The United States Food and Drug Administration has been around for more than a century. The agency has taken on various roles over the years, acting to ensure that food and medical devices are safe for consumers.
In a way, the agency acts as a consumer protection watchdog, with the ability to keep products from coming onto the market and take enforcement actions against people and companies that violate its rules.
The Pure Food and Drugs Act of 1906
In order to understand how and why the FDA was created, it is necessary to understand the conditions at the time. The turn of the 20th century was the heyday of muckraking journalism and exposes of large corporations. Not that food manufacturers were innocent of wrongdoing.
In 1906, Upton Sinclair’s The Jungle shed light on the despicable conditions at slaughterhouses, revolting and angering the general public who got an inside look at the filth and danger to well-being from these large meat plants.
The lack of federal regulatory powers became an issue as more people moved into large cities and began to use prepackaged foods. Food safety was becoming a major issue, especially as refrigerators were not yet in large use.
The original law was called the Wiley Act, named for one of the chief proponents who advocate forcefully for its passage. Harvey Wiley was a chemist who was the first administrator of the agency.
As a result, Congress passed the Pure Food and Drug Act, which President Theodore Roosevelt signed into law. This version of the food and drugs act placed the federal government more closely into the regulation of food products and cosmetics.
The Prohibition of False Therapeutic Claims
One of the major early challenges to the Food and Drug Administration invoked one of the main purposes of the new regulatory authority.
In a 1912 case, the Supreme Court found that the FDA did not actually have the authority to prohibit false therapeutic claims made by manufacturers.
This was a key moment in FDA history because Congress passed a new law called the Shirley Amendment that specifically prohibited false claims and gave the FDA the authority to take action.
The FDA Begins to Deal with Drug Safety
Even though food and drug safety was addressed in the 1906 law, there were still major gaps in the FDA’s regulatory authority. This was revealed by a mass casualty incident in 1937.
A company named S.E. Massengil began to sell a new drug called Elixir sulfanilamide. This drug was a sulfonamide antibiotic that was improperly prepared. The mistakes caused a mass poisoning event where over 100 people died. The chief chemist committed suicide while awaiting trial.
The resulting outcry prompted Congress to do more in order to prevent mass tragedies such as this one in the future. It was apparent that the FDA needed new rules to regulate foods and drugs.
The Federal Food, Drug, and Cosmetic Act of 1938
The Congressional response to the elixir sulfanilamide incident was to pass new legislation that greatly expanded the FDA’s authority. Congress often reacts in the face of widespread disasters that show the limits of previous regulations.
The FDA of the early years was dramatically transformed, as there were now many more requirements for the pharmaceutical industry to follow. The FDA had greatly expanded oversight of drug manufacturers.
Specifically, the new law did the following:
- Brought cosmetics and therapeutic devices under FDA regulation
- Authorized factory inspections of food and drug makers
- Began the system of drug regulation by requiring that drug safety be proven before the product was allowed to be marketed and sold to the general public – manufacturers must file a drug application before they can sell the product. FDA review is a key part of the FDA process
- Set tolerance levels for unavoidable toxic substances in medicine
- Allowed for criminal prosecution of manufacturers at fault for events like the Elixir sulfanilamide poisoning
- Gave the agency stricter control over clinical trials and new drug trials
It was the 1938 law that launched the FDA as we know it. There have been numerous expansions of the FDA’s authority described below, but the Federal Food, Drug, and Cosmetic Act of 1938 is what gave the FDA much of its authority over consumer products and made it the federal agency that we know today.
Post 1938 Amendments to the Federal Food, Drug, and Cosmetic Act
Over time, Congress enacted additional amendments to the FDA’s authority, expanding the agency’s ability to act.
Here are some of the changes to the agency’s regulatory authority:
- In 1941, Congress passed the Insulin Act, which allowed the FDA to test and certify the purity and efficacy of this drug for diabetes.
- In 1951, Congress passed the Durham-Humphrey amendment which defines the types of medications that cannot be safely used without medical supervision and requires that certain drugs be made available by prescription only.
- In 1962, Congress passed the Kefauver-Harris Amendments, which states that pharmaceutical companies are required to prove to the FDA the effectiveness of new drugs before advertising them.
In 1997, Congress passed a major overhaul to the FDA Act to account for the modernization of food and drug regulation. For example, the overhaul allowed drug manufacturers to research off-label uses of their drugs. Regulation has gotten more nuanced as technology has advanced, and the new laws were supposed to account for it.
The FDA Approval Process for Medications and Medical Devices
Besides food safety, one of the most important functions that the FDA performs in regulating drugs. The agency is supposed to protect the lives and well-being of patients and those who take medications.
The FDA has numerous authorities and processes under which it can review and approve medications and medical devices.
- The FDA can fast-track approval when the drug is a breakthrough therapy or a life-saving treatment
- The main body that reviews drug applications is the Center for Drug Evaluation and Research. Drug manufacturers will test their own drugs and send the results to the CDER, which then reviews the test results. The FDA does not test drugs itself, but rather it reviews the information submitted as part of the application. If an unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The FDA may request more information or require that the manufacturer conduct ongoing testing after the drug is approved.
- Manufacturers that make medical devices that are substantially similar to others that have been approved can take advantage of a special approval process called the 510(k) process. They can begin selling their product 90 days after they notify the FDA, assuming the agency agrees that it is substantially similar to an existing product.
The original maker of the drug is allowed to patent medicines when certain statutory requirements are met.
The exclusive patent period is supposed to incentivize drug companies to invest in research and development. After the patent expires, generic manufacturers can make their versions of the drug.
The FDA will still vigorously regulate generic drugs and will do so after the period of exclusivity has expired.
Common FDA Actions Today
Here are some of the actions that the FDA takes today as part of its regulatory and enforcement authority:
- Ordering adulterated and misbranded food to be removed from the market
- Regulating drug advertising, prohibiting false claims, and requiring disclosure of side effects
- Regulating tobacco products and making rules to restrict access to those underage.
The FDA Is Not an Independent Agency
The FDA is a subagency of the Department of Health and Human Services. As such, the FDA is not an independent agency, and it may be subject to some political pressures because the HHS secretary is appointed by the president and confirmed by Congress.
Given the importance of the function that the FDA performs, some have called for the agency to become an independent one, much in the same way as the Securities and Exchange Commission.
This would free the agency from political pressure and allow it to be more insulated from blowback when it takes difficult steps to protect consumers and patients from potential harm.
Food and Drug Regulation Is Always Evolving
The FDA always faces challenges in regulating food and drugs at the federal level. Business and technology is always changing, and the agency is not always able to keep up with improvements given its existing regulatory tools.
Even when the FDA has regulatory authority, it does not always have an adequate budget to conduct inspections and enforce its rules. There are many instances in which the FDA approves a drug that later turns out to be dangerous.
For example, the FDA fell behind the curve on Zantac, only ordering the drug to be pulled from the market after an independent testing laboratory revealed an inherent danger in the design of the product that led to an increased risk of cancer.
Lawsuits Against Drug Companies and Food Companies
If you or a loved one have been injured by food, drug, or medical device, you may be eligible for financial compensation from the manufacturer.
There are some complicated legal issues involved in drugs and medical devices approved by the FDA, and an experienced attorney can help you navigate these matters as you seek compensation.
The attorneys at Rosenfeld Injury Lawyers fight for you no matter how large of a company you are up against. To schedule your free initial consultation, you can call us at (888) 424-5757 or message us online.