Health Law Regulations in 21st Century Term Paper

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Food and Drug Administration, a United States federal agency, with regards to its major effects in the health care industry. Two examples of healthcare laws that are enforced by the Food and Drug Administration are also given. This paper will also discuss the effects of these healthcare laws on several specific healthcare providers.

The Food and Drug Administration (FDA)

The FDA is an agency of the United States federal government that is mandated by law to protect public health. Its tasks comprise ensuring that human and veterinary drugs, medical instruments, food supplies, cosmetics, radioactive substances, and biological products in the United States are not only effective, but are also safe for human and animal use. The agency is tasked with enabling advances in public health by providing assistance to speed up innovations that help make pharmaceutical medicines more affordable, safer, and more effective. The agency is responsible for ensuring that the citizenry gets accurate, and factual science-based information concerning foods and medicines so as to maintain and improve the well-being of the public (What We Do). The agency is tasked with regulating the process of manufacturing, advertising, and distribution of cigarettes and other tobacco products, so as to protect public health, and to reduce the use of tobacco by minors. Finally, and perhaps more importantly, the FDA is a significant component of the U.S.' counter-terrorism strategy. In this respect the agency is responsible for securing the nation's food supply, and is involved in the development of medical products that can be used to counteract malicious man-made or naturally emerging public health threats.

Laws Enforced

One of the major healthcare laws that are regulated and enforced by the Food and Drug Administration is the Pure Food and Drug Act of 1906. The act set a number of important rules and regulations regarding medicines, including the legal definitions of drugs, establishment of standards, and rules addressing mis-branding. Moreover, the Pure Food and Drug Act stated that laws and policies regarding the buying and selling of mis-branded or adulterated local medical products across State lines were to be applied equally to imported drugs. This law was to be implemented by the Bureau of Chemistry in the Department of Agriculture (Worthen, 2006). The term 'drug' was defined in the Act as any preparation or medicine that is recognized by the National Formulary, or the United States Pharmacopeia, for external or internal use. Drug was also defined to include any mixture and/or substance that was intended for use in prevention, mitigation, or as a cure for a disease that affects either humans or animals. The Pure Food and Drug Act of 1906 also established the legal standards that all kinds of medicines were supposed to meet, with regards to purity and labeling accuracy. James Hartley Beal, who was the President of the American Pharmaceutical Association in 1905, and chairman of the United States Pharmacopeia (USP) Board of Trustees, was influential in the inclusion of the National Formulary (NF) and the USP as the official standards in the definitions of drugs in that particular piece of legislation (Worthen, 2006).

The Food and Drug Administration Safety and Innovation Act (FDASIA) that was recently signed into law by President Barrack Obama is another public healthcare law that is regulated and enforced by the FDA. The final draft of the law was reached after lengthy discussions among legislators, regulators (FDA), industry representatives, and patients' advocates. The main objective of this particular legislation concerned the review process for drugs and medical devices before they are marketed. The law also covers the issue of user fees.

The law for instance caters for an accelerated approval process for drugs that target life-threatening conditions. The FDASIA Act mandates that the FDA regard therapeutic, pathophysiological, epidemiological, or other scientific evidence as clinical end points in the study of these drugs. In the clinical products market, many industry representatives have often cited inefficiencies in the evaluation of healthcare devices by the FDA as an obstacle to bringing innovative clinical products to the market (Kramer and Kesselheim, 2012). Regarding this point, the FDA in its websites describes the FDASIA as new legislation that represents the commitment between the agency and the American medical device industry to increase efficiency of the regulatory processes and approvals and to cut the time taken for the products to reach the market.

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For example, this legislation states that by the year 2016, the FDA must give decisions on approvals, or otherwise, within 90 days for 95% of devices under study. This process uses the 510(k) process for moderate risk clinical devices, which only requires manufacturers to demonstrate or prove that the device is significantly equivalent to a device that has already been approved by the FDA (Kramer and Kesselheim, 2012). In recognition of the huge growth of information technology (IT) in healthcare, the new Act mandates the FDA to formulate, within 1 and a half years of the enactment of the Act, a strategic regulatory framework for IT regulation. This framework is intended to not only protect the safety of the patient, but also to promote innovation, and inhibit regulatory duplication (Kramer and Kesselheim, 2012). This framework is expected to include medical smartphone applications, a field that is currently experiencing rapid growth and ambiguous regulations, in spite of the significant potential health risks to patients.

The CDRH and Abbott

FDASIA has mandated the Center for Devices and Radiological Health (CDRH) to avail to an applicant a comprehensive summary of the regulatory and scientific rationale used for making any significant decisions pertaining premarket approvals, IDE applications, or regarding 510(k) submissions (Gibbs, 2012). The summary must entail a documentation of key issues that are controversial, or are areas of differing opinions, as well as addressing the resolution of such issues. After receiving these documentations, the applicant has the power to appeal a harsh "significant decision." Such an appeal must be lodged before 30 days have elapsed. Upon the receipt of the appeal, the CDRH has 30 days to schedule an appointment with the applicant. After the hearing, the CDRH has 30 days to give its decision regarding the matter (Gibbs, 2012)

With regards to these legislations, Abbott Laboratories Inc., Roxane Laboratories Inc., and B. Braun Medical Inc. And their affiliates, agreed to pay $421 million to settle violations of the Pure Food and Drug Act of 1906. These payments were penalties to resolve claims by the federal government that the defendants (the above mentioned pharmaceutical companies) engaged in a scheme to falsify and report inflated prices for many pharmaceutical products knowing that this information was relied upon by federal healthcare programs to set payment rates. The real sale prices of the pharmaceutical products were far lower than what the defendants had reported. Abbott laboratories agreed to a settlement amount totaling $126.5 million to resolve the matter (Pharmaceutical Manufacturers to Pay $421.2 Million to Settle False Claims Act Cases). The above case was first been filed in Southern District of Florida, before it was later transferred for a pretrial hearing in the District of Massachusetts. In this case the Justice department alleged violations by the Abbott laboratories of the False Claims Act, pertaining to pricing of its sterile water, dextrose solutions, vancomycin, and sodium chloride solutions. The sterile water, dextrose solutions, and sodium chloride solutions are generic water-based solutions essentially used to facilitate the injection of other drugs.

Seen in Life/Community

The Food and Drug Administration Safety and Innovation Act authorizes the collection of user fees from medical device companies every fiscal year . As was before this Act was operationalized; there are annual increments in the user fees. The types of fees to be paid have remained the same, although there is notable increase in the number of parties that have to pay registration fees. Personally, I have a close relative who is partially deaf; he has to use a hearing aid that is in the form of a medical implantation device. At times, I have wondered how his life in the long run would be affected by the new FDASIA law. Perhaps, one benefit is that new medical devices could be approved more quickly to alleviate his problem. This new law is likely to impact the fees that he pays personally and to affect his health insurance and co-pay fees as well as having an impact on fees that the device company will have to pay have come up due to the new health law. Even though there are some costs to worry about, individuals like my relative and others who are suffering from even more severe health conditions can have life-saving medication faster, courtesy of the new.....

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