Health Law, Administrative Agencies, and Anti-Discrimination

Health Law and Administrative Law Defined

Health law and administrative law are two legal domains that represent distinct yet overlapping approaches to classification, as discussed by Jost (2004). By definition, "health law encompasses law as it affects a particular industry — the health-care industry" (Jost 2004). This form of classification regulates the relationships among the various stakeholders in the healthcare industry, including, but not limited to, the government, patients, healthcare professionals, and healthcare providers. Administrative law, on the other hand, is defined by Black's Law Dictionary as "the law governing the organization and operation of the executive branch of government (including independent agencies) and the relations of administrative agencies with the legislature, the executive, the judiciary, and the public" (Jost 2004).

The Federal Trade Commission and Healthcare Competition

The three agencies examined here — the Federal Trade Commission, the Food and Drug Administration, and the Department of Justice — illustrate how administrative agencies interact with the healthcare industry.

As an independent federal agency, the Federal Trade Commission (FTC) concerns itself with the protection of consumers in an effort to foster a market that is both competitive and strong. It pursues this goal through the enforcement of antitrust laws and consumer protection laws. The relevance of competition in the healthcare market cannot be overstated: competition benefits consumers through cost containment, quality enhancement, and increased innovation. The FTC works to ensure that firms in the healthcare industry do not engage in anticompetitive behavior that could harm consumers. One of its principal antitrust enforcement policies concerns mergers and is designed to protect consumers from anticompetitive activity. It should be noted that while the FTC lacks the power to enforce its rulings directly, it may seek enforcement through the courts.

The Food and Drug Administration and Drug Regulation

The Food and Drug Administration (FDA) concerns itself with the regulation of health-related products and new food items entering the market. In doing so, it seeks to protect members of the public from ingesting, using, or consuming cosmetic products, drugs, and foods that could be unsafe or impure. One of the areas where the agency is most prominent is the regulation of new drugs, particularly during their development stage. To fulfill its mandate, the agency has established rules specifying mandatory new-drug clinical trials, and it closely monitors the testing of numerous drugs pending release in order to evaluate their effects on intended users. The FDA's influence over the pharmaceutical and biotech industry is therefore substantial. Upon its establishment, the law "authorized FDA to demand evidence of safety of new drugs, issue standards for food, and conduct factory inspections" (FDA 2015).

More information on the agency's regulatory framework is available through the FDA's legislative reference pages.

References

FDA (2015). Regulatory Information: Legislation. Retrieved from

Jost, T.S. (2004). Health Law and Administrative Law: A Marriage Most Convenient. 49 St. Louis U.L.J. 1, 1–34.