2012 FDA Warning Letters: What Can Be Learned?

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/