Heightened competition for pharmaceutical companies thanks to FDA

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Written by Alyssa Clark How will pharmaceutical companies be impacted by the introduction of the harsher Schedule II regulations by the FDA? What will...

Written by Alyssa Clark


How will pharmaceutical companies be impacted by the introduction of the harsher Schedule II regulations by the FDA? What will the implications from introducing this new Zohydro drug against the FDA advisory committee’s opinion?

From 1999 to 2010, the number of deaths involving opioid analgesics more than quadrupled, to nearly seventeen thousand, according to the Centers for Disease Control and Prevention. The FDA recently made front-page news this past October when it announced its decision to move commonly prescribed pain medications to the all-powerful Schedule II class of drugs. Now, drugs like Vicodin, over-the-counter painkillers and hydrocodone are not going to be available in their traditional forms, hoping to combat what has come to be known as “the prescription drug epidemic”.

The FDA promoted the use and manufacturing of a new drug entitled Zohydro ER, against a negative review from the FDA advisory committee. Beginning extensive trials in March of 2010, Zogenix recently introduced Zohydro ER as an abuse-resistant type of drug which is set to decrease the numbers of addicted patients and control overall distribution. The New Yorker described the medication as, “…an extended-release painkiller developed by a California-based company called Zogenix, which is made of pure hydrocodone and uses a higher dosage scale than hydrocodone-combination drugs like Vicodin”. Unlike those drugs, Zohydro ER does not include acetaminophen or aspirin, which can cause liver damage if abused over a long period.

Companies who manufacture the outstanding painkillers will be drastically impacted by the new up-and-coming drug, which is set to outshine the already in place drugs due to its cost-effectiveness, efficiency and overall patient-results. Not only will the introduction of the most-recently approved painkiller be problematic for businesses, but the overall competition within the pharmaceutical market will be at an all-time-high. These impending, stricter regulations will catapult the amount of intensive drug-screenings, and maybe this crack-down on prescription drugs is exactly what our society needs in order to cut down the unfortunate numbers of people affected by long-term painkiller abuse.

Issues like better-labeling, more intensified screenings, drug-warnings and precautionary advertising are other measures which have attempted to, but failed in decreasing this ever-growing epidemic. But the question remains— how does an institution deem one prescription drug as hazardous, and others equally as hazardous, as safe for public use?

Andrew Kolodny, a physician who has fought for stronger restrictions on pain-pill prescriptions, attended the December meeting as a member of the public and spoke up during a period reserved for comments. “One has to wonder how many more pain patients have to be harmed, how many more people have to become addicted, how many more lives will have to be lost,” he said, “before the F.D.A. finally begins to exercise its authority and responsibility to prohibit drug companies from marketing opioids as if they have been proven safe and effective for long-term use.”


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