1. What is the eCTD format? Briefly explain its importance to the global regulatory affairs profession for marketing approval of new pharmaceuticals (medicines) and biologic (biotechnology) products.

The electronic common technical document (eCTD) format is the submission structure for new entrants and exiting companies that supply drugs and medicines on the global market. The format is categorized into five sequential groups, namely, administrative and prescribing information, common technical document summaries, quality, non-clinical study reports, and clinical study reports (Ahammad et al., 2019). The fundamental aim of the eCTD format is to enhance the process of regulatory reviews of global drug development, ease tracking and accessibility of documents, and minimize risks of duplicate or missing documents in the pharmaceutical and biologics industry.

2. Briefly describe one difference between the way the US FDA regulates cannabis and the way Health Canada regulates the use of cannabis products in Canada.

While Health Canada permits Canadians to use marijuana for recreational purposes, the same body hinders individuals from using cannabis for therapeutic reasons. However, the US FDA permits Canadians to use cannabis for recreational and clinical purposes; hence, permitting industries to manufacture cannabinoids that place consumers' health at risk.

3. What is Real World Evidence (RWE), and why is this type of evidence increasingly becoming a critical component of the FDA's evaluation of a biomedical product's performance from a clinical perspective?

Real World Evidence (RWE) is the proven evidence regarding the use, prospective benefits, and risks of a medicinal product derived from analysis of Real World Data. RWE is increasingly becoming a vital component of the FDA’s evaluation of a biomedical product’s performance from a clinical perspective such as making informed Food and drugs regulatory decisions through monitoring post-market safety and adverse instances such as food poisoning (Suvarna, 2018). Besides, the FDA uses RWE derived from RWD to develop clinical trial designs among medical product developers. In addition, the healthcare community uses RWE to support coverage decisions, develop decision support tools for use in clinical practice, and enhance public safety by allowing the development of safe drugs.

4. Who is the current commissioner of FDA (Name)? Briefly describe one significant modification that this individual has announced or implemented to FDA regulatory process during this year.

Janet Woodcock is the current commissioner of the FDA. The Coronavirus Response and Relief Supplemental Consolidated Appropriations Act of 2021 is the new amendment of the Coronavirus Aid, Relief, and Economic Security Act that was enacted to offer immediate response to the Coronavirus pandemic (Voet, 2020). The new act involved the $55 million allocation for FDA that addresses the relief strategies and governmental efforts and response in combating the endemic.

5. How does US FDA regulate products containing cannabidiol (CBD)?

The US FDA regulates products containing Cannabidiol (CBD) by setting litigation, which limits the production, sale, and distribution of products that contain cannabis or cannabis-derived compounds. The FDA enlists and treats cannabis or cannabis-derived compounds the same way as any other FDA-regulated product. The Agriculture Improvement Act of 2018 added hemp to drugs that contain cannabis or cannabis-derived compounds; hence limiting hemp consumption and fostering consumer safety (Voet, 2020). Besides, US FDA, through litigation, hinders companies that claim to produce drugs Cannabidiol (CBD) for treating life-threatening ailments such as cancers.

6. Please briefly describe the importance of the Biologics Price Competition and Innovation Act passed by the US congress in 2010 to biosimilar manufacturers.

 In the year 2010, president Barrack Obama passed the Competition and Innovation Act targeting to lower the prices of medicines by introducing biosimilars in the healthcare sector. The BPCIA act legalized the production of generic versions of drugs produced by biotechnological means; hence, increasing the number of drugs produced and addressing the high demands of medicines in the health sector (Group, 2016). When the availability of drugs on the market increase, the prices charged drop; hence, ensuring that drug sellers offer sale the product at consumer-friendly prices. Initially, biosimilar manufacturers produced and availed drugs to consumers at costly prices that hindered low-income earners from purchasing the drug. Therefore, the BPCIA act allowed companies to produce generic drugs that increased the number of medicines on the market; hence, lowering the amount of price of medicines to consumers.

Essay Questions

1. As we discussed in Module 3. there are conflicting opinions regarding the historical effectiveness of the FDA’s regulatory pathway for manufacturers to obtain marketing approval for new biosimilar therapeutic products. In 2-3, paragraphs please explain your own opinion as to why FDA’s marketing approval process for new biosimilar products Is or Is not effective? As part of your answer please include an assessment of regulatory and other types of variables that both proponents, as well as opponents, of the process, have used to describe their own opinion. Should FDA’s biosimilar therapeutic marketing evaluation process remain the same, or do you believe it should be modified in some way?

The FDA’s marketing approval process for the new biosimilar product is effective as the process uses the standalone technique to determine the safety effectiveness and potency of the biosimilar drug. Patient safety coupled with the need to offer quality care and effective treatment is the fundamental role of the FDA (Voet, 2020). In my view, the standalone technique measures the biosimilar drug’s clinical trial for the ailment’s indication being sought by the manufacturer. However, I have a divergent opinion that the standalone marketing approval process that FDA uses can potentially harm patients if biosilimarity is not kept under consideration. The FDA’s failure to acknowledge the clinical and pharmaceutical composition of the biosimilar drug to the reference medicine results in the approval, sale, and distribution of biosimilar drugs that harm patients due to unmeasurable side effects and the harmful nature of the drug.

 In my opinion, the FDA should modify the biosimilar therapeutic marketing evaluation process to assess clinical trials and pharmaceutical composition based on the reference drug to determine biosimilar drug’s effectiveness, safety, and potency to patients. The standalone technique used to determine the potency, effectiveness, and safety of the biosimilar drugs is less effective and exposes clients to health risks such as adverse side effects. Therefore, when FDA’s biosimilar therapeutic marketing evaluation process is modified to include clinical and pharmaceutical trials to the reference drugs, patients are availed with safe and quality biosimilar drugs that are effective in treating myriad ailments.

2. Do you believe it is possible for FDA to accelerate its current new pharmaceutical and/or biologic approval process without compromising patient safety? If so, how can this be done? If not, Why?

The FDA should modify its current pharmaceutical or biological approval processes without compromising patients’ safety. The successes of the FDA’s approval processes lie in how effective the regulatory body uses the Real World Evidence from the Real World Data regarding the biological and clinical interactions of drugs with patients. Since new ailments are introduced in the health sector daily, the FDA should review the number of new diseases and incorporate them into the already developed approval processes. However, in my view, new aliments lack reference drugs before approving the biosimilar drugs or clinical drugs. In such situations, the FDA should conduct extensive clinical trials to determine the side effects, safety, potency, and effectiveness of the drugs to patients as such tests eliminate the health risks that the new drug poses to patients.

            Besides, the FDA should also conduct a review on the effectiveness of the new drugs on different patients. The drug interactions on patients vary depending on the body’s ability to fight the disease and blood groups (Group, 2016). As such, the FDA should conduct extensive research to determine individualized effectiveness, interactions, and side effects of a newly introduced drug targeted to cure a new ailment. In so doing, patients safety is guaranteed since the FDA constantly provides new approval guidelines of drugs as new aliments emerge.