To help speed up the lengthy clinical trials process for new drugs, the Pharmaceutical Research and Manufacturers of America (PRMA) proposed a plan to enable the submission of electronically signed documents, or "signatures". The proposal was not well received by the US FDA, who at first declined to regulate the use of electronic signatures as a proof of identity for medical claims. The American Medical Association and the American Association of Clinical Endocrinologists opposed the move, warning that it would enable fraudulent use of medical claims in the treatment of human diseases. It was not surprising that the FDA failed to pass the initial restriction, as the medical professions and pharmaceutical industry was busy in devising ways to protect themselves from these new technologies. However, when the New Drug Application became approved in June 2002, the FDA went back on its decision, proposing amendments that would allow biometric authentication of the medical claims made by the pharmaceutical manufacturing and pharmaceutical companies. Initially the new regulations required only that biometric information be recorded on the electronic health records (EHRs). Later, the FDA proposed to add provisions that would allow the use of electronic signature in filling out forms for new drugs, and for filing medical information. This time, however, the amendment allowed biometric data to be used to control authorization and to track and monitor the completion of long-term EHR projects. The pharmaceutical companies were not content to let this happen, and began a campaign to fight for more data security and EHR reform. The American Association of Clinical Pharmacy was particularly active in this debate, claiming that the EHR vendors were failing to protect the confidential data of their clients. Even with the FDA's revisions, the pharmaceutical companies were not entirely satisfied with the safeguards provided by the EHR and remained suspicious of the motivations of the FDA and pharmaceutical company officials. Many industry observers believe that pharmaceutical companies may eventually sue the FDA over the regulations limiting data security. Get more enlightened on the continuing education for pharmaceutical manufacturers here! Concerned parties in the pharmaceutical industry have also been exploring the possibility of developing generic drugs in an effort to reduce costs. Generic drugs are expected to cost less than those treatments designed specifically for each patient, as well as to have the same effectiveness as expensive brand-name drugs. However, these generic drugs may not be effective against some of the costly diseases affecting patients and physicians. There have also been suggestions that generic drugs may not be safe, and could possibly cause more harm than good to patients using them. The Pharmaceutical manufacturing Association has been critical of the process of biotechnology and other innovative pharmaceutical manufacturing methods, arguing that the companies are not providing data that is reliable enough to support the claims they make about their drugs. Biotechnology, for example, has been criticized for producing "clustered" or genetically engineered organisms. These organisms are not approved by the FDA and may not have the same safety and efficacy as their natural counterparts. The Association contends that the FDA should require the companies to provide more information before issuing approvals. The Biotechnology Industry Organization, another trade group, has filed a lawsuit against several biopharmaceutical companies, arguing that they are improperly controlling the genetic and environmental environments of cells used in biotechnology research. Both groups believe that the Biotechnology Industry Organization is acting inappropriately in trying to regulate the biotechnology industry. Manufactures argue that they cannot adequately control the use of antibiotics, growth hormones, medications, and other biotechnology products in the manufacturing phase of the pharmaceutical process, but they do not believe that the FDA has the authority to prohibit them from doing so. Currently, there are legal loopholes that allow biopharmaceutical plants to continue using these technologies, even though the science behind them is not fully understood. If these manufacturers lose access to the exclusive intellectual property rights associated with their technologies, it may be difficult for them to continue to manufacture the pharmaceuticals that they need, although it is unlikely that any manufacturer would go out of business due to these legal issues. Add on to your knowledge about this topic, by visiting this link: https://en.wikipedia.org/wiki/Approved_drug.
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