The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner
Skip to main content

In 2010, the FDA approved a reformulated version of the drug OxyContin. Purdue Pharma, the lab that produces the narcotic painkiller, developed a safer form of the drug—one that would be more difficult for people to use illegally (by inhaling or crushing and mixing with water). At that time, he FDA ruled that the new version of OxyContin has the same therapeutic benefits of the earlier drug, an important piece in the approval process.

This week, some 3 years later, the FDA reported it would not allow generic versions of OxyContin, based on the original formulation, to be released. A victory for Purdue Pharma, the makers of OxyContin—a defeat for the consumer.

We applaud any drug manufacturer’s efforts to help reduce risks related to medications. But, in this case, is the motive patient safety or greed?

Generic drugs are often significantly less expensive for the consumer. A generic drug is not available until the original patent on a medication has expired, often years after the drug is approved. Generic medications don’t have to undergo the strenuous testing required of new medications. The companies have no need to market or advertise these generic versions of well-known drugs. Therefore, we’re able to get these medications at a lower cost. In the case of OxyContin, one 40 mg tablet cost $6. That price is expected to increase now, according to the New York Times. And, now there will be no generic version available for several years.

What happened in the case of OxyContin? The FDA classifies this newly reformulated version of the drug as a new drug. The FDA will "…not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin." (FDA Press Release)

Just as the patent for OxyContin was ready to expire, opening the way of less-expensive generic versions, Pharma Pharmacy suddenly announced a new ‘tamper-proof’ product. Yes, the potential for abuse will be lessened, but this new and improved version keeps the monopoly on the drug in place. Coincidence? The FDA does not’t think so, "While companies like Purdue Pharma (and Endo) insist the public’s health is their main concern, others note that producers introduced tamper-resistant versions of their products just as the drugs were about to lose patent protection.

In court papers filed in response to a lawsuit filed by Endo, the F.D.A. described the company’s action as a "thinly veiled attempt to maintain its market share and block generic competition." "(NY Times, 4/17/2013)

The FDA report on OxyContin and generics shared this statistic from the Congressional Budget Office: "Generic drugs save consumers an estimated $8 to $10 billion a year at retail pharmacies."

Are we safer with this new and improved version of OxyContin? No. Those who use drugs illegally will always find a way to get their fix. The whole controversy ignores the question of our need for strong narcotic painkillers and whether they’re being over prescribed.

The end result of this ‘safety’ reformulation will effectively shut out the generic drug producers for several more years. We, the consumers, will pay the price, out of our own pockets. Big Pharma wins again.

Comments for this article are closed.