News & Resources

May 29, 2012. Category: Unsafe Drugs

FDA Proposal Puts Patients at Risk by Eliminating Physician Oversight

A new FDA proposal to change the classification of several prescription medications to over-the-counter (OTC) status seems to put pharmaceutical companies’ profits before patient safety. The FDA’s apparent goal is to ease access to medications for chronic medical conditions such as high cholesterol, diabetes, and asthma by eliminating doctor’s visits, under its new concept of “self-care.” Instead of having to visit a physician to get a prescription, patients could just go to a local pharmacy to get a medication after completing a computer questionnaire. This program will undoubtedly increase profits for pharmaceutical companies, but the lack of physician oversight for serious chronic medical conditions puts patient’s safety at risk since patents would essentially be self-treating their conditions.

The AMA (American Medical Association) recently took to the editorial page of USA Today out of its serious concerns regarding the FDA’s proposal. Writing on behalf of the AMA, physician Peter W. Carmel stated his fear that, “Without physician involvement, patients might take the wrong medication or dose for their needs, potentially causing harm.” Dr. Carmel also argues that the FDA has provided no evidence that the technologies behind the new program would allow patients to safely monitor or manage their medical condition on their own.

Another problem with the FDA proposal is that it really does not decrease the cost of treatment. When the FDA changes a drug to OTC status, insurance usually stops covering the medication. Patients usually end up paying more since they must cover the full-cost of the OTC medication themselves.

Historically, the FDA has a long track record of failing to properly monitor, oversee, and regulate drugs and medical devices. Time and again, consumers are the ones who suffer. From unsafe drugs and medical products allowed on the market (recent examples include the blood-thinner Pradaxa, pelvic mesh products used in female surgeries, and metal-on-metal hip implants) a lack of government oversight has decreased safety for consumers. Simply put, the FDA’s new proposal is a bad idea. Eliminating the protections that come from having a physician prescribe medication will put a massive number of patients’ health and safety at risk.


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