Sunday 10 July 2016

FDA Drug Regulation Procedure

The Food and Drug Administration (FDA) has the highest responsibility of regulating the safety of drugs and other medicines sold in the U.S. The approval process is divided into a pre and post phase and drugs cannot be sold on the market without FDA approval.

By Michael Monheit

How Information About Drugs Is Collected By The FDA

The FDA collects facts regarding new drugs entering the U.S. market by following these basic guidelines:

Perform Tests

When a company seeks approval for selling a drug on the U.S. market, it must first perform a drug test on animals in a laboratory to establish how the drug works in humans. Once these tests are complete, the company must present an Investigational New Drug Application (IND) and must get FDA approval before it can test the drug on humans.

Clinical Trials

The company will then undertake a three-phased human clinical trial process, which is monitored closely by the FDA. This is undertaken to ensure that the drug is safe and effective for the general public.

Data Sent To FDA Regulatory Body For Review

Once the data has been collected from the clinical trials, the company sends this information from all the tests as a New Drug Application (NDA) to the Center for Drug Evaluation and Research (CDER) of the FDA. The CDER statisticians, pharmacologists, toxicologists and physicians study and review the information given by the company. If this review determines that the benefits are more valuable than the potential risks during use, the FDA approves the drug for selling on the market.

After-Market Performance And FDA Monitoring

After the drug hits the market, the FDA monitors its performance in a myriad of ways. Medwatch, the safety information, and reporting program generally receives reports about any side effects or adverse reactions to any drugs from health care practitioners, pharma companies, and consumers. Medwatch also accesses databases that gather information about health results and use of prescription drugs. This data enables FDA staff to understand and identify medicinal side effects.

If the drug presents unexpected risks, then consumers and healthcare practitioners are issued with Drug Safety Communication from the FDA. A new drug label is introduced with a safety concern statement to ensure that the drug is used in a safe and effective manner. For instance, Xarelto, a blood thinning medication was prescribed to millions of patients across the country to prevent stroke-causing blood clots. While there hasn't been a recall of the drug, the FDA has issued a series of safety communications about the drug, along with two black box warnings. has stated that this black box type of warning is the strictest form of warning that the FDA can issue for any drug. This warning comes because there is reasonable evidence of major side effects associated with Xarelto.

In some instances, drugs with major adverse effects will be withdrawn from being sold on the market because of the safety hazards they pose. This is because the FDA determines that the risks of that particular drug outweigh the benefits it provides. In December 2014, the FDA delivered an Adverse Reaction report about Xarelto resulting in low blood platelet counts or thrombocytopenia. Before this, the FDA issued several warnings about Xarelto to the public. The FDA cautions patients taking certain medications to discontinue the use of Xarelto, as a way to responsibly communicate with them.

Limitations Associated With Garnering Safety Data

While the FDA makes a strong effort to properly regulate drugs, some limitations are associated with safety data:

The FDA offers guidance during clinical trials, but the number of people is small in comparison to when the drug reaches the market. This makes it hard to determine side effects initially.
Even though experts review clinical trial data, it is hard to detect all possible side effects from the drug.
When people on other drugs take a certain drug, it is practically impossible to ascertain the kind of reactions the combination creates.

At the end, the FDA faces several challenges when evaluating new drugs. A particular drug will be effective for some people while it may produce side effects in others. Once a drug is on the market, the FDA must continuously review it during its lifecycle to ensure safety for patients.


Michael Monheit, the managing attorney at Monheit Law, has been working to assist individuals and families who have been harmed by defective drugs and products. In fact, Mr. Monheit served on the Plaintiff’s Steering and Executive Committee for MDL 1148. He understands how stressful it can be to stand up to a major corporation and is committed to making sure that plaintiffs know they have someone on their side.

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