Almost every conversation we have at the kitchen table or in our public discourse in the context of our prescription medicines is regarding price, and for good reason. Profiteering among some within in the pharmaceutical industry compels many of us into situations where we are forced to make a decision between putting food on the table versus cutting our prescription pills in half. This is clearly unacceptable.
A significant outcome of this dilemma is addressed by generic drugs that are on the other end of the pricing spectrum. Many of our medications taken for chronic, long-term conditions are filled with generic drugs for less than $20 for a month’s supply. The U.S. Food and Drug Administration (FDA) has done such a good job of convincing us that generic drugs are the same as their branded counterparts because they have the agency’s stamp of approval. But the reality is far from what the FDA has led us to believe.
The supply chain that fills our prescriptions at the pharmacy has become extremely complex. Raw materials often come from China, and they are made into pills, syrup or an injection more often than not in India. Eighty-percent of the U.S. drug supply by volume today has significant components manufactured overseas.
The most aggressive pushback we see from the generic drug industry is to ask us to show why patients do not fall sick when taking substandard, poor quality generic drugs. Where are the body bags, they ask? Unfortunately, health-care providers do not report these lack-of-effect cases as often as they should. Patients are most often told that their physiology is not “responding” to the drug, and their prescription is switched to a different formulary or directed to be filled “dispense as written,” which means the pharmacist cannot substitute a generic equivalent for the drug that the doctor prescribed.
If you take thyroid medication, you know how important it is to get the dose right. Same goes for ADHD drugs, birth control pills and pain medications. Narrow therapeutic index drugs cause significant side effects and worse if they do not comply with the tightly tolerated variance in our bodies. Fortunately, some have already learned from experience and are taking corrective actions, like the cardiologists at Cleveland Clinic.
The FDA walks a very fine line between ensuring the quality of our drug supply and not creating shortages in the market. Even in cases where their inspections have found gross violations of the U.S. laws, the FDA has allowed the manufacturer to continue supplying specific drugs to our market because they were the only supplier of that drug.
The agency has also admitted recently that its model of satellite offices overseas setup to monitor factories making medicine for our market is not working all that well for a number of different reasons. Policymakers in Congress must take a closer look at the model and its successes/failures over the last six years and figure out what needs to be done differently going forward.
The U.S. Federal Aviation Administration relies on its counterparts overseas to ensure the safety of airplanes owned by foreign carriers that land at our airports. The FDA also needs a competent partner to ensure compliance with good manufacturing standards for facilities located in India. This has been missing for a long time now.
Unfortunately, the FDA’s response has been to double down on its messaging. The Office of Pharmaceutical Quality just released a report saying that the site inspection score, which is an indicator of the quality of product a particular manufacturing site produces for India and China is below the global average. But what the agency does not tell us is that this score was computed with data for over 100 manufacturing facilities where the agency downgraded the recommendation from its own inspectors who went overseas to inspect. A true accounting based on unaltered recommendations from those who spent time inspecting these facilities will most naturally be significantly lower.
Good quality generic drugs are an indispensable part of our public health. They help keep our health care affordable and are key enablers of many of our public programs like Medicare. It is time now for us as consumers and patients to demand better transparency in how this complex, largely overseas supply chain, is regulated for quality by the FDA. We need to be more proactive in learning about where and how our generic drugs are made before we subject our health to products of questionable quality.
Right now, we know more about where our shirts are made, phones are manufactured, and which facility makes our pet foods, because it is disclosed on the label. Our medicine should be no different. Congress needs to enact a law to mandate that the drug company that sells us the generic drug tell us in which facility and in which country that medicine is made.
Dinesh Thakur is the founder of Medassure Global Compliance Corporation, which offers consulting services to the industry and non-profits in the areas of drug quality and supply chain management for medicines. He is a public health activist and policy expert focused on improving the quality of affordable medicines. He has held senior positions within the pharmaceutical drug industry and generic drug manufacturers.