The Food and Drug Administration (FDA) has been responsible for ensuring the safety and effectiveness of medications since its establishment in 1930. Following amendments to the federal Food and Drug Act (FD and C) in 1962, the safety and efficacy of new treatments have been evaluated, establishing the standard of evidence for the Drug and Cosmetic Act (FD and C).^1–3 In 1906, the United States Congress established the first federal drug laws, which prohibited the sale of drugs that were mislabeled or contaminated, as well as food and drink. Later, in 1938, the federal government passed legislation that ensured medication safety before being sold.¹ This was followed by the Kefauver-Harris Drug Amendment of 1962, which further strengthened drug safety regulations. The Orphan Drug Act of 1983 represented a significant change in approach, as it aimed to encourage the development of drugs for rare diseases.¹ The Act provided seven years of exclusive commercial rights for clinical research, tax rebates and other financial incentives. Cutting prescription costs by using generic drugs is one important way for individuals to save money. The Hatch-Waxman Act of 1984 protects the rights of brand-name drugs while promoting the production of generic drugs. ClinicalTrials.gov was established in 1999 to inform patients about ongoing clinical research. In a 2004 article titled “Innovation or Stuckness: Restrictions & Possibilities regarding the Crucial Route to Novel Medicinal Products,” the FDA highlighted the need for collaborative efforts to improve the evaluation, development and manufacturing of healthcare products. We have made additional changes to our system while keeping patient safety and satisfaction as top priorities. With the recent increase in the speed of drug approvals by the FDA, we want to analyze the approval trends of new pharmaceuticals in the last five years and understand the reasons behind them. As influential healthcare professionals are prescribing and using these new medications, it is recommended that primary care physicians acquaint themselves with them.

Step 1: Research work in a laboratory is currently underway to study the efficacy of a new medication.

Step 2: “Drugs undergo testing in laboratories and on animals to gather fundamental safety information.”

Step 3: To confirm their effectiveness and safety, drugs are tested on human subjects.

Step 4: FDA review teams meticulously evaluate all information provided on a medicine or device before deciding whether to approve it.

Step 5: After a product is approved for public use, the FDA monitors the safety of all medications and devices.

The US FDA is responsible for evaluating and approving new drugs and therapies for public use. This involves conducting thorough clinical trials to assess the safety and effectiveness of these products. Additionally, the organization is responsible for monitoring the safety of medications and addressing any complaints regarding negative effects after approval.⁵

Throughout the process of viral infection, replication and viral discharge, the DNA of the virus gets integrated into the host cell. The virus’s life cycle consists of six stages: adhesion, invasion, uncoating, replication, assembly and virus release. This section provides an overview of the virus’s life cycle, emphasizing its entry and exit. During the attachment and penetration phases, the virus adheres to a host cell and introduces its genetic material into it.⁷ During the next stage of the virus’s life cycle, any viral DNA or RNA is mixed with the genetic material of the host cell. This mixing process causes the host cell to copy the viral genome. At this point, the virus undergoes assembly, reproduction and uncoating. The newly created viruses are released after the host cell dies or multiplies through the cell membrane, causing the host cell to burst. This process is essential for the survival and proliferation of the virus.⁸

The study gathered data from the FDA’s online database on innovative medicine approvals between 2019 and 2023. The CDER’s annual report lists all new medications authorized in a specific year, including any new evidence of FDA approval. The drugs in the report are divided based on several criteria, including the number of medications authorized each year, the pharmaceutical class, the patient demographic, the type of permission obtained and/or faster approvals.

Out of the 216 new pharmaceuticals approved in the last five years, just 24 are biologics. According to these results, fewer Investigational New Drug Applications (INDAs) are being filed under the antiviral and antibiotic categories. Research and development initiatives undertaken by the pharmaceutical business may be focused on alternative therapeutic areas or may arise from a New Chemical Entity’s (NCE) failure in the early stages of development. Antivirals from 2019 to 2023 are listed in the Table 1.

CDER works in partnership with the pharmaceutical industry to innovate drug discovery and development.

CDER provides comprehensive support for the production and testing of drugs, as well as understanding the science of illnesses for the FDA. CDER is crucial for bringing creativity to the drug development process and approving new drugs and biological products. These include both brand-new drug classes and drug classes that share modest structural changes. Obtaining FDA permission for a new medication is a challenging process. Compared to previous years, the approval rate for medicines has increased dramatically. We have seen that, for the most part, medical needs and sickness trends remain rather constant. The pharmaceutical industry is intended to be supported by information derived from fundamental research and unmet medical needs. Act of Intent to try. India will eventually adopt the US Food and Medicine Administration’s (USFDA) medicine approval process, as we have not made any progress. However, given the incidence of disease in our nation, which mostly consists of infectious diseases like malaria and tuberculosis, along with cancer, diabetes and hypertension, the number of new medications approved by the US each year still falls short of the unmet demand in our country. Primary care physicians have been known to prescribe novel drugs like dabigatran, sitagliptin and aliskiren in the past, in addition to obtaining instruction from their peers.¹⁶ These days, a lot of people visit primary care clinics for further treatments or infusions after receiving a cancer or autoimmune diagnosis. Therefore, “It is crucial for primary care physicians to stay up-to-date in their practice.” up to date on new drug approvals as well as creative applications for existing approved treatments.

Figure 1:
Drug development process.⁴

Figure 2:
New Drug approval process as per USFDA.⁶

Figure 3:
Drug review process.⁹

Figure 4:
Total number of approved drugs from 2019-2023.¹⁵

Figure 5:
Total number of Rejected anti-viral drugs during 2019-2023.

According to Section 201(g)(1) of the FD&C Act, homeopathic goods are defined as “drugs” that are recognized in the Homeopathic Pharmacopeia of the United States (HPUS) or its supplements. Hence, they are required to meet all regulatory standards such as those related to adulteration, misbranding and FDA clearance, similar to conventional medications.

Noble Elements, LLC: The FDA evaluates new drugs based on scientific evidence that confirms their effectiveness and safety. According to sections 301(d) and 505(a) of the FD&C Act, new medications cannot be legally introduced into interstate commerce without prior FDA approval.

Purecraft, LLC: Our analysis indicates that these products violate Section 505(a) of the FD&C Act, as they are unapproved new drugs. Additionally, they are considered misbranded drugs, which violate Section 502 of the FD&C Act. As per FD&C Act sections 301(a) and (d), the introduction into interstate commerce, or the manner thereof is prohibited.

Iodine Products Inc. is distributing unapproved and novel drugs which violate Section 505(a) of the FD&C Act. These products are also considered misbranded drugs under Section 502. It is illegal to introduce these products into interstate commerce, as per Sections 301(a) and (d) of the FD&C Act.

“According to our analysis, the products being distributed by Viraldine, LLC are innovative but unapproved drugs, which violate the FD&C Act, particularly Section 505(a). These products are also classified as misbranded drugs under Section 502. As per Sections 301 and (d) of the FD&C Act, it is illegal to introduce these products into interstate commerce or to deliver them for introduction.”

Kaleido Biosciences, Inc. has responded to Form FDA 483 by stating that it is in the process of creating a protocol to consult with the FDA about whether an IND (Investigational New Drug) is necessary when developing clinical studies for a group of patients whose endpoints may be interpreted as identifying, reducing, treating, preventing or curing a disease. However, we are unable to determine whether Kaleido’s plan to address the issue is adequate in the absence of more details.¹⁸

Kaleido Biosciences, Inc. responded to Form FDA 483 by stating that they are working on a protocol with the FDA to determine if an IND is necessary when developing clinical study plans for a patient population. This will help them determine if their endpoints may be interpreted as diagnosing, mitigating, treating, preventing, or curing a disease. However, without more information about this protocol, it is difficult to determine if Kaleido’s corrective action plan will effectively prevent future violations.¹⁹

Sovereign Laboratories, LLC produces products that are identified by MARCS codes and they are categorized as oral spray products.

These products are not considered dietary supplements under Section 201 of the FD&C Act because they are intended to be ingested through the mucosal tissues at the back of the throat. They are not classified as foods or dietary supplements.²⁰

The COVID-19-related products from BGP, LLC and Halodine, LLC are denied because they are unapproved innovative drug products. In addition, the FD&C Act’s Sections (ee) classify them as misbranded drugs. The FD&C Act’s Sections 301 and (d) forbid introducing these goods into interstate commerce or delivering them for introduction.²¹

In terms of the USFDA’s rejection of antiviral medications, in 2023 there were only 4 rejections compared to 5 in 2022. Four medications were rejected in 2020, but no pharmaceuticals were rejected in 2021. In a similar vein, five medications were denied in 2019.

As analyzed by us, the FDA’s approval of antiviral drugs from 2019 to 2023 shows a growing trend in regulatory policy and pharmaceutical innovation. The figures show a significant increase in antiviral drugs that have been licensed, which is indicative of the industry’s emphasis on fighting viral infections-including those linked to pandemics and emerging diseases.²¹

Our analysis also clarifies the causes of drug rejections, highlighting the need to follow FDA guidelines to avert regulatory action. Our findings show that upholding safety and efficacy requirements is essential to the development of new pharmaceuticals. Effective cooperation between pharmaceutical companies and regulatory bodies, like the FDA, is essential to promoting innovation and guaranteeing adherence to changing guidelines. This cooperative approach highlights the value of ongoing research and development in tackling public health issues and advances our knowledge of pharmaceutical development.

I am grateful to Chalapathi Institute of Pharmaceutical Sciences and Mr. Koushik Yetukuri for their unwavering support and guidance in completing this article.