Compliance Update : How does FDA Evaluate The Regulated Drugs ?

The Food and Drug Administration’s Strategic Action Plan for Risk Communication is an initiative to tell consumers how the agency makes decisions on the safety and effectiveness of FDA-regulated products. This is the first in a series of articles about the data and methods—and their limitations—that FDA uses to determine whether products are safe for patients and consumers to use.

This is how the agency’s Center for Drug Evaluation and Research evaluates the safety and effectiveness of drugs.

The Regulation of Drugs
How the Facts Are Collected

• The first step for a company seeking approval to sell a new drug is to perform laboratory and animal tests to learn how the drug works and if it will be safe enough to be tested in humans. The company submits an Investigational New Drug Application (IND) for FDA’s review prior to testing in humans.
• The company performs a series of clinical trials in humans in three phases, which FDA monitors, to test if the drug is effective and safe.
• Next, the company sends its data from all these tests to FDA's Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). A team of CDER physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data and proposed labeling.
• If this review establishes that a drug's benefits outweigh its known risks for its proposed use, the drug is approved for sale.
• After the drug is on the market, the FDA monitors its performance in a number of ways. One of those ways is the through MedWatch, the agency’s safety information and adverse event reporting program, which receives reports of suspected adverse reactions (side effects of medicines) from consumers, health care practitioners and pharmaceutical companies. And the agency has access to databases that collect information on prescription drug use and health outcomes. These data help FDA staff identify and understand side effects of medicines.
• If an unexpected drug-related health risk is detected, a Drug Safety Communication may be issued to consumers and healthcare professionals. A statement is added to the drug label about the new safety concern to ensure continued safe and effective use of the drug. Occasionally, approved drugs may be withdrawn from the market for serious safety risks if it is determined that the overall risks outweigh any benefits the drug may provide.

The Limitations of Safety Data

• FDA provides guidance to companies during the various phases of the human clinical trials. Even so, the number of people in a clinical trial of a new drug is usually small in comparison to the number of people who may take the drug if it reaches the market. This makes it difficult to detect rare side effects.
• Even though data from human trials are analyzed by a team of experts before a drug is approved, it can be impossible to anticipate all bad reactions—especially very rare safety risks—unless they had also happened with use of a similar drug.
• Complicating matters is the fact that after they are approved, drugs are often taken by sick people who are on other medications at the same time, making it difficult to predict how they will react to the drug. And the drug’s effect on the patient may change over the course of years.
• There are hundreds of thousands of adverse events reported via MedWatch each year, but this reporting system is voluntary and there are serious drug reactions that are never reported.
• Because the nation’s healthcare system is not integrated, there is no standard way to track the adverse effects of a medicine in any given health system or across different health systems. Health insurance databases can be helpful in this regard, but they are only accurate as long as a patient has the same job and is enrolled with the same insurance system since many people are insured through their employer. This limits FDA’s ability to monitor the safety of medications taken over many years.  However, FDA, through its Sentinel Initiative, is currently working to develop capabilities to use data from different health systems to better understand the safety of drugs in clinical practice.

Ultimately, FDA faces a balancing act in evaluating a new drug. If it’s good for one person or a small group, will it be good for the whole population?  Which safety risks are likely to be acceptable to patients who might take a drug and physicians who might prescribe it? Once a drug is marketed and new information about its safety becomes available, FDA must revisit these questions continually over the drug’s lifecycle.

In the end, no matter how much data are available, we often have to make a judgment call, weighing the known benefits against known risks and the potential—and possibly unknown—risks.

Source: FDA
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How to withstand an FDA audit of your facilities: A primer for clinical sites, manufacturing facilities and labs

Scheduled On : Monday, February 10, 2014 at 1 PM EST | 10 AM PST

Duration : 60 Minutes

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Description : 

In this webinar, you will learn how convert an FDA audit into an opportunity to demonstrate high quality products and services, and to increase credibility in the industry for your company.

The FDA reserves the right to audit any facility involved in manufacture, testing or development of food and drug products. These include not only drugs and biologics but also medical devices, diagnostic kits, dietary supplements, veterinary products, and animal and clinical testing facilities. FDA audits are an essential part of assuring compliance with the current regulations. Although most FDA audits are preannounced, FDA does conduct unannounced inspections of facilities that it suspects of noncompliance. FDA conducts thousands of audits each year of facilities World-wide to assure that products and services available to the American public are of acceptable quality.

FDA audits are very detailed and systemic reviews of a given facility that could span over several days, involve most personnel working at the facility under review, and if evidence of non-compliance is found, could lead to severe restrictions and/or penalties on the responsible parties. More often than not, facilities and personnel are ill-prepared and unaware of the dos and don’ts for an FDA audit and thus get into trouble for easily avoidable errors. Hence, it is very important that at all times FDA-regulated companies be aware of the regulations, logistics, and practical aspects of an FDA audit to be able to successfully withstand the same.

If your company is marketing a product or service that is regulated by the FDA, you should be prepared for an FDA audit. If you have never been audited by the FDA or if you were last audited 4-6 years ago, if any product or service you offer has been in the news – positive or negative, or if you are getting ready to submit a clinical trial or marketing approval application, chances are you would get audited by the FDA in the near future. Although different facilities are subject to different regulations, FDA auditors follow some general guidelines that are common across all. We will discuss the general rules and specific case studies to highlight the common themes and differences across facilities subject to GCP, GMP or GLP regulations.

Areas Covered in the Session :

This seminar will discuss ways to be prepared for an FDA audit, conduct during an audit, and follow-up activities to an audit. Topics covered include:

• Types of FDA audits
• Key guidelines available from FDA
• GCP/GMP/GLP requirements
• Preparing for the inspection
• Why inspections are conducted and by what statutory authority?
• Reasons for FDA conducting an inspection
• What to expect from an audit?
• What is subject to FDA purview and what's off-limits?
• Preparing for an audit
• What you need to know and do
• Prepare for, during and even after the inspection
• Actions to be taken upon the investigator's arrival
• Logistics of the FDA audit
• Do’s and don’ts of an FDA audit
• Follow-up to an FDA audit
• What to do next?
• How to respond to findings and facilitating the documentation and remediation process
• How to reach Final Closure

Who Will Benefit: 

This webinar will provide valuable assistance to all personnel in: 

• Quality Assurance professionals
• Quality Control professionals
• Regulatory affairs / Compliance professionals
• Senior management executives (CEO, COO, CFO, etc)
• Manufacturing managers, supervisors & personnel 
• Clinical and Preclinical laboratory managers
• Clinical trial specialists
• Project Managers
• People investing in FDA-regulated product development projects

Speaker Profile

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational project management for medicinal and diagnostic products. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.