Universal Healthcare Essay

The United States healthcare system has been set in motion for years, but it is still in a continuous state of evolution. The United States has a population of about 332 million people and they are supported by one of the most elaborate healthcare systems in the world. This system was formed by the provider, pays, and patients receiving the care. The U.S. healthcare system does not provide universal care, the government publicly financed Medicare and Medicaid. Paying out-of-pocket payments and different provisions of coverage as a means of financing and providing healthcare. As of now, we are one of the few countries on the wealthier side that do not have universal healthcare. Though the U.S. healthcare system is adequate for caring for a large

healthcare system uses pharmaceuticals as a way to treat patients and help providers. Approval is needed by the FDA before selling brands and generic pharmaceutical products in the United States. A pharmaceutical must go through a whole process to get approved. An application for a new drug (NDA) is first submitted to the FDA by its manufacturer. The goal of the NDA is to get FDA reviews and determine whether the pros outweigh the cons. If it is approved the quality and method have to be sufficient. The NDA package is delivered to CDER at the FDA to be further reviewed if the drug is genetics needs and Abbreviated New Drug Application (ANDA). That document provided the drug in dosages, strength, where to admit it, quality, its characteristics, and its intended use (U.S Healthcare System Overview). The Prescription Drug User Fee Act (PDUFA) had a major part in quickening the drug approval process by the FDA. PDUA first started due to the accumulation of new drug applications in the 1990s, it is made to help improve the FDA’s resources and ability to approve drugs within a decent time after they had been submitted. All drug manufacturers have to pay an application fee and program fees to submit an NDA to get a well-timed review by the FDA. Under PDUFA, the FDA is given 10 months to review an NDA, but ifthe FDA assigns priority review, the process is reduced to 6 months. Not all drugs are given priority review; it only happens when breakthrough treatments with no to few other options are out there. Upon the NDA, the FDA has 60 days to decide to accept or reject the document (U.S. Healthcare System Overview). Once a drug gets the approval letter the product can be marketed. Once marketed the product is reviewed and it will determine the access for individuals based on their coverage and reimbursement. Pharmaceutical payers in the United States do not regulate the price of the product, but there are pricing policies that the manufacturer uses when contracting