The Generic Problem with Health Care Reform

06/14/2010 05:12 am ET | Updated Nov 17, 2011

Among the first benefits to reach consumers of the sweeping new health care reform bill is a $250 rebate for seniors to purchase prescription drugs. The rebate will help fill the "doughnut hole" in Medicare's prescription drug coverage, a gap that amounted to about $3,600 per person this year, and was projected to grow to about $6,000 by 2020.

But while making prescription medications more affordable for every American is a laudable goal, increasing the availability of these drugs raises serious concerns about the safety of the American medical consumer, especially when it comes to generic drugs.

The Food & Drug Administration's well-known shortcomings in protecting consumers from dangerous prescription drugs have been illustrated in high-profile examples, like the recent scandal surrounding GlaxoSmithKline's drug, Avandia, as well as Merck's drug, Vioxx. These failures often stem from the relative weakness of the FDA as a regulatory body: overextended and underfunded, the FDA must largely rely on drug companies to police themselves.

While the FDA's current system of policing name-brand drugs is badly flawed, when it comes to generic drugs there is virtually no cop on the beat.

Prescription drugs are brought to market through a complicated process, eventually providing the manufacturer of that drug with a patent, allowing it to market its product free from competition for up a number of years in order to recuperate the expenses it incurred developing that medication. During this time, the manufacturer works closely with the FDA in tracking adverse event reports associated with its drug, analyzing the data to determine who is affected, when, and why, and updating potential warnings as new side effects inevitably appear.

Once the patent on a drug has expired, however, competing generic manufacturers are free to market the product, flooding pharmacies with alternatives to name-brand medications. While these generic manufacturers are also required by law to report adverse effects to the FDA, they often fail to adequately track and analyze them, which can all too often leave consumers at risk.

An unfortunate example of this is the drug Reglan, and its generic form, metoclopramide. Approved for short-term use (three months) in 1979 to treat heartburn and other gastrointestinal problems, generic versions of this drug have been available for years.

Prescriptions of Reglan and metoclopramide skyrocketed after a competitor to Reglan was pulled from the market in 2000. And because of the chronic nature of the conditions metoclopramide is meant to treat (gastroparesis and gastroesophageal reflux) many patients were taking it for much longer than the approved three months.

Unfortunately for the consumer, taking metoclopramide for longer than the approved dosage period raises serious risks of developing tardive dyskinesia, a permanent and debilitating movement disorder. The manufacturers of generic metoclopramide failed to adequately monitor the prolonged usage of its product. In fact, according to the FDA, one in five patients used the drug for longer than the approved three months. As a result, the FDA issued a black-box warning for the medication, the strongest of its kind, in February of 2009.

Because Reglan and metoclopramide had been on the market for so long, many doctors - particularly those without a neurological background - were not aware of the serious neurological dangers associated with the drug. Had its generic manufacturers been appropriately tracking its usage, millions of patients could have been spared that danger.

For many Americans, the cost of prescription drugs, particularly name-brand versions, is prohibitively high. As such, the government should do what it can to increase the availability of both patented and generic medications. But it is crucial that those who manufacturer and sell these products be held accountable for their safety. For too long, generic manufacturers have marketed potentially deadly products without regard for the long-term safety of their products. With the increased popularity of generics and the billions in additional profits that their manufacturers stand to make, this free ride must come to an end.

Blizzard, McCarthy & Nabers, LLC recently launched as a resource for consumers injured by Reglan and Metoclopramide.