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The FDA's drug approval process may become easier but may result in these side effectsby Alix Hines
Science

WATCH: The FDA's drug approval process may become easier but may result in these side effects

Researchers at the Yale School of Medicine recently published a study that found nearly a third of drugs cleared by the Food and Drug Administration between 2001 and 2010 had safety problems after they became available to patients. 

It also found that it took a median of 4.2 years after approval for the safety issues to become apparent. 

In addition, the study showed that drugs cleared as part of the FDA's accelerated approval process were more likely to be flagged for safety concerns later on. 

Despite all this, there's still a huge push from parts of the U.S. government to speed up the drug approval process. Last year, President Barack Obama signed the 21st Century Cures Act into law. The law is designed to speed up the drug approval process by relaxing certain traditional clinical trial requirements, among other things.

In his first address to a joint session of Congress, President Donald Trump vowed to "slash the restraints" on the FDA's "burdensome" drug approval process. 

21st Century Cures Act

How long does the new drug development process take? 

On average, it takes researchers 12 years to get a drug from the research lab to the patient, according to the California Biomedical Research Association. On top of that, only five in 5,000 drugs that make it to preclinical testing ever make it to human testing, and only one of those five is ever approved for human use. 

The 1992 Prescription Drug User Fee Act established a two-tiered system to review new drugs.

The law created a system called "priority review," which is applied to drugs that "offer major advances in treatment, or provide a treatment where none existed." The FDA has a goal of completing a "priority review" in six months. Drugs that offer only a minor improvement over existing marketed therapies fall under a "standard review" process, which is supposed to be completed in 10 months. 

"At any one time, thousands of new drugs are being researched and developed to treat and cure the diseases [that] affect both humans and animals," according to the association.

How does a drug get approved? 

The company sponsor of the newly developed drug then tests it in a lab and on animals. 

From there an Investigational New Drug Application (IND) is sent to the FDA. The IND must include manufacturing information as well as a plan to test the drug on humans. The FDA reviews the IND and determines whether testing will pose a significant risk of illness or injury. 

Once the drug is cleared, it moves into a three-phase clinical trial. 

During phase one, the drug is distributed to between 20 and 80 healthy volunteers. The process is meant to determine whether the drug is safe. 

Phase two is meant to determine the effectiveness and proper dosage of the drug. In this step, the drug is given to anywhere from 100 to 300 volunteers with the disease or condition. 

In the final phase of clinical trials, physicians monitor patients to determine the effects of the drug and whether it has any side effects. This typically involves 1,000 to 3,000 volunteers with the condition.

Once all three phases of the clinical trials are completed, the pharmaceutical company must file a New Drug Application with the FDA. Then it's up to the FDA to review the data and inspect the facilities where the drugs will be produced to determine whether it is safe and effective. 

So are all those steps totally necessary? 

Well, the Yale study found that drugs that went through an accelerated approval process were more likely to be flagged for safety concerns. 

Other studies have shown that drugs approved using an expedited process often end up needing additional warning labels. So according to the Yale School of Medicine's study, slow and steady in terms of drug approval, could very well be the best approach.