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/

 


WHO Good Manufacturing Practices: water for pharmaceutical use

April 6, 2012

The guidance contained in this document is intended to provide information about the available specifications for water for pharmaceutical use (WPU), guidance about which quality of water to use for specific applications, such as the manufacture of active pharmaceutical ingredients (APIs) and dosage forms, and to provide guidance on the good m anufacturing practice (GMP) regarding the design, installation and
operation of pharmaceutical water systems.

Water is the most widely used substance, raw material or starting material in the production, processing and formulation of pharmaceutical
products. It has unique chemical properties due to its polarity and hydrogen bonds. This means it is able to dissolve, absorb, adsorb
or suspend many different compounds. These include contaminants that may represent hazards in themselves or that may be able to react
with intended product substances, resulting in hazards to health.

Different grades of water quality are required depending on the route of administration of the pharmaceutical products. One source of guidance about different grades of water is the European Medicines Evaluation Agency (EMEA) Note for guidance on quality of water for pharmaceutical use (CPMP/QWP/158/01).

Control of the quality of water throughout the production, storage and distribution processes, including microbiological and chemical quality, is a major concern.

Source: http://apps.who.int/prequal/info_general/documents/TRS929/WHO_TRS_929-Annex3.pdf


Guidance for Preparing Standard Operating Procedures (SOPs)

April 5, 2012

The U.S. Environmental Protection (EPA) Agency has developed an Agency-wide program of quality assurance for environmental data. EPA’s Quality System requires documentation of both management and technical activities. This guidance document, Guidance for Preparing Standard Operating Procedures (SOPs) provides a standard working tool that can be used to document routine quality system management and technical activities. It replaces EPA’s March 2001’s Guidance for Preparing Standard Operating Procedures (SOPs) EPA/240/B-01-004 with minimal revisions in text and new examples of both technical and administrative SOPs.

A Standard Operating Procedure (SOP) is a set of written instructions that document a routine or repetitive activity followed by an organization. The development and use of SOPs are an integral part of a successful quality system as it provides individuals with the information to perform a job properly, and facilitates consistency in the quality and integrity of a product or end-result. The term “SOP” may not always be appropriate and terms such as protocols, instructions, worksheets, and laboratory operating procedures may also be used. For this document “SOP” will be used.

Source: http://www.epa.gov/quality/qs-docs/g6-final.pdf


How to Report a Problem (Medical Devices)

March 30, 2012

What is Medical Device Reporting (MDR)?

Medical Device Reporting (MDR) is the mechanism for the Food and Drug Administration to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. If you are a consumer or health professional you should use the nearby link to the MedWatch program for reporting significant adverse events or product problems with medical products.

User Facilities and MDR

User Facilities (e.g., hospitals, nursing homes) are required to report suspected medical device related deaths to both the FDA and the manufacturers. User facilities report medical device related serious injuries only to the manufacturer. If the medical device manufacturer is unknown, the serious injury is reported by the facility to FDA. Health professionals within a user-facility should familiarize themselves with their institution procedures for reporting adverse events to the FDA.

There is a guidance for user facilities, “Medical Device Reporting for User Facilities”.  See its nearby link.

Note: Please do not send the actual device to FDA as stated in Block D9 of the MEDWATCH 3500A form. In Block D9 indicate that you are keeping the device or returning it to the manufacturer.

History of MDR Regulation

Legislation requiring device user facility reporting was enacted by Congress to increase the amount of information the Food and Drug Administration (FDA) and device manufacturers receive about problems with medical devices. Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports have shown there is widespread underreporting. A 1986 General Accounting Office (GAO) study showed that less than one percent of device problems occurring in hospitals are reported to FDA, and the more serious the problem with a device, the less likely it was to be reported. A GAO followup study in 1989 concluded that despite full implementation of the Medical Device Reporting (MDR) regulation, serious shortcomings still existed.

Under the Safe Medical Devices Act of 1990 (SMDA), device user facilities must report device-related deaths to the FDA and the manufacturer, if known. Device user facilities must also report device-related serious injuries to the manufacturer, or to the FDA if the manufacturer is not known. In addition, SMDA also required that device user facilities submit to FDA, on a semiannual basis, a summary of all reports submitted during that time period. The device user facility reporting section of SMDA became effective on November 28, 1991.

To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, and invited comments on the regulation. Over 300 comments were received by FDA. Then, on June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of the Food, Drug, and Cosmetic Act) relating to reporting of adverse events. The primary impact of the 1992 Amendments on device user facility reporting was to clarify certain terms and to establish a single reporting standard for device user facilities, manufacturers, importers, and distributors. A final rule published in the Federal Register on December 11, 1995, addresses the comments received by the FDA and the changes mandated by the Amendments of 1992.

Reference: http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm

 


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


U.S. Department of Transportation Proposes ‘Distraction’ Guidelines for Automakers

February 29, 2012

Proposed recommendations would encourage manufacturers to develop ‘less distracting’ in-vehicle electronic devices

The proposed voluntary guidelines would apply to communications, entertainment, information gathering and navigation devices or functions that are not required to safely operate the vehicle.

The announcement of the guidelines comes just days after President Obama’s FY 2013 budget request, which includes $330 million over six years for distracted driving programs that increase awareness of the issue and encourage stakeholders to take action.

The proposed Phase I distraction guidelines include recommendations to:

  • Reduce complexity and task length required by the device;
  • Limit device operation to one hand only (leaving the other hand to remain on the steering wheel to control the vehicle);
  • Limit individual off-road glances required for device operation to no more than two seconds in duration;
  • Limit unnecessary visual information in the driver’s field of view;
  • Limit the amount of manual inputs required for device operation.

The proposed guidelines would also recommend the disabling of the following operations by in-vehicle electronic devices while driving, unless the devices are intended for use by passengers and cannot reasonably be accessed or seen by the driver, or unless the vehicle is stopped and the transmission shift lever is in park.

  • Visual-manual text messaging;
  • Visual-manual internet browsing;
  • Visual-manual social media browsing;
  • Visual-manual navigation system destination entry by address;
  • Visual-manual 10-digit phone dialing;
  • Displaying to the driver more than 30 characters of text unrelated to the driving task.

 

Reference: -http://www.nhtsa.gov/About+NHTSA/Press+Releases/2012/U.S.+Department+of+Transportation+Proposes+%27Distraction%27+Guidelines+for+Automakers

 


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