separate office that is dedicated to tracking trends and investigating problems. The FDA should then share its findings in an open manner with health professionals, the media and the American public.
Until that day arrives you may wish to read some of the reports of generic drug failures we have collected on our website over the last several years. If you would like to learn more about our generic drug investigation, you can find chapters in our books, Best Choices From The People’s Pharmacy and Top Screwups Doctors Make and How to Avoid Them. Should you wish to report a generic drug problem to the FDA’s MedWatch program, here is a link. Don’t expect to hear back from the FDA. They rarely respond to patients, physicians or pharmacists about such reports. And don’t expect them to do anything until the American public, the media and policy makers in Washington, D.C. hold their feet to the fire.
Anyone who would like to report an experience with a generic drug may comment below. We will pass your message on to the FDA. If you can supply a generic manufacturer’s name, that would be quite helpful. If you have a lot number, that would be even better. The FDA needs that information before the agency would even consider investigating a problem with a generic medicine.
