Life Science Compliance Update

August 28, 2017

A Murky Future for Off-label Promotion: New Leadership at the FDA Brings Change


On May 11, 2017, Dr. Scott Gottlieb was sworn in as the U.S. Food and Drug Administration’s latest Commissioner. Since that time, there has already been various regulatory changes and shifts, in terms of policy guidance, as well as a new focus toward easing the Agency’s rules and regulations pertaining to off-label uses. The article will explore those changes and the Agency continues to refine the “intended use” rules.

The U.S. Food and Drug Administration’s (“FDA”) Twenty-Third Commissioner, Dr. Gottlieb, is a man of many talents. He is a physician, medical policy expert, and public health advocate. As a practicing physician, he was previously a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine. Dr. Gottlieb also has deep FDA experience, having previously served as the FDA’s Deputy Commissioner for Medical and Scientific Affairs and as a senior advisor to the FDA Commissioner.

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August 25, 2017

FDA Considering Removing Regulatory Obstacles to Generic Competition


Mid-July 2017, the United States Food and Drug Administration held a public meeting to discuss options and steps to encourage innovation in drug development and accelerate consumer access to generic drugs. FDA believes that attempting to strike such a balance will speak to Congress’ initial intent when it enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). 

FDA Commissioner Scott Gottlieb opened the meeting with a discussion of the Agency’s position and the announcement of the intended 2017 release of two new documents to improve the generic approval process as part of his Drug Competition Action Plan announced earlier this year.

The first document, a Good ANDA Assessment Manual of Policy and Procedures (MaPP), will be an internal CDER policy to streamline the ANDA review process inside FDA without lowering approval standards. As part of this MaPP, Complete Response Letters will make clear what aspect of the application needs improvement to obtain approval.

The second document is a Good ANDA Submission Practices Guidance, which will point out common recurring deficiencies in ANDA and provide advice on avoiding them in an effort to ensure better higher quality submissions.

During the meeting, several of the participants discussed the effect of patent and exclusivity periods, regulatory review timelines, insurance reimbursement practices, the number of generic competitors and timing of generic entry, and other market forces on the price of branded and generic prescription drugs.

Many presenters focused on specific FDA regulations that disturb ease of generic entry, pay-for-delay settlements, sham litigation, and other activities undertaken by industry participants that some speakers characterized as abusive and anti-competitive. 

Several presenters discussed features of the statutory and regulatory framework that they believe has allowed innovator companies to “evergreen” their products: to extend patent or regulatory exclusivity periods by seeking approval for ostensibly modest product changes. Presenters debated whether certain changes provide patients with additional value and whether agency resources should be allocated to prioritize the review of new therapies over the review of incremental changes to existing products.

Another topic examined was the number and success rate of “blocking” petitions filed by innovator companies. Participants discussed whether innovator companies have used the citizen petition process to delay generic entry by raising objections that are not scientifically valid or do not raise important public health issues. Industry stakeholders defended the petition process as an important vehicle that allows petitioners to raise legitimate scientific issues.

While the FDA spent the day listening to input, panelists acting on behalf of the FDA asked the presenters to provide specific recommendations on changes they feel the agency can implement to encourage innovation and competition, while avoiding unnecessarily spending resources and remaining within the FDA’s regulatory authority. The public docket for comments closes on September 18, 2017.

August 08, 2017

FDA Issues Two Proposed Studies on Disclosures for Advertising


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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