Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

US Regulation of Promotional Materials for Prescription Drugs: a Regulatory Perspective ***

Dr. Annika Wedeking (Abschlußjahr: 2018)

Summary
Language: English
Promotion for approved prescription drug products directed to the health care professional is a usual way to communicate information about a product. In contrast to this, promotion directed to the consumer is permitted in only a very few countries. Among these countries is the US that implemented very strict rules for both audiences overseen by the FDA to regulate this field.
The FDA was incepted by the FD&C Act giving it a broad mandate over information that is disseminated together with, or about a prescription drug. The term "labeling" as defined in this law includes not only the FDA-required labeling, that was reviewed and approved by FDA (e.g. the full prescribing information), but also labeling that accompanies an article. From a regulatory perspective only the textual relationship between the drug and the item is important. As a result, FDA not only regulates prescription drug product advertisement but also promotional labeling.
Even though promotional material also has a commercial motivation, it provides essential information to consumer and health care professionals enabling them to decide about the use of a drug. To ensure that risk and benefits are communicated in a balanced, non-misleading and truthful manner several rules set up by FDA must be followed. Promotional materials must only include product claims consistent with the FDA approved label supported by an appropriate level of evidence, and presented in a balanced way together with safety risk statements. Most promotional materials are also required to include a brief summary, including for example side effects and contraindications, or, applicable for certain promotional labeling materials, the products prescribing information.
The FD&C Act also provides the FDA with the authority to take administrative and jurisdictional actions against a sponsor who released material, which is not according to the “general rules” but misleading instead. Promotional activities are closely monitored by the Office of Prescription Drug Promotion (OPOD). In its duty to police that information, contained in promotional material, is not false or misleading the Office can initiate enforcement actions or issue a Warning letter that the drug product is misbranded due to e.g. false/misleading claims. In addition, it authors guidelines to enable a sponsor to create promotional material that is in compliance with the "general rules" given in 21 CFR 202.1.
In June 2018, FDA finalized two ground-breaking guidelines, one for communication of medical product information to payors and another one on how to communicate information that is consistent with FDA-required labeling. These guidelines have the potential to change the regulatory landscape of prescription drug advertisement, allowing a sponsor to include information that is not contained in the drugs FDA-required labeling, but that is consistent with this labeling.
This master thesis provides an introduction on regulations and guidance that govern promotional material in the US and that is overseen by FDAs Office of Prescription Drug Promotion. In addition, a short overview on recent Warning and Untitled letters issued in relation to promotional activities is given.  
Pages: 53