Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The new health care reform bill gives senior citizens a rebate to purchase prescription medications; however, increasing availability of drugs for seniors may cause safety concerns, especially when it comes to generic versions of medication, according to a Huffington Post blog by Edward F. Blizzard.

“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,” Blizzard writes.

When it comes to generic drugs, Blizzard says the FDA’s current method is “badly flawed.” Here is why: When prescription drugs are approved by the FDA, they receive a patent, which stalls competition for a certain number of years in order for the company to recoup expenses incurred while developing the drug. During this time of free reign, the drug company must track and report adverse events and data to the FDA. Once the patent expires, competing manufacturers can market generic alternatives to the brand-name medication. These generic drug makers are required to report any adverse events or data to the FDA, but many fail to do so. In the end, it is the consumer who suffers.

For example, generic manufacturers of the acid reflux treatment Reglan (metoclopramide) failed to adequately monitor adverse events in patients taking the drug. The drug carries a risk of a serious involuntary movement disorder, Tardive Dyskinesia. Prolonged use – more than 12 weeks – raises one’s risk of developing the condition fivefold. It wasn’t until February 2009, after numerous people became ill, that the FDA issued a black box warning on Reglan and its generic alternatives.

“For too long, generic manufacturers have marketed potentially deadly products without regard for the long-term safety of their products,” Blizzard continues. “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.”

Related posts:

• Ruling: patients may sue generic drug makers under state law
• Acid reflux drugs provide temporary relief but can cause adverse reaction
• Diabetic gastroparesis treatment shows well in clinical trials
• Supreme Court considers whether generic Reglan makers can be sued
• Using Reglan can make you depressed

This entry was posted on Friday, April 16th, 2010 at 9:58 am and is filed under News. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.