For decades, we were told by the FDA, physicians, pharmacists and consumer organizations that generic drugs were “identical” to their brand name equivalents. We believed them. In fact, we led the charge ourselves. We absolutely believed that generic drugs were perfect in every way and that patients deserved to save money. We ranted about the price-gouging of the big brand-name drug manufacturers and encouraged everyone to demand generic alternatives whenever possible.
Our belief in the infallibility of generic drugs began to change about 10 years ago. We have repeatedly documented our concerns on the pages of this website. We have shared thousands of sad stories from readers or our syndicated newspaper column and visitors to this website. Gradually, the carefully constructed story about generic drugs being identical has started to unravel.
Now an article in Fortune Magazine by investigative reporter Katherine Eban has tugged on the thread even harder and revealed some embarrassing truths. We think you will find her report worth reading.
Should you wish to read the whole sordid tale in far greater detail, we suggest our chapter titled “Generic Drug Screwups” in our book, Top Screwups Doctors Make and How to Avoid Them.
We take no pleasure in this unravelling. We want ALL generic drugs to be trustworthy so that patients can save money on these crucial medications. We think it is time for the FDA to tighten its standards when it comes to generic drug approval. We believe the FDA must become more transparent and share bioequivalency data about all generic drug approvals. The American public deserves to see the bioequivalency curves and access the dissolution data on every generic drug approved in this country.
In addition, we absolutely must have 100% inspections of all foreign drug manufacturing facilities where ingredients are made for the U.S. market. These inspections should be unannounced, just as they are in the U.S. It is outrageous that FDA inspectors should have to let the companies know days or weeks in advance that they are coming to inspect the plants. And these inspections should be carried out every two years as required by law.
Finally, the FDA should randomly test both prescription and OTC drugs off pharmacy shelves in the U.S. for quality. Do these pills have the exact amount of medicine that they should and do the pills dissolve as required by law? Right now, we don’t have any way of knowing.
It is time for politicians, physicians, pharmacists and the public at large to demand what they have always assumed they were getting, ie, quality generic drugs! Politicians should make sure the FDA has sufficient resources to ensure this.
Please take a moment to read Katherine Eban’s article in Fortune.