2012 FDA Warning Letters: What Can Be Learned?

November 22, 2012

So far in 2012, the FDA has issued nearly 300 warning letters. More than half of those were sent to companies within the pharmaceutical, medical device and dietary supplement industries

he report states that in the first year of Dr. Margaret Hamburg’s tenure as FDA Commissioner, the number of warning letters increased 42 percent. In her second year, the number of warning letters rose a staggering 156 percent.

Labeling & Misbranding

One major responsibility of FDA is to ensure that the products it is in charge of regulating are correctly labeled and branded. The agency spells out specific labeling guidelines on its website and provides detail to the requirements that businesses must meet in order to be in compliance.

When browsing the various warning letters issued by FDA, a broad spectrum of labeling and misbranding issues are identified. This includes, but is not limited to:

• Failure to bear adequate directions for use on labeling for the purposes for which the product is intended;

• Failure to furnish material or information required by FDA; and

• Failure to provide adequate directions for use on labeling.

Reviewing FDA guidance and regulations affecting the labeling and branding of products will help businesses ensure compliance and ultimately prevent enforcement action from occurring.

Current Good Manufacturing Practice Violations

FDA ensures the quality of drug products, medical devices and dietary supplements by carefully monitoring compliance with Current Good Manufacturing Practice (CGMP) regulations. These regulations contain minimum requirements for the methods, facilities, and controls used in the manufacturing, processing and packing of a regulated product. In short, CGMP rules in essence ensure the safety of a product.

Some of the most common reasons identified for receiving warning letters over CGMP violations include, but are not limited to:

• Failure to establish and maintain adequate procedures for implementing corrective and preventive actions;

• Failure to establish a quality policy and quality objectives; and

• Failure to adequately conduct quality audits.

In many cases, CGMPs are straightforward. But, if such regulations are not implemented in a firm’s Standard Operating Procedure (SOP), they can be easily overlooked. All businesses should regularly review such plans and update them to ensure they are consistent with regulatory expectations.

Misleading Promotional Claims

FDA wants to ensure that a complete picture of each product is adequately conveyed to the public by the companies it regulates and will likely review such marketing materials during an inspection. Product claims made on a company’s website are also up for review by the agency.

Three of the most common reasons identified for receiving warning letters over promotional materials include, but are not limited to:

• False and misleading claims;

• Unapproved use of drugs (i.e., “off-label” claims); and

• Intentions to be used to cure, mitigate, treat, or prevent of disease.

Source: http://www.pharmpro.com/Articles/2012/10/2012-FDA-Warning-Letters–What-Can-Be-Learned/

 


What FDA Regulates

March 24, 2012

FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public. Some of the agency’s specific responsibilities include:

Biologics

  • product and manufacturing establishment licensing
  • safety of the nation’s blood supply
  • research to establish product standards and develop improved testing methods

Cosmetics

  • safety
  • labeling

Drugs

  • product approvals
  • OTC and prescription drug labeling
  • drug manufacturing standards

Foods

  • labeling
  • safety of all food products (except meat and poultry)
  • bottled water

Medical Devices

  • premarket approval of new devices
  • manufacturing and performance standards
  • tracking reports of device malfunctioning and serious adverse reactions

Radiation-Emitting Electronic Products

  • radiation safety performance standards for microwave ovens, television receivers, diagnostic x-ray equipment, cabinet x-ray systems (such as baggage x-rays at airports), laser products, ultrasonic therapy equipment, mercury vapor lamps, and sunlamps
  • accrediting and inspecting mammography facilities

Veterinary Products

  • livestock feeds
  • pet foods
  • veterinary drugs and devices

Source: FDA


Food Safety and Raw Milk

December 9, 2011

Pasteurization of milk was adopted decades ago as a basic public health measure to kill dangerous bacteria and largely eliminate the risk of getting sick from one of the most important staples of the American diet.  In 1987, the agency issued a regulation prohibiting the interstate sale of raw milk.

In recent years, however, a small number of Americans (less than 1 percent) have rejected pasteurization in favor of raw (or unpasteurized) milk, citing a range of taste, nutritional and health benefits they believe are associated with raw milk consumption, as well as a general preference for unprocessed food.  Today, 20 states explicitly prohibit intrastate raw milk sales in some form and 30 allow it.

FDA strongly supports the application of effective measures, such as pasteurization, to protect the safety of the food supply and maintain public confidence in such important, healthy staples of the diet as milk.

Source: FDA

 

 

 


FDA unveils new global strategy to help ensure safety and quality of imported products

June 20, 2011

The U.S. Food and Drug Administration today unveiled a new strategy to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain in a report called the “Pathway to Global Product Safety and Quality.”

“Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D.

The FDA report calls for the agency to transform the way it conducts business and to act globally in order to promote and protect the health of U.S. consumers. Highlights of the report include four key elements needed to make the change:

1. The FDA will partner with its counterparts worldwide to create global coalitions of regulators focused on ensuring and improving global product safety and quality.

2. The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.

3.  The FDA will build in additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology.

4. The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

“FDA regulated imports have quadrupled since 2000,” Hamburg said. “The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face.  The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission.”

Click here to read more

Source : FDA

 


About Food Safety Modernization Act (FSMA)

May 20, 2011

The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4th, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it.

Background

About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention.  This is a significant public health burden that is largely preventable.

The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur.

The law also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur.  The law also gives FDA important new tools to hold imported foods to the same standards as domestic foods and directs FDA to build an integrated national food safety system in partnership with state and local authorities.

Source: FDA


Comment on Proposed Regulations and Submit Petitions: FDA

March 8, 2011

As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation-emitting electronic products, and medical devices–commodities close to the daily lives of all Americans.

By law, anyone can participate in the rule-making process by commenting in writing on rules FDA proposes. FDA routinely allows plenty of time for public input and carefully considers these comments when it draws up a final rule.

FDA gathers public comments mainly through 2 channels: proposed rules and petitions.

Proposed Rules

When FDA plans to issue a new regulation or revise an existing one, it places an announcement in the Federal Register on the day the public comment period begins. Published every weekday, the Federal Register is available at many public libraries and colleges, and on the FDA Web site. Issues open to public comment often are reported by the news media and can also be found at regulations.gov. Instructions for finding Federal Register documents and submitting comments are found on  the Federal Dockets Management System Instruction Sheet.

Also noted is the “comment period,” which specifies how long the agency will accept public comments. Usually, the file–or docket–stays open for comments at least 60 days, though some comment periods have been as short as 10 days or as long as nine months. Weekends and holidays are included in the comment period.

Comment Online

The Federal Dockets Management System Instruction Sheet tells how to submit comments electronically at regulations.gov.

Petitions

Another way to influence the way FDA does business is to petition the agency to issue, change or cancel a regulation, or to take other action. The agency receives about 200 petitions yearly.

Petitions require careful preparation by the submitter. FDA spends considerable time and staff resources processing petitions. Individuals sometimes submit petitions, but most come from regulated industry or consumer groups.

Source: http://www.fda.gov/RegulatoryInformation/Dockets/Comments/default.htm


FDA: Compliance & Enforcement

September 21, 2010

Please find here  links to information about clinical investigators who have and/or are participating in clinical trials of pharmaceutical products as well as regulatory correspondence and restrictions resulting from noncompliance observed during bioresearch monitoring (BIMO) inspections.

Regulatory Activities

Clinical Investigator List

The Clinical Investigator Inspection List, maintained by the Center for Biologics and Evaluation Research, contains names, addresses, and other information gathered from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER. These inspections were conducted as part of the Food and Drug Administration’s Bioresearch Monitoring Program. This list contains information on inspections that were closed after 1989.

Click here to check the details: Clinical Investigator List (PDF – 3.13 MB)

Bioresearch Monitoring Information System File (BMIS)

BMIS contains information submitted to FDA identifying clinical investigators (CIs), contract research organizations (CROs), and institutional review boards (IRBs) involved in the conduct of Investigational New Drug (IND) studies with human investigational drugs.

The information has been abstracted from FDA Forms 1571 and 1572 and other pertinent documents contained in IND submissions (e.g., C.V.s, cover letters, investigator lists, etc.). Please note that this file contains a separate entry for each time an investigator, CRO or IRB is identified in a new submission. For example, if an investigator is named in 10 INDs, his/her name will appear 10 times in this file.

Click here to check the details: Bioresearch Monitoring Information System File (BMIS)

Investigational Human Drugs Clinical Investigator Inspection List

The Clinical Inspection List, maintained by the Center for Drug Evaluation and Research, contains the names, addresses and other information obtained during FDA inspections of clinical investigators who have performed studies with human investigational drugs. The list contains information on investigators inspected since July 1977 whose files have been closed with a final classification.

Click here to check the details: Investigational Human Drugs Clinical Investigator Inspection List

Warning Letters

A Warning Letter is an informal advisory to a firm communicating the Agency’s position on a matter but does not commit FDA to taking enforcement action. The Agency’s policy is that a Warning Letter should be issued for violations which are of regulatory significance in that failure to adequately and promptly take corrections may be expected to result in enforcement action should the violation(s) continue.

Click here to check the details: Warning Letters

Source: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ComplianceEnforcement/default.htm