Health Law and Regulation

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Health Law and Regulations

In understanding regulatory agencies the differences between regulation and legislation needs defining. Legislation is the law that has been passed by a voting process and regulation is the responsibility of the regulatory board appointed to enforce laws once the law is passed; it sets forth rules on how the laws are to be implemented and to what degree. In health care the Department of Health and Human Services (HHS) has the predominant responsibility to enforce legislation that impacts the health and well-being of Americans. Under the umbrella of HHS there are 13 regulatory agencies tasked with setting rules on the enforcement of the legislation passed by lawmakers. Regulatory Agencies

Two of the most influential regulatory agencies within HHS are the United States Food and Drug Administration (FDA) and the Center for Medicare and Medicaid Services (CMS), these two agencies have substantial influence on every aspect of health care delivery. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, medical devices, drugs, vaccines, blood products and biologics. In addition, they monitor medical errors and adverse reactions and reporting such to providers, (U.S. Department of Health and Human Services, 2011). CMS controls the Medicare program and works in collaboration with state governments to oversee Medicaid, and the State Children's Health Insurance Program (SCHIP). In addition to these responsibilities, CMS dispenses criteria from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), surveys and certifies quality standards in long-term care facilities, and clinical laboratories, (Centers for Medicare and Medicaid Services). The proportion of national health spending sponsored by both federal, state, and local governments was 45% in 2010, a significant source of revenue depended on by providers of health care, (Centers for Medicare and Medicaid Services, 2011). Current FDA Regulations

The Patient Protection and Affordable Care Act (PPAC Act), amended the Public Health Service Act (PHS Act) to create a shortened authorization route for medications found to be “highly similar” or “interchangeable” with an FDA-approved medication, (U.S. Department of Health and Human Services, 2011). The goal is similar to the Drug Price Competition and Patent Term Restoration Act of 1984 (“Hatch-Waxman Act”), which produced condensed methods for the approval of drug products under Federal Food, Drug, and Cosmetic Act (FFD&C Act). The outcome is aimed at the FDA’s instituted policy of allowing confidence on what is already known about a drug, thus protecting time and resources, (U.S. Department of Health and Human Services, 2011). To help increase access to affordable prescription medications, the FDA implemented measures to expedite the development and approval of generic drugs. Generic drugs cost 50 to 70% less than their brand-name counterparts equating to a savings of eight to ten billion dollars a year at retail pharmacies, (Crawford, June). These savings do not include the use of generic drugs in an institutional setting. PPAC expands on the practice of generic drugs and incorporates using medications that have the same efficacy as another more expensive medication leading to more options in the prescribing of medications. The practice of using generic drugs is not without concern. As evidenced by the case Pliva v. Mensing where the question was; the safety standards for brand-name drug labeling also apply to generic-drug manufacturers. The patients in the case took the generic drug metoclopramide and developed tardive dyskinesia, which was listed on the label. The patients argued the warning was not adequate and the manufacturer argued the “changes being effected” process was not available to generic-drug manufacturers because the FDA requires labels for generic versions of drugs to be identical...
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