Life Science Compliance Update

February 12, 2018

FDA Announces Study on Consumer and HCP Deception Perception

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In December 2017, the United States Food and Drug Administration (FDA) announced plans to study whether consumers and healthcare professionals have the ability to “spot and report” deceptive prescription drug promotion practices.

Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to review everything. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion, a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA.

The FDA’s Office of Prescription Drug Promotion (OPDP) seems to be looking to the public to help it monitor deceptive drug promotion. This study would assess whether consumers and healthcare professionals (HCPs) are able to “identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA.”

The proposed project involves two studies examining volunteer participants’ ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. HCPs will view mock pharmaceutical websites targeted toward physicians while consumers will view mock consumer-targeted pharmaceutical websites. The goal will be to keep the HCP and consumer-targeted websites as similar as possible, but to include content that is appropriate for the target audience. For example, HCP websites may contain medical terminology, whereas the consumer websites would utilize consumer friendly language.

The FDA believes the ability of consumers and HCPs to identify deceptive prescription drug promotion “has important public health implications,” as consumers who are unable to spot deceptive promotions may “ask their HCPs to prescribe specific drugs that they would not otherwise request.” Additionally, if HCPs are unable to identify deceptive promotion, they “may prescribe specific drugs that they would not otherwise prescribe.”

However, OPDP notes that, “on the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action.”

Once completed, the proposed studies will provide data on whether consumers and health care professionals can identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA. Although both studies will assess consumers and health care professionals, one study will focus on the degree of deception in an ad while the second study will focus on implied versus explicitly deceptive claims.

“Promotional material that drug makers share with patients and providers can be a helpful tool for encouraging patients to seek medical care and raising awareness about new and different treatment options,” said FDA Commissioner Scott Gottlieb, M.D., in an “FDA In Brief” release. “The FDA plays an important role in helping to make sure these presentations are truthful, balanced, and nonmisleading, and we need to study promotional material to constantly improve our oversight over these activities. A key to our oversight is recognizing claims in prescription drug promotion that have the potential to deceive or mislead consumers and health care professionals.”

This most recent study is reminiscent of the aforementioned Bad Ad program that was launched in 2010 – a program that did not yield significant enforcement activity.

February 05, 2018

FDA Releases Guidance on IND Sponsors

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In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs. The guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD).

Guidance

Communications between FDA and industry are often opportunities to share information on clinical trials and for the agency to provide advice on trial design, dose selection, nonclinical study requirements, and manufacturing and facility issues. It is important that agency-industry interactions “be conducted efficiently and consistently, with clear, concise, and timely communication,” FDA says in announcing the guidance.

Pre-IND Meetings

Pre-IND meetings, which can prevent clinical hold issues, can be valuable for understanding proof of concept and initiating dialogue with the agency as the company develops a complete IND submission.

“FDA encourages sponsors to request a pre-IND meeting for the following: a drug not previously approved/licensed, a new molecular entity (NME), a planned marketing application intended to be submitted under the 505(b)(2) regulatory pathway, drugs for which it is critical to public health to have an effective and efficient drug development plan (e.g., counter-terrorism), drugs with substantial early development outside the United States, a planned human factors development program, and drugs with adequate and well-controlled trials to support a new indication,” FDA says.

FDA further says it “encourages sponsors to request pre-NDA/BLA meetings for all planned marketing applications, particularly applications to be reviewed under the PDUFA V Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs.”

Interaction with FDA

The review division regulatory project manager (RPM), who has comprehensive knowledge of the drug and its regulatory history, is the primary point of contact for communications between IND sponsors and FDA during the life cycle of drug development. The RPM is the contact for facilitating the timely resolution of technical, scientific, and regulatory questions, conflicts, or communication challenges between the sponsor and the review team, FDA says.

Other project managers can include:

  • CDER’s Office of Pharmaceutical Quality regulatory business project managers, who manage meeting requests, regulatory submissions, and other inquiries related to chemistry, manufacturing, and controls, including facility and product quality issues;
  • CDER’s Office of Surveillance and Epidemiology safety regulatory project managers, who manage sponsor requests for proprietary name review; and
  • CDER’s Formal Dispute Resolution Project Manager, who manages sponsor requests for resolving scientific and/or medical disputes that cannot be resolved at the division level.

Types of Advice

During the life cycle of drug development, sponsors routinely solicit feedback from FDA on both scientific and regulatory issues. The breadth and frequency of advice sought can vary according to the experience of the sponsor, as well as the novelty and development stage of the proposed drug. During the IND phase of drug development, sponsors often solicit advice at critical junctures in their development programs. These topics include, but are not limited to the following:

  • Regulatory (e.g., plans for submission of proprietary name requests, plans to defer or waive specific studies, development plans with other FDA centers (e.g., the Center for Devices and Radiological Health) for combination products), applicability of an expedited program;
  • Clinical/statistical (e.g., planned clinical trials to support effectiveness, validity of outcomes and endpoints, trial size, enrichment designs);
  • Safety (e.g., safety issues identified in nonclinical studies and early clinical trials, size of the overall safety database, concerns related to particular populations, post-approval pharmacovigilance plans, risk evaluation and mitigation strategies, plans for human factors studies, issues related to evaluation of abuse potential);
  • Clinical pharmacology and pharmacokinetics (e.g., dose selection, use in specific populations, drug-drug interactions);
  • Nonclinical pharmacology, pharmacokinetics, and toxicology (e.g., genetic toxicology, reproductive and developmental toxicology, carcinogenicity, mechanism of action); and
  • Product quality (e.g., proposed shelf life and stability studies, delivery systems, characterization of drug substance/product, facility compliance with good manufacturing practices, comparability of lots used in clinical trials and commercial lots); and
  • The proposed pediatric development plan and dosing.

Complex questions that involve interpretation of regulations and statutes, or the application of existing FDA policy to novel circumstances, can demand additional vetting and response time, FDA says.

More on Communication

FDA notes that the guidance does not apply to communications or inquiries from industry trade organizations, consumer or patient advocacy organizations, other government agencies or other stakeholders not pursuing an IND development program.

Regarding companies that fail to respond, FDA notes that later drug development can be negatively affected by sponsors’ delay or failure to respond to FDA, though the timing of FDA’s response may also be negatively affected if the review team experiences “an unexpected shift in work priorities or team staffing. In these cases, the FDA project manager will try to keep sponsors apprised of changes to the estimated response timeline.”

Regarding delays in obtaining FDA response, FDA advises the sponsor to contact:

  • The appropriate FDA project manager, typically the review division RPM, for a status update after the expected amount of time (e.g., the timelines described in a MAPP) for a FDA response that has passed;
  • The appropriate FDA project manager, typically the review division RPM, for a status update after the estimated response time has passed (i.e., the estimated FDA-response date communicated to the sponsor previously);
  • The appropriate FDA project manager’s next level supervisor for assistance in eliciting a response from the project manager; and
  • The appropriate division or office management officials for assistance in eliciting a response from the project manager; or
  • CDER’s or CBER’s Ombudsman for assistance in eliciting a response from the project manager.

August 08, 2017

FDA Issues Two Proposed Studies on Disclosures for Advertising

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Last month, the FDA issued two proposed studies on disclosures for advertising: one for general advertising and another for oncology advertising. Both studies have comment periods that end on August 18, 2017.

For both proposals, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

General Advertising

The Food and Drug Administration Office of Prescription Drug Promotion (OPDP) plans to investigate the way repetition and over warning apply to the presentation of risks in promotional prescription drug print pieces. They propose to test two levels of the Important Safety Information (ISI) – short versus long – and the presence of the Brief Summary in two different medical conditions (overactive bladder and rheumatoid arthritis). This will be investigated in DTC print ads for prescription drugs.

OPDP will collect descriptive eye tracking data on adult participants' attention to the following: (1) The important safety information, (2) the brief summary, and (3) the indication and benefit claims.

OPDP will conduct one 60-minute pilot study with 40 participants and two 60-minute studies with 200 participants each (50 participants in each cell), for a total of 400 main study participants. The studies will be conducted in person in at least five different cities across the United States. The pilot study and main studies will have the same design and will follow the same procedure.

Participants who self-identify as having one of the medical conditions of interest will be randomly assigned to one of four test conditions. In Study 1, the ad will be for a fictitious drug to treat rheumatoid arthritis. In Study 2, the ad will be for a fictitious drug to treat overactive bladder. After obtaining consent, they will explain the study procedure to participants and calibrate the eye tracking device. To collect eye tracking data, an unobtrusive glasses-based real-world eye tracker with a minimum speed of 50 Hertz will be used. The test images will be presented on paper and sized similarly to how they would appear in print materials such as magazines. To simulate normal ad viewing, participants will view two ads. One of the ads will be the study ad. The non-study ad will be for a consumer product unrelated to health. Only eye tracking data from the study ad will be analyzed. Next, participants will complete a questionnaire that assesses risk perceptions, risk recall, efficacy perceptions, efficacy recall, and covariates such as demographics and health literacy. In the pilot study, participants will also answer questions as part of a debriefing interview to assess the study design and questionnaire.

Oncology Advertising

FDA is proposing to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising for oncology products. The use of disclosures is one method of communicating information to health care professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and decision making, and may affect how and what treatment they prescribe for their patients.

According to the FDA, promotional labeling and advertising for cancer drugs deserve specific attention. Oncology drugs represented 26 percent of the 649 compounds under clinical trial investigation from 2006 to 2011.

Different aspects of disclosures may influence their effectiveness. For example, despite the advanced education of health care providers, in a busy practice they may not be willing or able to process the disclosures thoroughly. The level of technicality in the disclosure may play a role in their use of the disclosure to contextualize the data display. Additionally, the addition of a general summary statement to frame the disclosure may help or hinder the processing of the disclosure and therefore the entire data display.

The proposed study seeks to address the following research questions:

  1. Do disclosures mitigate potentially misleading presentations of preliminary or descriptive data in oncology drug product promotion?
  2. Does the language (technical, non-technical) of the disclosure influence the effectiveness of the disclosure?
  3. Does the presence of a general statement about the clinical utility of the data in addition to a specific disclosure influence processing of claims and disclosures?
  4. Do PCPs, oncologists, and mid-level practitioners (nurse practitioners, physician assistants) differ in their processing of claims and disclosures about preliminary or descriptive data?
  5. Which disclosures do physicians prefer?

To address these questions, the FDA has designed a study that will be conducted in three independent phases, each phase examining a data display in a promotional piece for a unique oncological product. Independent variables will include: (1) Specific disclosure (technical, non-technical, none), (2) general statement (present, absent), and (3) specialty (oncologists, PCPs, mid-level practitioners). 

Outcome variables will focus on the assessment of the data display as well as attention to the disclosure, if present. Specifically, recognition of the clinical endpoint in the data display, comprehension of the data display, perceptions of the exploratory nature of the data, and the perceived credibility of the promotional piece will be examined.

Oncologists, PCPs, and non-oncology mid-level practitioners will be recruited to participate via the Internet, and the study is expected to take approximately 20 minutes. Participants will view professionally developed promotional pieces that mimic currently available promotion and answer questions. The questionnaire is available upon request.

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