The Food & Drug Administration (FDA) has recently proposed guidelines to make it easier for Americans to obtain high-risk drugs without ever seeing a doctor. According to the four-page proposal, the FDA suggests that certain types of prescriptions drugs be made available over the counter.
Included in the proposal are cholesterol, or statins, diabetes, and asthma drugs, among others. The reason, according to the FDA, is that too many patients are not getting their prescriptions filled. Also, many potential patients are not going to see doctors to receive treatments allegedly needed.
The new proposal has received criticism that the drug companies are behind it. According to the criticisms, the drug industry is losing profits due to heightened regulation and an alleged lack of patient participation in the medical arena. Reports have arisen alleging the FDA is working with big pharmaceutical companies to support the proposal.
However, others in the medical community are alarmed at the proposal. According to these reports, the FDA has not backed up its new suggestions with medical evidence, to show that patients are able to self-diagnose and manage these medical conditions on their own and without going through a doctor. The FDA supports the proposals as removing unnecessary obstacles that prevent Americans from managing their own healthcare.
The FDA found that an estimated 20% of prescriptions in America go unfilled. The cost and time it takes to go to a doctor, says the FDA, may be a big factor in this statistic.
Part of the issue lies with the fact that, as the defective drug lawyers at JONES WARD PLC know, big pharmaceutical companies often push profit over safety, so anything they suggest in the drug regulatory regime is likely going to be for their financial benefit. As the gatekeeper of prescription drugs, it is the FDA's role to keep the drug companies in check, and to prevent profits over safety from becoming the defining policy of the drug industry. If the FDA and big pharma are truly working together for a common goal to decrease drug oversight, this blurs the line between regulator and the regulated.
Whether you are on either side of the issue, it will be a while before the proposals get approved or denied, it is still in its formative stage. The FDA is currently requesting comments on the issue.
The defective drug lawyers at JONES WARD PLC are dedicated to brining you the most up-to-date prescription drug information as it comes out. Our nationwide pharmaceutical practice aims to help those who have been injured by dangerous drugs and medical devices. If you or a loved on has been injured by a defective drug, please give us a call. For more information, contact attorney A. Layne Stackhouse at 502.882.6000 or email@example.com.