The U.S. Food and Drug Administration (FDA) is the agency responsible for ensuring the safety and effectiveness of human and animal drugs, the food supply, biological products, medical devices, cosmetics, radiation-emitting devices and tobacco products.

Today the agency is facing major public health challenges brought on by the demands of the 21^st century. Science and technology are changing more rapidly and more dramatically and we must also deal with an increasingly globalized world.

The Commissioner has selected four areas to serve as strategic priorities over the next five years:

• Advance Regulatory Science and Innovation
• Strengthen the Safety and Integrity of the Global Supply Chain
• Strengthen Compliance and Enforcement Activities to Support Public Health
• Address the Unmet Public Health Needs of Special Populations

Advance Regulatory Science and Innovation

Over the next five years, the agency will create and implement a plan for expanding and modernizing the field of regulatory science. The FDA must possess a scientific capability to become engaged in mission critical fields of applied research, system biology, wireless devices, nanotechnology, imaging, robotics, regenerative medicine, and combination products.

Strengthen the Safety and Integrity of the Global Supply Chain

Some of the challenges presented by globalization are:

• Increased volume of imports
• Greater complexity of imported products
• More foreign manufacturers supply product
• Incomplete regulatory information about the product’s supply chain
• Lack of proper regulatory oversight of product safety
• Better chance for fraud
• Possible security threat
• Increased FDA workload
• Insufficient legal authority in some cases and lack of the proper enforcement tool

The growing challenges of globalization have far outstripped the nation’s budget for inspection and quality monitoring and the inability to maintain oversight. Addressing these challenges will require a shift to a focus on preventing threats or problems before they become issues. FDA will need more and better data about the product’s supply chain and better monitoring of that information during the product’s life cycle.

Strengthen Compliance and Enforcement Activities to Support Public Health

The FDA is implementing several new schemes designed to enhance its regulatory, compliance and enforcement systems. Some of those schemes involve establishing shorter time frames for industry to respond to inspectional findings, a process to prioritize follow up inspections after the issuance of a Warning Letter, a Recall, or other enforcement actions. FDA will work more closely with its regulatory and enforcement partners to share data. This increased collaborative approach will help to identify public health issues faster and enhance corrective actions.

Address the Unmet Public Health Needs of Special Populations

FDA will create a new Office of Minority Health to address challenges to reduce health disparities in the United States.

Phoenix, AZ is in the process of becoming the largest health-care data center in the world. The Institute for Advanced Health, when completed, will use fiber optics, wireless networks and “cloud storage” to create a central database to store patient information that would be accessible nationally and eventually globally. This datacenter will allow all sectors involved in the health-care industry such as research organizations, physician groups, hospitals, third party payers and patients to access releasable data more quickly to help make research or clinical decisions.

The Institute is expected to complement and grow the bioscience industry in Arizona and especially the immediate Phoenix area. It is expected that with the opening of the Institute the bioscience industry will see a huge expansions of job opportunities.

JE Hamilton & Associates is based in the Phoenix area and we agree that the Institute could possibly help increase Arizona’s standing in the research and biotech and health care communities.  The Institute for Advanced Health would allow more precision in prescribing the right medication at the right time for the condition at hand. It will allow hospitals to access pertinent data when a patient is admitted.  With the growing focus of biopharmaceuticals geared specifically for individuals, diagnosis with complete patient information is vital.  Overall, the system would allow for better patient care.

We welcome the Institute for Advanced Health to our Valley of the Sun and look forward to the positive benefits that will be available locally and the health care industry nationally.

There has been a lot of news lately about the unavailability of drugs used for execution in the United States. The drugs used are normally an anesthetic and a paralytic and then potassium bromide to stop the heart. The drug thiopental produced in the United States, an anesthetic, has been in short supply since some manufacturers have stopped producing it.

Most states that still permit executions and use the three drug method for execution have had issues with domestic supply of thiopental and searched for alternatives. The problem that importers are having with importation of that drug, and with others, is that they are not approved for any indicated use in the United States. While the domestic products are not approved for executions either, they have other approved uses.

In order to satisfy the FDA marketing requirements, the manufacturers of foreign products targeted for the domestic market, must comply with the approval process. This can be costly for a very small market return on investment.

Some states have since substituted for other FDA approved drugs which are available domestically. Regarding misbranding or labeling, none of the products were approved for execution.

In recent years, the FDA has expanded the use of investigational new drugs providing a lifeline to seriously ill patients who have exhausted all other options. Investigational new drugs are not yet approved for general use.  However, they are under research by clinical investigators and practicing physicians using subjects who have given their informed consent to participate.

Helpful Links:

• http://www.fda.gov
• http://www.phrma.org
• http://www.patientadvocate.org
• http://www.hospicepatients.org
• http://library.uchc.edu/departm/hnet/advocacy.html
• http://rarediseases.info.nih.gov/
• http://www.cms.gov