In The United States There Is a Lack of Medicines and Poor Supervision of Medication
<p><span style="line-height: 20.8px;">The Food and Drug Administration, charged with protecting the public health of American citizens, is facing threats that hinder their work. It is not capable of responding to the lack of remedies and procedures and the monitoring of withdrawals of medical devices are unclear. Moreover, globalization is also against them.</span></p>
Supervision of medical products added to the list of "high risk" of the US (GAO) in 2009. It happens that the body responsible for ensuring the welfare of citizens, the Food and Drug Administration (FDA), is facing a number of difficulties that threaten their ability to protect public health.
The role of the FDA is critical to ensuring health in the United States. The agency is responsible for monitoring the safety and efficacy of drugs, biological products and medical devices sold in the country.
However, the GAO says that they should improve some issues.
The Watchdog said that "the ability of the FDA to address drug shortages is limited by complications of management." The body not only as no systematic monitoring of the absence of remedies, but also has a set of performance metrics that are result oriented.
It should be noted that the situation is extremely important because in the absence of drugs, doctors must provide supplies, delay treatment or offer to patients taking alternative remedies, which may be less effective or may cause unwanted side effects.
One of the projects that helped the Food and Drug Administration to improve their situation in terms of lack of remedies was the Federal Food and Drug Administration Safety and Innovation, adopted in 2012. The law requires drugs manufacturers will notify the FDA, at least six months in advance- if they are planning on interrupting the production.
Another point is that the GAO noted that "procedures to monitor withdrawals of medical devices are unclear." These devices ranging from simple bandages and surgical tools like tweezers to pacemakers and heart valves.
If these products are defective or unsafe, the consequences can be severe, resulting in injury or death of patients. Faced with this scenario, the "FDA did not establish criteria for assessing whether companies should modify or suspend the devices off the market."
This situation is compounded by globalization, a major threat to the Food and Drug Administration. The dependence of medical products manufactured abroad increased scale, complicating efforts entity to ensure that they meet the expected quality levels.
In this context, the FDA took action to address this challenge and expanded its presence abroad. Thus, it sets up offices in Africa, Asia, Europe, Latin America and Middle East, to increase their knowledge of the standards used by regulators in countries that produce medical products, which are then destined for the United States.