Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs

Name of Guidance:
Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs

Status of Guidance:
Final

Name of Organization:
Food and Drug Administration
Center for Devices and Radiological Health

Date of Guidance:
April 2008

Target Audience:
Sponsors submitting IDE applications for artificial disc devices and FDA staff reviewing these applications

Laws and Regulations Referenced:

21 CFR 812.20 Describes when and how a sponsor should file an
Investigational Device Exemption (IDE) application
21 CFR 812.25 Outlines what should be included in a device investigation plan
21 CFR 812.27 Describes what should be included in a report of previous
investigations when submitting an IDE application
21 CFR 812.43 Describes how study investigators and monitors should be selected
21 CFR 860.7 Explains how device classification is determined based on safety and
effectiveness data
21 CFR Part 50 Describes how human subjects must be protected during clinical trials
21 CFR 50.25 Outlines what is involved in obtaining informed consent from subjects
in clinical trials
21 CFR Part 58 Explains what constitutes good laboratory practice for nonclinical
studies

Definitions:

Total artificial disc – An implant that replaces a vertebral disc in the human spine

Spinal system – The complete spinal implant including all parts

Component – An individual part of a spinal implant

Construct – The entire spinal implant system
Device/system – Interchangeable terms referring to the artificial disc

Background:
The artificial disc was first approved in the United States in 2004 to treat certain disorders of the spine.¹ The US Food and Drug Administration (FDA) still considers the artificial disc to be a new technology.^2(p13) Before the FDA will consider approving a new artificial disc, or an existing disc for a new use, the device must be tested in animals and humans. Because artificial discs pose substantial and unique health risks to patients, the FDA must grant permission before human studies are conducted. This permission is called an Investigational Device Exemption (IDE). In this guidance, the FDA issues recommendations specific to applying for an IDE for a total artificial disc device.

Summary:
This guidance provides recommendations to those who wish to apply for permission to test artificial discs in humans. The guidance outlines each section of the IDE application, and explains what type of information should be included.

The IDE application should begin with a detailed description of the artificial disc, including photographs, drawings, and material specifications. Following this description, the authors should include all information already known about the device or similar devices. This section, entitled Report of Prior Investigations, should describe previous results from testing in animals and humans. Animal data should establish that the device poses a minimal risk of toxicity, and provides basic functionality and performance over time. A variety of animals are used to test spinal devices, and the investigators must provide a rational for their choice of animal model.

The IDE should address the issue of wear debris, which is a major area of safety concern. Normal wear may cause the device to break down on a microscopic level, releasing particles of foreign material into the body. Investigators must test the effects of such particulate matter in animals prior to testing the device in humans.

Artificial discs are designed to preserve the motion of the spine, as opposed to traditional spinal fusion, in which motion is eliminated. Mechanical testing of the artificial disc should establish its ability to preserve the 6 primary motions, which are lateral bending (to the left and right), flexion and extension (to the front and back), and axial rotation (twisting left and right). The testing parameters should be presented in detail, any device failures documented, and the results interpreted.

Mechanical testing should be conducted, with results measured after 10 million repetitions of a given motion. The maximum range of motion the device allows should be documented. Such testing is typically performed using cadaver specimens.

Mechanical testing should also verify that the device is not prone to migration (moving out of position), or stress relaxation (in which the more flexible components of the device stretch out and lose elasticity over time). Testing should further establish that the surrounding bones of the spine (vertebrae) grow into the areas in which they come in contact with the device, providing stability (osseointegration) over time. They must also show that any coatings applied to the device do not wear off or break down over time.

Finally, prior investigations should examine the shelf life of the device to determine whether the components degrade with age.

The next section of the IDE application outlines the investigator’s plan to conduct a human study. After outlining the purpose of the study, the application should describe the design of the study in detail. The FDA recommends various criteria for including and excluding potential study participants. Many of these criteria relate specifically to the condition of the patients’ spines. Patients may be excluded because they have complex and interconnected spinal disorders, which would make it difficult to assess the performance of the device to be tested.

The FDA also addresses the fact that very few studies have tested the use of artificial discs at more than one spinal level in the same patient. They recommend that, if multi-level disc replacement is studied, enough patients are included to provide useful data, and that results be analyzed separately for patients with a one- and multi-level treatment.

The guidance describes various spinal problems that should exclude a patient from participating in a study of artificial discs, but allows the investigators to include such subjects if they provide an acceptable rationale.

The FDA recommends that subjects be followed for at least 2 years after surgery. They also recommend asking patients to consent to long-term follow-up that may continue for 5-10 years.

The guidance describes in detail the ways in which the failure or success of the device may be determined. These include x-ray images of device positioning, bone ingrowth, and spinal motion, as well as evaluations of the health of the spinal levels above and below the implant. They also include patient surveys about pain and their ability to perform daily activities.

The guidance lists potential risks that test subjects may face, some related to surgery, and others related specifically to the artificial disc. It recommends the IDE applicant address how the study design minimizes these risks.

In the interest of providing information on the long-term use of artificial discs, the FDA also recommends that any devices that are eventually removed from patients be analyzed.

Finally, the IDE application should include proposed packaging and surgeon instructions for the artificial disc. These instructions should describe not just the implantation of the device, but also the removal of the device or revision of the surgery if required.

Rationale:
This guidance provides important detail that is useful in submitting an artificial disc IDE. Artificial discs pose numerous safety risks and their effectiveness remains controversial. Therefore, it is appropriate that the FDA describe its specific areas of concern about these relatively new devices, and guide applicants in addressing them through appropriate testing, analysis, and documentation.

Resulting Recommendations:

· The investigator’s choice of animal model should be justified by providing a description of its relevance to the expected human use of the artificial disc.

· Wear debris should be evaluated in a small animal model and after 10 million repetitions of a given motion in a cadaver specimen.

· Animals should be studied after 3 and 6 months of device implantation.

· The range of motion allowed by the artificial disc should be documented.

· Artificial discs should be evaluated for their tendency to migrate or slip out of position.

· The durability of any coatings applied to the artificial disc should be tested.

· The shelf life of the artificial disc should be evaluated.

· Clinical trials should involve multiple centers, control groups, and patient randomization to test the safety and effectiveness of artificial discs.

· If artificial discs are to be implanted at more than one level in a single patient, the study should include enough such cases to provide adequate data, and these data should be analyzed separately from single-level cases.

· Patients should be excluded from the study if they have less than 5 mm of disc height between vertebrae, if they have a spinal problem other than the one being studied, if they are taking medications affecting bone metabolism, if they have myelopathy (spinal cord disorder),³ if they have certain degenerative diseases or deformities of the spine, or if they have had certain prior spine surgeries.

· Patients should be followed for at least 2 years after surgery, and preferably for 5-10 years.

· Endpoints for studies should include back, leg, neck, and arm pain, ability of patients to perform daily activities, device stability, amount of spinal motion, bone growth into device, disc height, and overall satisfaction of the patient.

· Successful bone ingrowth should be defined as covering at least 75% of the implant contact surface.

· Studies should examine the relationship between range of motion and pain to determine whether the preservation of motion is associated with reduced pain.

· Levels of the spine above and below the implant should be assessed for their disc height and range of motion.

· Studies should be designed to minimize patient risks, including breakage or slippage of the artificial disc, fracture of bone adjacent to the implant, loss of spinal motion, undue wear of the device, degeneration of adjacent vertebrae and discs, infection, and neurological side effects.

· Devices that are surgically removed should be studied for wear.

· Device packaging should include surgical instructions not only for implanting the artificial disc, but also for removing it or revising the original surgery.

Impact:
Artificial discs have the potential to treat a variety of spinal disorders while preserving motion in the spine. New devices may provide significant improvements on original designs, and their safety and efficacy must be studied in humans before widespread use. Moreover, the long-term effects of artificial disc implantation must be examined. To these ends, this guidance provides useful advice to device manufacturers and investigators who wish to obtain FDA approval to test their artificial discs in humans.

1. Feder BJ. An Alternative to Spinal Fusion. New York Times. December 24, 2004. Accessed May 23, 2011.

2. U.S. Food and Drug Administration. Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs. April 11, 2008. Accessed May 19, 2011.

3. Myelopathy. The Free Dictionary. Accessed May 23, 2011.

Brief Summary: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro

Name of Guidance

Brief Summary: Drug Metabolism/Drug Interaction Studies in the Drug Development Process: Studies In Vitro

Status of Guidance

Final Guidance

Date of Guidance

April 1997

Released by

Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research

Link to the Guidance

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072104.pdf

Target audience

Developers of drugs or biologics

Laws and Regulations

No laws or regulations were referenced in this guidance.

Definitions

Genetic polymorphism: A genetic variation that results in different forms or types of individuals among the members of a single species.

Excretion: The removal of a waste product of metabolism.

Metabolite: Any product of metabolism.

Prodrug: A substance that becomes a pharmacologically active after being chemically converted through metabolic processes.

Background

Drugs entering the body are eventually removed from the body. This can happen in one of two ways. One way is through the outright elimination of the drug through the process of excretion. The other way is through metabolism in which the drug is modified into one or more active or inactive metabolites. In addition, a drug can also interact with other drugs or foods a patient may be taking concurrently, causing the drug’s effect to be decreased (inhibited) or increased (induced), or causing the other drug’s effect to be inhibited or induced.

Summary

This guidance advocates investigating whether a drug is excreted unchanged or metabolized (and by what metabolic pathways) as early as possible (eg, before phase 2 testing) to determine how the drug is affected once it is in the body, including potential drug-drug interactions. This guidance pertains to drug molecules with a molecular weight <10 kD.

Rationale

It is important for a drug developer to know how a drug is removed from the body (by excretion or metabolism) because the process can significantly determine the safety and efficacy of a drug and, thereby, determine how it should be used. When a drug is metabolized, it may go through one or more metabolic (enzymatic) pathways, producing a modified form of the drug, called a metabolite.

If a drug is metabolized, it is necessary to know which metabolic route/routes are involved because genetic variations (aka genetic polymorphisms) from one person to the next can influence the rate of metabolism and potentially cause large differences in the concentrations of the drug and its metabolite in the blood. These differences can mean the difference between a safe drug concentration within the designated therapeutic window, a low concentration in which the drug will not have a therapeutic effect, or a high concentration in which the drug level will be toxic. Knowledge of a drug’s route(s) of metabolism can help a drug developer determine proper doses and necessary dose adjustments to ensure safe and efficacious use of the drug. It is also necessary to know about the nature of the metabolites produced by the metabolic process.

Resulting Recommendations

The FDA recommends drug developers to consider the following approaches to in vitro studies of drug metabolism and drug interactions:

1). Investigate metabolic processes (including route[s] of metabolism) and drug-drug interactions as early as possible in the drug development process, ideally prior to phase 2 studies (eg, as early as pharmacokinetic/phase 1 studies). The data produced will enhance the design of subsequent studies regarding clinical dose/response, interaction, and special populations.

2. Allow more concomitant drug use during studies early in the development process.

3. Identify significant metabolites and prodrugs and their pharmacological properties.

4. Identify metabolic differences in patient groups based on genetic polymorphisms, or other demographic factors (eg, age, race, gender). Doing so will assist in determining proper dosing in different patient populations, and, ultimately, dose adjustments.

5. Use the information gained from early identification of metabolic routes of elimination and metabolites in in vitro studies to guide the design of preclinical studies in animals to compare drug and metabolite exposure in humans and animals. Also conduct these studies in animals early in the course of drug development, as the information obtained can be used to help plan and interpret later clinical studies.

6. Give precedence to results from in vivo studies over results from in vitro studies. However, if in vitro studies determine that certain metabolic pathways are not involved in the elimination of a drug, in vivo testing may be unnecessary.

7. Conduct in vitro studies of drug at concentrations that will be relevant in vivo to identify if other substances inhibit or induce the effect of the drug.

8. Label for class effects for various metabolic enzymes. Use the data gained in in vitro studies about metabolic pathways to draw generalizations about what substances the drug may interact with and include this in the product labeling. For example, knowing that the drug is metabolized by CYP450 enzymes, certain inhibition and/or induction interactions can be expected, and dose adjustments may be necessary. Fully disclose on the labeling if generalizations are being made from in vitro studies.

Impact

Compliance with this guidance should help drug/biologic developers plan efficient, cost-saving drug testing plans, allowing them to gain an understanding of metabolic pathways and potential drug interactions early on in a drug’s development (eg, in the in vitro stage). Gaining this knowledge early in a drug’s development will help eliminate unnecessary subsequent testing that would be costly and inefficient at a later stage (eg, clinical) of development.

Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs). Waiver of IRB Requirements

Name of Guidance:
Information Sheet Guidance for Sponsors, Clinical Investigators, and Institutional Review Boards (IRBs). Waiver of IRB Requirements for Drug and Biological Products Studies.

Status of Guidance:
Final

Date of Guidance:
January 2006

Name of Organization:
United States Food and Drug Administration (FDA)

Target Audience:
Clinical trial sponsors and clinical trial investigators

Laws and Regulations Referenced:

• 21 Code of Federal Regulations (CFR) 10.115 – The FDA’s administrative practices and procedures regarding the use of good guidance practices. The guidance under review cites that it is in line with FDA’s regulations.
• 21 CFR 50 – This regulation addresses the need to protect human subjects that participate in clinical trials. The guidance under review does not apply to the informed consent section of 21 CFR 50.
• 21 CFR 56 – Institutional Review Board (IRB) requirements in clinical trials. The guidance under review is an addition to the waiver in section 21 CFR 56.
• FDA section 505 (i) – FDA Regulatory information regarding exemptions for research of new drugs. The guidance under review states that it remains under the discretion of the FDA to grant IRB exemptions.

Definitions:

Agency – When referring to pharmaceuticals, the agency is the government entity overseeing the development of medications. In the United States, the Agency refers to the Food and Drug Administration.

Clinical trial or clinical study– Process by which the efficacy and safety of a medication is tested in humans.

Clinical trial investigator or investigator – Medical doctor overseeing the clinical trial

Clinical trial sponsor or sponsor– Company paying for all expenses of the clinical trial

Code of Federal Regulations – Laws created by congress.

Guidance – When referring to pharmaceuticals, these are recommendations from the FDA.

Independent Ethics Committee (IEC) – Committee that approves, monitors, and reviews all aspects of a clinical trial involving humans. They are normally found in Europe and they comply with most FDA requirements.

Informed consent – Information given to the patient regarding a treatment or procedure. After receiving the information, the patient decides whether he or she would like to undergo the treatment or procedure.

Institutional Review Board (IRB) – Performs similar functions to the IEC. They are normally found in the United States.

Study protocol, trial protocol, or protocol – Document that describes all aspects of a clinical trial. It gives the background of the product or procedure being tested. It describes what the sponsors hope to accomplish the trial and how they will go about it.

Background:
Clinical trials are conducted all over the world. In the United States, a physician needs to obtain approval from an IRB before he or she is able to participate in a clinical trial. All of the details of a clinical trial are outlined in the study’s protocol. However, when the company sponsoring the clinical trial is located outside the United States, the protocol might call for an IEC instead of an IRB. This guidance was created to address this issue.

Summary:
This guidance provides information to a sponsor on what is needed to obtain an IRB waiver. In order to grant the request, the agency has two main requirements:

1. Reason why a waiver is necessary
2. Description of alternative methods of guaranteeing the safety of all participants in the study

Most requests received by the agency are from sponsors utilizing IECs instead of IRBs.

The sponsor must submit the request in writing to the appropriate division of the FDA. A written response will be sent to the sponsor regarding the waiver’s request decision. A copy of all communications must remain in the investigator’s files.

Rationale:
This guidance was created because under the Federal Law of the United States, IRB approval is necessary before a study can begin for an investigational new drug. This requirement is in place for the safety of all study participants. However, in some countries, IRBs do not exist. Instead, IECs are used for the protection of study participants.

Resulting Recommendations:
Sponsors are able to use IECs to conduct a clinical trial but they must obtain a waiver from regulatory authorities prior to starting the study.

Impact:
Obtaining this waiver may delay the starting of a study.

Social Media Promotion in an FDA Regulated World -- Part (iv)

This is the fourth (4th) and final part to the blog series relating to social media in an FDA regulated world. This section deals with what the FDA is unlikely to want to regulate, and how to potentially tackle some of the communication problems associated with social media promotions.

Part IV

What is not likely to be regulated?

As important as knowing what is likely to be regulated, is knowing what the FDA is unlikely to want to regulate.

Source documentation that your consumers will not see:

The FDA’s core mission includes being “responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” In furtherance of this mission, the FDA regulates, via divisions in CDER, CBER and CDRH, information that is distributed to consumers and healthcare providers.

However, information such as software code, including specific meta-tags that are typically unavailable to the typical consumer/ healthcare provider, will be unlikely to be targeted by the FDA, and will likely be deemed to be unworthy of its attention and enforcement.

Resultantly, while we may see additional examples of the FDA looking at meta-tags and evaluating whether specific meta-tags may be misleading, it is unlikely that the meta-tags in evaluated so far have constituted a “game changer” in that they were available and viewable to the general public.

Where does that leave us?

As we discussed, a marketing strategy that includes the internet, as it now necessarily should, will require an assessment of the internal capabilities of the company. A typical marketing and promotions meeting has always included clinicians, lawyers, regulatory folk and marketing folk from both the strategic divisions and from the print and broadcast media sections. It is important to understand and appreciate that other folks may be necessary in these meetings.

Multi-Disciplinary Team Members

There are multiple parties involved in meetings relating to promotional compliance. These parties, as previously suggested, may include lawyers, clinicians, regulatory and marketing individuals. These individuals or teams each have their own jargon and communicate in ways that are unlikely to be understood by other individuals at such meetings. This jargon, and varied understanding, heightens the risk of miscommunication between the parties. This risk of miscommunication often maximizes the chances of problems occurring, and in the event of an actual problem may result in finger pointing and blame shifting. It is hence important that multidisciplinary individuals who can communicate across multiple subject matters be at the table to “translate” for other team members. Typically, such individuals must necessarily have not only an understanding of the clinical discussion but at least one if not more other factors that must be considered by other members at the meeting. This ability to translate for other members will allow for team building and rapport generation and provide the teams the ability to work through any possible mis-communications, resulting in decreased violative content being allowed to “pass through” such promotional meetings.

Social Media Promotion in an FDA Regulated World -- Part III

This blog entry, is a continuation of two (2) previous entries. It will be discussing specific themes, and the likely position of the FDA relating to these specific themes as explained below. 

Themes:

Due to the continually changing nature of the Internet, the FDA has indicated a reluctance to address its guidances specifically to how a promotion on twitter or facebook should look, and will instead address themes such as “responding to unsolicited requests”. The expected, aforementioned guidances from the FDA are therefore expected to be “platform independent.”  The following section details what we know, and theorizes on what the FDA is likely to propose in the coming weeks and months.

Medium neutrality

As previously mentioned, the rules haven’t changed. The FDA has indicated a continued desire to regulate, as it always has, the content and not the medium of distribution. The internet is, in many ways, like a combination of a television, radio, and print promotional piece, with the interactivity of an individual sales person. The FDA has outlined, in its guidances, how it treats, television, radio and print promotional pieces. It has also outlined  interactivity, to the extent it was relevant at the time, to the activities of sales people and medical liaisons. In light of the FDAs expressed opinions that it is unlikely to change its requirements, based on the mode of distribution of information, the FDA is unlikely to steer wide of those previous recommendations.

Whatever your consumer sees.

There have been several commentators who have reviewed the FDA warning letters and asserted that the Tasigna FDA warning letter[2] has allegedly “changed the rules” since it looks at meta data. I believe that it is too soon to tell if the rules have genuinely changed.

Meta data, in general, is usually information that is not visible to the general public unless certain unusual acts are taken (such as reviewing the code itself). There is, however, another class of meta-data, that is usually kept away from the public until such time as the intended audience acts in a way, desired by the promotion designer, that would force the reveal of this “hidden” information. The meta-data in question, in the Tasigna Warning Letter, was of the second type.

In the Tasigna Warning letter, the meta-data in question, when revealed by the audience, resulted in writing that the FDA deemed to be “misleading” because “it [made] representations about the efficacy of Tasigna but [failed] to communicate any risk information associated with the use of this drug.” This seems entirely consistent with the FDA’s position that misleading information would be considered to be worthy of its attention and enforcement power. There is no indication that this was in any significant way different from several other DDMAC enforcements over the years. The takeaway continues to be: the FDA expects a fair balance of risk and benefit information.

Reporting adverse events as reported online

As previously indicated, the FDA has typically required that to report individual adverse events, typically referred to as an individual case safety report or “ICSR”, the following minimum information must be available: (1) and identifiable patient (2) an identifiable reporter (3) a suspect drug and (4) a description of the event.[3] If these criteria are met, the adverse event is generally reportable. Considering the anonymous nature of the internet, these criteria may often not be satisfied since the reporters and/or patients may use anonymous identities that would preclude a pharmaceutical company being able to contact the appropriate reporter/patient for further information. Nevertheless, it is expected that if all the information is provided, the ICSR must be appropriately filed.

The next entry will relate to what is not likely to be regulated by the FDA, and conclude with some advice for sponsors on who they may want in their next marketing meeting.

Social Media Promotion in a FDA regulated World -- Part 2

This section focuses on the FDA's opinion of social media and promotion via the internet in general and social media in particular. 

FDA’s Opinions

Introduction

The FDA has often hinted that it treats social media the same as every other type of media. Early indications of this “medium neutrality” has been seen in enforcement actions against several pharmaceutical innovators. Specifically, in the case of social media, this message has been communicated in enforcement actions relating to youtube and facebook.

The FDA’s enforcement actions against individual companies and based on specific violative promotions may not necessarily indicate its official position against companies in general. Nevertheless, these enforcement actions provide us with informal indications of how it intends to respond to similar stimuli.

For the most part, a “take away” that has often been seen is: If the consumer/ intended audience can see, hear or have the company message hinted at, the FDA considers to “fair game” to assert that such a message reflects the company’s “official position”. While “seeing” and “hearing” are difficult enough to control, the “hinted at” portion of promotional pieces is particularly worrisome since what constitutes a “hint” has not been objectively well defined.

Impact and Fines

While the FDA, HHS and the DOJ have long had the authority to go after illegal activities by pharmaceutical companies, and have often used this authority, the last two years have demonstrated the FDA’s renewed focus and zeal associated with the enforcement against such activities. While such enforcement activities were often limited to audit reports, untitled letters and warning letters culminating in corporate integrity agreements, the stakes are much higher this time around. Some of the notable enforcement activities have included combining forces with the Federal Trade Commission (FTC), and engaging in enforcement proceedings against “responsible corporate officials” in combination with the Department of Health and Human Services (HHS) [4] and Department of Justice (DOJ)[5].

What is likely to be Regulated?

41% of surveyed individuals said that they use social media as a source of health care information.[6] A significant portion of this information necessarily includes the drugs and devices that these individual may either already be using or are actively considering using. The FDA recognizes these changes in information gathering methods, and seems to understand that there are limitations imposed by this “new media”. It has nevertheless continued to maintain that information provided by pharmaceutical companies is subject to the same rules irrespective of how the information is distributed. While this consistency relating to “medium neutrality” is useful for many, the interactive nature of the Internet causes significant problems particularly resulting from the innate interactivity associated with the internet, and limitations in disclosures that such media necessitate .

The FDA has indicated that it intends to address several of these concerns with multiple guidances it intended to originally release starting in 2010. The release dates of those guidances have, unfortunately, now been pushed into the first quarter of 2011.[7] This write-up intends to address some of the impending guidances and the potential directions it may take.

The next blog posting shall focus on specific themes that the FDA is likely to follow in the regulation of this "new media." 

Social Media Promotion in an FDA regulated world-- Part 1

There have recently been a spate of warning letters, fines, corporate integrity agreements (CIAs), against pharmaceutical companies and individual actions against people working in the pharmaceutical industry. Several of these penalties have related to illegal promotions and alleged off-label discussions. Nevertheless, because the industries patient's continue to seek health information online, these companies must continue to risk significant penalties to ensure that their patients get the most accurate information possible, via a medium that the patient considers desirable. Resultantly, the industry continues to promote its products online, via various methods including social media, despite what the industry, and the FDA, consider to be inadequate guidance.

This blog is hence the first in a series of related blogs relating to social media and promotion via social media, and what is the likely future of social media in an FDA regulated environment.

Introduction

According to a Harris Interactive Poll: 88% of online Americans look for health information online, with 45.2% of respondents of a burst media poll saying that the internet is their primary source of health information. In light of the significant amounts of incorrect information available online, pharmaceutical companies not only have a duty to help educate their patients, by providing them with the right information, but also have a duty to make this information easy to access and in a medium that these patients expect to find this information.
Pharmaceutical companies realize this necessity and have hence taken steps beyond simply using television or radio advertisements or even posting a static web-page. Many pharmaceutical companies have expressed an interest in engaging their potential patients in a two way discussion. However, in the absence of specific FDA guidance, that discuss how pharmaceutical companies should deal with social media, and in light of the significant warnings, fines and penalties that the FDA and other governmental agencies have imposed, many pharmaceutical companies are hesitant to jump into these perilous, “shark infested waters.”

What is social media?

While individuals in the pharmaceutical companies often agree that “social media” is the "newest, latest and greatest” form of communicating with their patients, few have defined what that term “social media” means. The term “social media” typically brings to mind, the abstract requirement of requiring the use of the internet to communicate. Some would argue that there must be some element of “mobility” associated with the media. Others suggest that there must be a significant portion of interactivity for the medium to be considered “social media”. Others yet argue that social media must have some element of being device neutral and not being necessarily tied to the apple operating system, chrome operating system or windows operating system. Others point to specific platforms, like linkedin, twitter and facebook, and assert that these platforms are “social media” never quite alienating what is not considered to be “social media.” We will be defining Social Media in the abstract: merely as tools and platforms that use the internet as a channel for communication. Such tools not only include linkedin, twitter and facebook, but also include patient communities, blogs, discussion boards, chat room discussions and websites.

Current State of the Art

The United States is part of an exclusive group only two countries that allow Direct to Consumer (DTC) advertising of specific prescription drug products. However, this special treatment carries with it several rules and regulations that must be followed. Specifically, in the event of a DTC promotion discussing a specific drug, a drug company must make significant disclosures in accordance with FDA requirements.

In the alternative, not directly talking about a specific drug, for example by discussing a disease state, affords pharmaceutical companies some flexibility relating to the type and extent of disclosures and risk information that must be shared. These non drug specific advertisements are not ideal since they do not promote an individual product. Nevertheless, they carry certain advantages including (1) a reduction in necessary risk discussions, (2) flexibility of the message communicated and (3) limited liability associated with such an advertisement. Additionally, such promotions allow companies to directly connect and interact with the needs of their patients. Resultantly, several drug companies actively supporting patient communities built around specific disease states, in addition to promotions of specific drugs.

In the next posting, we will be discussing the FDA's position on promotion via the internet.