Health Care

Not all generic drugs are created equal: Why FDA, NIH and Congress need to protect Americans

Blockbuster brand-name drugs may make the headlines, but generics rule our nation’s medicine cabinets. Over 80 percent of America’s drug supply is now generic. And the rapid rise of these treatments is partially attributable to the laws governing dispensation: pharmacies are legally allowed to swap in low cost generics for their relatively pricier brand name equivalents.

Such substitution rests on a simple assumption: brand names and their approved generic alternatives are chemically equivalent, operate the same way in the body, possess the same therapeutic powers and run the same health risks.

That assumption has largely gone unquestioned by policymakers. But an emerging body of evidence is showing otherwise. Indeed, reports of substituted generics degrading patient health are growing. And the legal status quo may be putting people at great danger.

Over the last couple years, there have been several major instances of popular generics failing to prove bioequivalent to the brand name they’re based on.

The key bit of legislation governing generic substitution is the Hatch-Waxman Act, a federal law from the early 80s that empowered pharmacists to swap brand names for generics and allow any approved generic to be switched with any other without having to notify patients or their prescribing physician.

The Hatch-Waxman Act conceives of brands and generics as “bioequivalent,” meaning they work the same and serve the exact same medical function. But that term is often just a useful fiction. In real life, there can be significant chemical differences between a brand and its generic copies and most importantly between generic copies.

Often times, those differences are attributable to shoddy generic production. India has emerged as a major manufacturer of generics. But the country suffers from lax quality controls, with spotty regulatory enforcement and many companies that simply refuse to play by the rules. As a result, several major Indian drug firms have been forced to issue huge generic drug recalls out of quality concerns.

Over the last couple years, there have been several major instances of popular generics failing to prove bioequivalent to the brand name they’re based on.

Take levothryoxine, for instance, a popular generic thyroid medication. In 2007, one major investigation found 160 people who reported a sickness after being swapped onto the drug. And a 2012 study found that it was not equivalent for children suffering from a particular kind of thyroid disorder.

There’s a similar story with Budeprion, the generic for a popular anti-depressant. A 2007 investigation found that hundreds of patients that had been switched onto Budeprion from its brand name had suffered a relapse of depression, headaches, anxiety, or some other serious mental health problem. Subsequent research identified the culprit: Budeprion released its active ingredient much faster than its brand name, leaving patients effectively unmedicated several hours after taking it.

Furthermore, research has shown that the amount of active ingredient received by the patient, between brand name and generic immunosuppressants -- a drug class frequently used by organ transplant recipients -- can vary by up to 25 percent. One oral generic immunosuppressant called SandCya actually had to be recalled because its therapeutic effects were disrupted if a patient drank apple juice. That interaction was exceptionally problematic because apple juice is a popular medium for administering the drug to children.

For many patients, a generic substitution is harmless. They’ll save a few bucks and receive the exact same quality of care. But for some, that switch -- particularly if they or their doctor hasn’t been notified -- is dangerous, or even deadly.

Our national drug authorities should step in and take concerted steps aimed at better protecting patients.

For starters, the Food and Drug Administration needs to collect and publish a full comparison of all popular brand name drugs and their most common generic substitutes. Any instances of adverse health effects resulting from substitution should be tracked. And this data must be presented in a clear and concise format easily comprehensible to patients and physicians.

Next, the National Institutes of Health should finance research into the long-term health impacts of generic substitution. Right now, there are zero federal investigations into this practice. Research needs to be empowered to determine if there are in fact widespread adverse health effects for specific drug classes.

Finally, regulators need to require that the labeling on all generic drugs clearly identifies its manufacturer. Patients need to know if their medicines originate from a country or an individual producer with a poor production record.

There is a positive commercial side to this demand. Generic manufacturers making good quality bioequivalent products, of which there are many, right now cannot differentiate themselves from their shoddy competitors. Good companies should be able to advertise their superior reliability of quality manufacturing. It’s a safe bet that patients would be happy to pay a few cents more per pill for generics with better track records. Right now patients and their physicians have to fight with insurance companies and pharmacists to get the specific medicine they want, and the vast majority don’t even think to do it. This must change.

New generation complex biologic drugs, where perfect generic copies will not exist, are hitting the market, and will cause FDA even more headaches in establishing equivalence of performance. It’s time the rules were updated and companies allowed to compete properly – patients are suffering from the status quo.  

Roger Bate and Dinesh Thakur are co-authors of “Drug Inequality,” a new paper published this week.

Dinesh Thakur is the CEO of Medassure Global Compliance Corporation. 

Roger Bate is a scholar at the American Enterprise Institute and the Director of the Safe Medicines Coalition.

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