The federal government has extensive powers to appoint. These powers are granted by the constitution and play a great role in various regulations. This allows it to appoint federal workers in various agencies such as the FDA. The Food and Drugs Administration (FDA) is one of the agencies under the US Department of Health and Human Services. As a federal agency, it has the power to protect the public by ensuring that “human and veterinary drugs, biological products, medical devices … cosmetics”, the food supply chain, and products with electromagnetic emitters are safe for use.1
FDA and the US Economy
The FDA agency has a wide regulatory jurisdiction to control and supervise a majority of products in the country. The following categories of products fall under the mandate of the agency: foods, drugs, medical devices, biologics, electronic products that emit radiation waves, cosmetics, veterinary products, and tobacco products.2 All these categories cover different industries in the US economy. Foods include all bottled water, supplements, food additives, and other foods; drugs include subscription and non-subscription medicines; biologics features vaccines, tissue and blood products, therapy and allergenic products. Medical devices feature surgical and dental equipment, implants, and other medical technologies; electronics comprise of mercury lamps, laser and x-ray equipment, microwave ovens, and ultrasonic implements; veterinary products encompass animal feeds, supplements and devices, pet food, and drugs. Finally, cosmetic products controlled by the FDA include skin products, color additives in makeup, perfumes and nail polish; tobacco products feature cigarettes and all tobacco.
The wide jurisdiction of the FDA makes it highly involved in all facets of the US economy. By its own admission, the agency is responsible for monitoring products that are worth an upwards of $2.4 trillion.3 Due to its broad mandate to regulate thousands of substances and parts that go into the majority of consumer goods, various industries are dependent on the agency for approval of components and ingredients to make products. This influence goes as far as having an impact on the stock markets, where FDA approvals or restrictions of key product ingredients or components affect stock prices. It can also issue product recalls due to undisclosed ingredients and effects of products or contamination leading to losses for the producers and investors. The agency also routinely inspects production facilities of the products it regulates. This is a critical function for animal and human food, drugs, vaccines, animal farms, and blood banks. Additionally, organizations that run clinical trials on people as well as those that test animals are closely inspected.
The FDA is critical in controlling the pace of innovation in the US economy. Any new product has to pass rigorous tests before it is introduced to the market. Such products often cost a lot in terms of research and development and failure to pass FDA tests affects many investors in such products. The agency also affects the balance of trade of the US as it controls the types of products that can be imported into the market.
Steps to Getting a Drug Approved in the US
Before a new drug can be introduced into the market, the producer must demonstrate that it meets the basic standards of safety and effectiveness.4 This is often known as the FDA Drug Approval Process and is undertaken by the agency’s Center for Drug Evaluation and Research (CDER). The company or drug producer wishing to get approval must first present complete documentation of extensive research and testing that it has already conducted on the drug. The body then goes through these results with the help of its own doctors, chemists, pharmacologists, and other medical professionals to confirm their veracity. This team often undertakes three critical processes that the drug has to pass. The first is an analysis of the target disease conditions and other medications for those conditions. The illness that the drug is intended for is closely evaluated against all other available drugs in the market that treat the illness. This helps the agency develop a scale against which it will measure the risks and benefits that the new drug will bring. This process is often easier for drugs that treat conditions for which no other medications are available, so long as the side effects are not so detrimental to patients, for example, chemotherapy for cancer treatment.
The second step is the evaluation of risks and advantages of the drug using clinical data. The team of FDA medical experts first assess the completeness of the information submitted by the maker of the drug to find any errors, imperfections, or uncertainties present in the clinical data. Usually, the agency requires data from at least two completed clinical trials to remove any doubt that earlier results are not a chance, and to ensure there are no biases.5 For extremely rare diseases and conditions, one well-conducted trial is often sufficient. The results of this step should show that benefits outweigh risks.
The final step is the management of risks. All drugs present a number of risks to patients. The agency works with the manufacturer to develop an appropriate risk management strategy for users, and this is then indicated on the final drug label. Once all these steps are satisfactory to the FDA, the drug goes to market under the FDA post-market safety monitoring. This ensures any risks not caught by the maker or FDA is addressed before mass production and distribution.