Draft an articulate response to a students discussion board post. Here is the post you are responding to:
Hello everyone,
The pharmaceutical industry is influenced by several factors within the political, economical, social, technological, legal, and environmental sectors. One of the most significant factors which impacts and shapes the operation of the pharmaceutical industry is the political factor.
Our government has held a role in the pharmaceutical industry dating for nearly 150 years. “Since 1879, nearly 100 bills had been introduced in Congress to regulate food and drugs; on 30 June 1906 President Roosevelt signed the Food and Drugs Act . . . a pillar of the Progressive era†(“Part I: The 1906 Food and Drugs Actâ€, 2019, para. 1). The Food and Drugs Act served to regulate the labeling standards on food and medicinal products which were made available for sale to the public.
In 1938, Congress passed the Food, Drug, and Cosmetic Act to replace the original 1906 Act. This revised Act was passed in response to a health disaster in 1937, in which over 100 people died after taking a new sulfa elixir whose solvent had a highly similar chemical composition to that of antifreeze; the elixir had not been tested before being released to the market. “The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold†(“Part II: 1938â€, 2018, para. 4-5). Both Acts were initiated due to concerns that food and medicinal products were not being packaged, labeled, or marketed properly for the safety and well-being of the consumer. Without regulations and government oversight, drug makers were producing drugs and releasing them for patient use without the appropriate testing to ensure their safety and efficacy. This was oftentimes generally done for the financial gain of the drug company, not the well-being of the patient. The government stepped in to ensure standards of safety for all patients by requiring rigorous testing and clinical trials on new drugs.
As we fast-forward several decades to the present day, we will notice that politics and government regulation play an ever-present role in the pharmaceutical industry. The Food and Drug Administration continues to oversee the clinical testing and approval of new drugs to ensure that drugs are effective and safe for patients before being released to market. Additionally, the federal government has put increased emphasis in lowering prescription drug prices during recent years. The United States’ 2020 budget emphasizes lowering drug prices as a fiscal goal in order to reduce this significant burden on patients. “[T]he 2020 Budget proposes strategies targeted at increasing competition, encouraging better negotiation, incentivizing lower list prices, and lowering out-of-pocket costs for beneficiaries†(“Lowering Drug Pricesâ€, 2019, para. 1). One of the specific goals highlighted in the 2020 Budget is the aim to revamp the cost-sharing arrangement that many patients have with their insurance payers. This will increase patient’s abilities to afford the out-of-pocket payments on their medications; this in turn will translate into better medication compliance and stronger health outcomes.
Another goal of the United States’ 2020 Budget is to “address abusive drug pricing by manufacturers†(“Lowering Drug Pricesâ€, 2019, para. 9). The primary reasoning behind this goal is to reduce medication costs and increase patient access by rendering medications more affordable. Dozens of new drugs have been released to market in recent years; however, because of their exorbitantly high costs and frequent refusal of insurance companies to cover the cost, many patients must either struggle to locate and secure copay assistance or simply go without the medication.
Unfortunately, political and government-related activities are often improperly influenced by lobbying efforts on part of pharmaceutical companies. “[L]obbyists for the drug industry contributed a record total of nearly $282 million in 2018. These big spenders primarily target lawmakers who lead committees that oversee health care and drug policy†(Kellner, 2019, para. 11). This improper use of money to sway the actions of lawmakers is done for the benefit of the drug industry and not the patient; it is primarily done to drive activities which will bring profit to the drug companies.
References:
Kellner, J. (2019). Big Pharma, Bigger Money in Politics. Retrieved from https://americanpromise.net/blog/2019/04/30/big-pharma-bigger-money-in-politics/
Lowering Drug Prices: 2020 Budget Fact Sheet. (2019). Retrieved from https://www.whitehouse.gov/wp-content/uploads/2019/03/FY20-Fact-Sheet_Lowering-Drug-Pricing-and-Payment_FINAL.pdf
Part I: The 1906 Food and Drugs Act and Its Enforcement. (2019). Retrieved from https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-i-1906-food-and-drugs-act-and-its-enforcement
Part II: 1938, Food, Drug, Cosmetic Act. (2018). Retrieved from https://www.fda.gov/about-fda/fdas-evolving-regulatory-powers/part-ii-1938-food-drug-cosmetic-act
