FDA Approval Process and Criticisms | TorHoerman Law

What Is the FDA Approval Process?

The United States Food and Drug Administration, known as the FDA, reviews and approves new prescription drugs and medical devices before companies can put them on the market. The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for ensuring that drugs sold in the U.S. are both safe and effective.

While the FDA approval process is used to keep consumers safe, the regulatory agency’s methodologies have garnered widespread scrutiny. Many have argued that the agency’s processes are flawed and responsible for keeping lower-cost drugs off of the market. Soaring prices of U.S. healthcare, along with high-profile pharmaceutical lawsuits in recent years, have raised many questions about how the system works and who it benefits the most.

How the FDA Approves New Drugs

Pharmaceutical companies hoping to sell new prescription drugs, vaccines, or other treatments in the United States must gain FDA approval. Companies pursue a five-stage drug development process, and they must present evidence to the CDER from each phase.

1. Discovery and development: Researchers examine data from a variety of sources about diseases, medical procedures, and molecular compounds to find promising opportunities for new drugs.
2. Preclinical research: Before a drug can be tested on humans, researchers conduct extensive lab and animal testing to evaluate its safety and effectiveness. This process can take several years to ensure adequate safety before clinical trials.
3. Clinical research: Potential new drugs are tested in a series of human clinical trials to make sure treatments are not only safe but also effective, and that the benefits outweigh the risks.
4. FDA review: The CDER closely examines evidence that the company presents from every development phase thus far, and makes the decision on whether or not to approve it.
5. FDA post-market safety monitoring: Following approval and distribution to the public, the FDA continues to monitor drugs and devices for safety.

These five phases outline the basic process that most new drugs and devices follow, but there are variations and exceptions based on the type of product and the condition it’s intended to treat.

FDA Accelerated Drug Approval

Companies and consumers have long complained that the FDA approval process is too slow, particularly in the case of potentially life-saving drugs. In response, the agency has implemented certain programs that can speed up the approval of drugs in certain cases. There are four types of expedited approaches that a manufacturer may request if they believe their product fits the criteria:

• Priority Review
• Fast Track
• Breakthrough Therapy
• Accelerated Approval

These four approaches each differ slightly in their qualifications and their advantages for approval, but all are essentially designed to speed up the development of much-needed drugs. An example would be new treatments for serious conditions like cancer or Alzheimer’s. In the case of the COVID-19 pandemic, vaccine applications received priority review due to the urgent need and demand.

Name-brand Drugs

Drugs known by name brands are typically those brought to market as a new drug by a particular company. As a brand new drug, vaccine, or medical device, products are typically subject to extra scrutiny within the five-stage process outlined above.

After conducting sufficient research on the drug’s efficacy and safety, a pharmaceutical company submits a New Drug Application (NDA) to the FDA. The NDA must include extensive data and test results, manufacturing specifications, and the proposed label for the product (including usage instructions, effective dosage, and potential risks).

FDA scientists and researchers then review the company’s submitted labeling, information, and research. This is when the agency determines if the findings prove that the drug meets the safety and quality standards. Note that the agency itself usually does not test drugs before making a decision, it only reviews data provided by the sponsoring company. The FDA may, however,  inspect the manufacturing facilities before approval.

Generic Drugs

The Food and Drug Administration’s process for approving generic drugs is a bit different. Generic drug manufacturers do not need to repeat the same clinical trials conducted for the brand-name drug that they are replicating. The company submits an abbreviated NDA that contains many of the same steps but without as many initial laboratory tests.

Instead, generic drug manufacturers must prove that the drug is essentially the same as the brand-name drug. This includes verifying that the ingredients are as effective in treating the illness or condition as the brand-name drug is and that the generic drug produces the same reaction in the human body. After approval, generic drug manufacturers often still have to find a way around brand-name companies’ patents.

Medical Devices

The FDA medical device approval process follows essentially the same five stages as the drug approval process. In the case of devices, companies submit a pre-market notification to the FDA. The agency then examines the evidence from all prior research and clinical trials, looking for sufficient proof that the device’s benefits outweigh the risks. Even so, faulty devices sometimes make it to market and cause harm to medical patients.

The entire process can take years for potentially risky devices, but as with new drugs, there are ways that companies and the FDA can speed up the approval.

Criticisms of the FDA Approval Process

Even though the process of approving a drug can be lengthy and contain many steps, dangerous products can still slip through the cracks, and untold numbers of people are affected every year. TorHoerman Law keeps a list of current bad drug and medical device lawsuits, but these represent just a fraction of the total claims regarding side effects, personal injury, and wrongful death due to pharmaceutical products — many of which don’t ultimately get very far in the court system.

On top of all this, the United States spends far more on healthcare per person than other high-income nations, meaning Americans pay more for drugs and treatment than most other people in the world. Because of several faults in the FDA approval process, many pharmaceutical products can maintain their high prices — much to the chagrin of most Americans who can’t afford these high prices.

This fact, along with persistent problems like the COVID-19 response and the opioid overdose epidemic, has raised serious criticisms of the FDA process and its outcomes.

Drug Patents

Drug patents can make it difficult for generic drugs to make it to market. While generic-drug companies are allowed to work on drugs for FDA approval before the brand-name patent expires, the brand-name company has the legal advantage and therefore massive control over price in the market.

Generic drug manufacturers are required to notify the patent holder if they are challenging the existing patent; this includes claims that the patent is not valid or the generic drug does not infringe on the brand patent. If courts determine that the generic drug does infringe on a patent, the FDA cannot approve the generic drug for at least 30 months. Current U.S. drug patents are valid for 20 years from the date the application is filed. This makes it difficult for generic drugs to make it to market.

Pay-for-Delay

“Pay-for-delay” agreements are another reason why lower-cost, generic drugs don’t always make it to market. These agreements – also referred to as “reverse payment” agreements or “exclusion payment” agreements – are patent litigation settlements where a brand-name drug company pays the generic manufacturer to drop its patent challenge and keep its lower-cost product out of the market. This lets the brand-name company maintain high prices while potentially monopolizing the market.

Pay-for-delay agreements hurt consumers who lose out on potentially cheaper prescription drug prices. In fact, the Federal Trade Commission  (FTC) estimated that from 2010 to 2020, pay-for-delay agreements cost American consumers $3.5 billion per year. The FTC has filed several antitrust lawsuits against such agreements and has recommended that Congress pass legislation to protect consumers, but no comprehensive law has yet been enacted at the federal level.

Conflicts of Interest

Other widely voiced criticisms of the FDA involve conflicts of interest in the drug approval process and agency committees. Common concerns include:

• A “revolving door” of personnel between government agencies and private industry, leading to FDA officials making decisions that favor companies over the public.
• FDA funding is not entirely from the federal budget but relies on “user fees” from pharmaceutical companies. Critics argue that this model pressures the FDA to pursue financial interests over the public interest.
• The FDA utilizes advisory committees of industry experts, many of whom work in the private sector rather than for the government. This means that committee members retain financial ties to the industry, and in some cases, ties to the very company sponsoring the application in question.

While a certain amount of conflicting interest may be unavoidable to maintain expert oversight, the breadth of these criticisms suggests substantial room for improvement for FDA to prioritize public safety over pharmaceutical industry profits.

Inadequate Monitoring Post-approval

The FDA’s post-approval monitoring of drugs and devices has also been criticized as inadequate. Many people argue that the agency is not doing enough to monitor the safety and effectiveness of drugs once they are on the market, and that this lack of accountability puts the public at risk.

The fact that thousands of drugs and devices are recalled every year in the U.S. suggests serious flaws in the approval system, but surprisingly, the FDA does not have the authority to mandate the recall of drugs in the same way it does vaccines or medical devices. This means that although the FDA can recommend the removal of a drug from the market, the decision to recall is ultimately left up to the manufacturer.

Reporting Drug Injuries and Drug Side Effects

Because pharmaceutical companies hold so much sway, the onus often falls on consumers to hold them accountable in the form of lawsuits. Unfortunately, members of Congress have introduced bills at the federal level designed to strip away consumer rights and further shelter pharmaceutical companies from accountability. If you wish to report a case of drug injury or side effects, expert legal help is crucial for improving your odds against pharmaceutical corporations.

Injured by an FDA Approved Drug or Medical Device?

The FDA drug-approval process is designed to protect consumers from dangerous and adverse side effects. While the agencies’ regulations do increase safety and accountability, millions of Americans are at risk every year of complications, injuries, and even death from bad drugs. TorHoerman Law maintains a detailed list of current bad drug lawsuits. If you suffered any injuries or complications because of a bad drug, contact us today to learn more about your options.