FDA issues guidance as start date of new labelling law looms
years will come into effect as of June 30 and the Food and Drug
Administration (FDA) has released a draft technical document to
help drug manufacturers incorporate the changes.
The new drug labelling requirements will be phased in gradually over seven years and will initially apply to newly approved prescription drugs and those approved within the last five years, including drugs that receive approval for new uses.
The technical >document, issued by the FDA's Center for Drug Evaluation and Research (CDER), gives advise on how to use structured product labeling (SPL) Release 2, which was issued in January this year, outlining the required changes for the content and format of drug and biological product labelling.
The most significant format change is a new half-page section called Highlights, which will provide immediate access to the most important prescribing information about benefits and risks and include Boxed Warning, Indications and Usage, and Dosage and Administration sections.
In this part of the SPL, pharmaceutical manufacturers will be required to use the "Problem List" subset of the Systematized Nomenclature of Medicine (SNOMED) to code important terms, said the draft technical document.
The highlights of SPL are supposed to come from three sources: boilerplate text rendered directly from the stylesheet (e.g., "Highlights of Prescribing Information"); data elements inserted into the boilerplate text (e.g., year of initial U.S. approval); and text blocks corresponding to each major part of the highlights.
Other new features include a Table of Contents; the date of initial product approval and contact information for reporting suspected adverse drug events.
Drug makers will now also be required to update the package insert each year and include a list of all substantive changes made within the year.
The new labelling laws are designed to force drug makers to draw the doctor's attention to the most important pieces of drug information before a product is prescribed.
According to the FDA, the changes will make package inserts more user-friendly and simplify the prescribing process, decrease medication errors and improve patient safety.
Over the past ten years, the prescribing information for newly approved products has become more complex, and specific information is often difficult to locate in the package insert.
In US hospitals, 300,000 preventable adverse drug events occur every year, many as a result of confusing medical information.
However, critics in the industry claim the new system will simply make it extremely difficult for anyone to bring legal action against a drug manufacturer for harm caused by one of its products due to a clause slipped in at the eleventh hour.
A recent article in the New England Journal of Medicine describes the clause as "a regulatory time bomb".
