Marketing and promotion of drugs and medical devices

Regulation of the promotional aspects of prescription drugs, biologics, medical devices and biotechnology products with the intention of ensuring that the information contained in the promotion material is not false or misleading is one of the chief objectives of the FDA.

The FDA regulates the promotional materials of all drugs, and this includes both labeling and advertisements. Brochures, booklets, detailing pieces, bulletins, calendars, motion pictures and slides are some of the examples of labeling, while materials published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television and telephone communications systems are examples of advertising.

The FDA also regulates another avenue of drug promotion and advertising, namely detailing. This kind of promotion is the one that pharma companies do to doctors in a variety of venues such as medical offices, hospitals, pharmacies, at medical meetings and symposia, academic settings, conferences and other meeting facilities.

The FDA’s reach in monitoring and regulating promotions also covers direct-to-consumer (DTC) prescription drug advertising. In this area, it has complete jurisdiction over prescription drug labeling and advertising and all medical device labeling, but has limited jurisdiction over medical device advertising.

Severe penalties for offenders

For decades, the FDA has been regulating traditional advertising, during the course of which it has been publishing several kinds of guidance documents for industry, and has issued many violation letters. The corrective actions that companies have to implement if the FDA adjudges that drug or medical device promotional material is false or misleading or does not give a proper account of the product needed to enable consumers to weigh the benefits and risks are very expensive and time consuming. They have to carry out expensive remedial advertising, have to cough up huge fines, and also face the prospect of having their reputation sullied on account of these enforcement actions from the FDA.

In addition, it can also criminally prosecute relevant executives of such organizations under the provisions of a strict liability standard. This law gives the government sweeping powers, by which it is not obliged or required to show that the executive facing prosecution had the intention of violating FDA regulations or was knowledgeable about such violations.

The agency has already netted billions of dollars in fines, forfeitures and disgorgements from drug companies for the alleged marketing of a product for unapproved, or “off-label,” uses.

Are the FDA’s laws obsolete?

Yet, the general consensus is that the law governing drug and device marketing is both outmoded and insufficient to deal with the speed at which technology-enabled promotion campaigns appear out of nowhere and disappear in a jiffy. Experts feel that the FDA is still very conservative and traditional in adapting technologies needed for detecting and nailing down such promotion campaigns that technology has brought about. Naturally, the regulatory circles are eager to see how the FDA will deal with the advanced communication technology that goes into promotion campaigns that can make the advertisement go viral and leave the scene just as quickly.

These are important aspects for organizations in the drugs, biologics, medical devices and biotechnology areas. These companies need to be completely aware of the law governing advertising and need to understand the FDA’s thinking on what it considers false and misleading advertising. This knowledge is absolutely essential, considering the broad sweep of powers that the FDA has.

Important learning on the FDA’s approach to promotions and advertising

This important understanding will be imparted at a two-day seminar that is being organized by GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance. At this seminar, David R. Dills, Global Regulatory Affairs and Compliance Consultant, who provides regulatory affairs and compliance consultative services, will be the Director. To gain insights into the FDA’s thinking on how it perceives advertisements and promotions as false and misleading, please register for this seminar by visiting Marketing and promotion of drugs and medical devices. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Advertising aimed at healthcare professionals and consumers

Prescription drug promotion is aimed at and delivered to two distinct audiences: Health care professionals (HCPs) and consumers. The FDA recognizes that promotional efforts can provide these audiences important information about the newest developments in drug therapies. So, it insists that such information has to have integrity and completeness.

Also, healthcare professionals, sales representatives and consumers use the social media to discuss the use of prescription products for specific diseases and conditions, a factor that has to be taken into account. David will discuss this and the potential concerns it carries.

Validation in accordance with ICH guidelines

Chemical

Professionals in the field of statistical analysis need a clear and perceptive insight into how to understand and interpret statistical concepts used to investigate quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits. Along with these, process and quality controls, as well as ICH Q8 and Q9 also need to be properly and thoroughly understood.

The ICH tripartite-harmonized ICH Guideline on Text, which was previously coded as Q2A, finalized in October 1994 under Step 4, is the guideline the ICH has set out for analytical methods validation. The aim of this guideline is to identify the validation parameters that are required for a number of analytical methods. This guideline also lays down the characteristics and parameters that need to be taken into consideration when validating the analytical procedures that are included in the registration applications.

Likewise, the ICH tripartite-harmonized ICH Guideline on Methodology, which used to be previously coded as Q2B, finalized in November 1996 under Step 4, is the ICH guideline on procedures and acceptance criteria in calibration limits. This guideline extends the ICH guideline on Text, or what is called Q2A (mentioned above) to comprise the actual experimental data required, along with the statistical interpretation, for the validation of a variety of analytical procedures.

Current Step 4 for process and Quality Control

For process and Quality Control, the extant guideline is the Current Step 4 version of the ICH-harmonized Tripartite Guideline. The final draft of this guideline has been recommended for adoption to the regulatory bodies of the three biggest pharmaceutical markets in the world, namely the US, the EU and Japan.

In order to achieve harmonization in Quality, professionals have to meet critical milestones. These include conducting stability studies, the way the studies define relevant limits for the testing of impurities, and following a more malleable approach to pharmaceutical quality that is based on the principles of Good Manufacturing Practice (GMP) risk management. ICH’s Quality guidelines on harmonization relating to Quality cover the following areas:

Get professionally trained on the areas of Validation in accordance with ICH guidelines

Considering the complexity and the breadth of the issues associated with these techniques, which cover both the pharmaceutical and clinical applications, and considering that these techniques apply to a number of area such as stability testing, outlier analysis and risk management; it is necessary and important to undergo professional trainings with which professionals in these areas can clarify a number of doubts.

This is the learning a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be imparting. This training will be led by Dr. Alfred Bartolucci, who serves as Emeritus Professor of Biostatistics at the University of Alabama. To enroll for this seminar, please register by logging on to Validation in accordance with ICH guidelines . This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A clear and deep understanding of statistical concepts

Depth and clarity of understanding of the statistical concepts used for investigating quantitative ICH Guidelines such as analytical methods validation, procedures and acceptance criteria in calibration limits, and process and Quality Control, along with ICH Q8 and Q9 will be the main thrust of this seminar.

This seminar is not a course in statistics, but offers an introduction to an applied approach to the statistical techniques used, and how to reasonably interpret them. This learning will help participants address the various challenges facing pharmaceutical and biotechnology companies when they have to quantify results in a meaningful interpretable manner through tabulations and graphical presentations.

In addition, Dr. Bartolucci will also focus on another important area: What the different regulatory agencies expect of the quantification and development of a sound statistical monitoring of a properly utilized, effective, and efficient process control. He will familiarize the participants with the critical aspects of the statistical methods and explain to them the practical application of these guidelines.