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The United States has created comprehensive procedures that manufacturers must follow in order to be able to market a medical device or pharmaceutical drug to the public. These products must be extensively tested internally before being submitted for governmental approval. Even when a company deems a product ready to go to market, the government may review the testing and deny approval based on any number of reasons. If a drug is approved, it must meet standards related to packaging, labeling, and more. Governmental oversight continues once the drug hits the market to monitor the effects of the product on a wider population group. One important tool of this monitoring effort is a reporting system, which allows patients and health care providers the ability to report the adverse reactions that they experience or witness directly to the FDA.
FDA Approval of Pharmaceutical Drugs
The FDA must approve any pharmaceutical drug (including generic and name-brand drugs) for sale in the United States. Before a pharmaceutical company may apply to the FDA, it must conduct pre-clinical testing and clinical trials. If the drug is deemed safe for use after this type of testing, it will proceed for review. A pharmaceutical company must document and submit adverse reactions which occur during testing.
The Center for Drug Evaluation and Research (CDER) is an organization under the FDA that regulates over-the-counter and prescription drugs. A CDER review team consisting of doctors, chemists, pharmacologists, and other scientists will review all findings related to a proposed drug. They may request additional information, if necessary. They will then determine whether or not the drug will be approved. If the drug is approved, the FDA will work with the applicant pharmaceutical company to develop appropriate prescribing information.
If a drug is approved and goes on the market, the FDA will remain involved in monitoring that drug for the entire market lifecycle. This is called “Post-Market Safety Monitoring”.
FDA Adverse Event Reporting System (FAERS)
One tool used in monitoring pharmaceutical drugs is the FDA’s Adverse Reporting System (FAERS). FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events.
Who Can Report to FAERS?
Any interested parties who may have concerns about a pharmaceutical drug may submit a report to FAERS. This includes healthcare providers who prescribe the drug, such as physicians or nurse practitioners, those who distribute the drug such as pharmacists or pharmacy staff, and providers who may witness effects of the drug on patients, such as nurses, medical assistants, and more. Patients themselves are also able to submit reports. Also, other individuals who may have a concern (such as family members, caregivers, and attorneys) may submit a report.
Additionally, manufacturers can report adverse reactions, and, in many cases, are required to report such reactions.
Process for Submitting Reports
Reports may be submitted using the MedWatch Voluntary Reporting Form. Health care providers will submit FDA Form 3500. Consumers will submit FDA Form 3500B. Both of these forms are standardized questionnaires that permit the submitter to include data about the drug/device and side effects experienced or witnessed.
The FDA will accept MedWatch forms for adverse events that have been observed, suspected, or experienced for human medical products, including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures for:
- Prescription or over-the-counter medicines, as well as medicines administered to hospital patients or at outpatient infusion centers
- Biologics (including blood components, blood and plasma derivatives, allergenic, blood transfusions, gene therapies, and human cells and tissue transplants. For example, tendons, bone, and corneas)
- Medical devices (including diabetes glucose-test kit, hearing aids, breast pumps, and many more products)
The FDA will not accept MedWatch forms for vaccines or investigational (study) drugs, as these have separate reporting protocols.
Once a report is submitted, it will be reviewed by the FDA. If necessary, the organization may reach out to the individual who submitted to the report to request further information.
FAERS Public Dashboard
FAERS maintains a dashboard that is accessible to the public. This dashboard may be used to report a problem (the user will be redirected to the MedWatch forms described above) as well as to conduct research of existing reports.
The dashboard also gives snapshot data regarding all reports in the system. The homepage includes a figure for Total Reports, Serious Reports (excluding death), Death Reports. The user can also view cumulative totals of reports in the current year and in proceeding years.
Reports that have been voluntarily submitted directly to the FDA through the MedWatch program by consumers and healthcare professionals are classified as “Direct Reports.” Mandatory reports submitted by manufacturers are categorized as Expedited (reports that contain at least one adverse event that is not currently described in the product labeling and for which the patient outcome is serious) or Non-Expedited (reports that do not meet the criteria for expedited reports, including cases that are reported as Serious and expected, Non-serious and unexpected, and Non-serious and expected).
The dashboard includes tools that allow a user to search for reports based on drug, reaction, report type, region and more.
Current FAERS Data
The database current contains millions of reports. The cumulative total as of July 2019 was more than 17,350,000 total reports. Of this total, around 57% of these reports (9,824,459) were deemed “Serious (Excluding death),” while 1,737,558 were reports of death. In 2017, a total of 1,815,483 reports had been submitted. In 2018, the total number of reports was 2,156,028.
FDA Action on FAERS Reports
The FDA uses FAERS to look for new safety concerns that might be related to a marketed drug or device, evaluate a manufacturer’s compliance to reporting regulations and responding to outside requests for information. The reports in FAERS are evaluated by clinical reviewers in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
If a potential safety concern is identified in FAERS, further evaluation will be performed. This may include conducting studies using other databases. Based on the outcome of this evaluation, FDA may take regulatory actions to improve product safety and protect the public health, such as updating a product’s labeling information, restricting the use of the drug, or communicating new safety information to the public.
FDA Defective Drugs and Devices Recalls
In the event that the regulatory actions listed above are not satisfactory due to the severity of the problem which has been identified, the FDA can issue a recall of a drug or device. This is the most drastic action which the organization may take in response to reports of adverse reactions.
There are three classifications of recalls. A Class I Recall is the most severe. This involves a dangerous or defective drug or device that has the potential to cause serious health problems or death. A Class III Recall is the least severe. In this type of recall, a product is unlikely to cause any adverse health reactions, but there has been found to be some manner of FDA violation in the way that the product has been labeled or manufactured. A Class II Recall targets drugs and devices that might cause a temporary health problem or pose a slight threat of a serious nature.
All classes of recalls are available to the public in the FDA’s weekly enforcement report. This report includes all recalls which have been classified under the above criteria as well as those which have yet to receive classification.
After issuing a recall, the FDA evaluates the response. It will examine the manufacturer’s notifications to consumers and attempts to remove the defective drug or device from the market. If the FDA determines that the recall is not effective, it may request that the company take additional actions.
Defective Pharmaceutical Drug / Medical Device Representation
While these systems are in place in order to make sure that the drugs and devices we use are safe, the reality is that these “adverse reactions” can often be life-altering injuries, illnesses, or even losses of life. Even if the FDA takes action on a defective pharmaceutical or medical device, harm will already have been done to the patients unlucky enough to have been treated prior to corrective action. If you or a loved one suspect that you may have suffered an adverse reaction due to a defective drug or device, contact our legal team. Our extensive experience and resources allow us to take on complex cases with potentially powerful defendants in order to fight for compensation for victims and their families.