Life Science Compliance Update

December 18, 2017

FDA Issues Two Federal Register Notices on Prescription Drug Promotion


On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding prescription drug promotion from the FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP).

Final Guidance on Promotional Labeling

The first notice announces the FDA’s Final Guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisement for prescription drugs (human and animal), including prescription biological products. The FDA believes that the disclosure of the product name in promotional materials is important for the proper identification of the products to help ensure they are used safely and effectively.

The recommendations in this guidance relate to product names in traditional print media promotional labeling and advertisements such as journal ads, detail aids, brochures; audiovisual promotional labeling, such as videos shown in a health care provider’s office; broadcast advertisements (e.g., television advertisements, radio advertisements); and electronic and computer-based promotions such as internet, social media, emails, CD-ROMs, DVDs). In this guidance, FDA further clarifies issues relating to the direct conjunction of the proprietary and established names, as well as the frequency of use of the established name on printed pages or spreads, in running text or columns, in the audio portion of audiovisual promotions, and in electronic media.

FDA recommends that the established name be placed either directly to the right of or directly below the proprietary name. FDA also recommends that the proprietary name and the established name not be separated by placement of intervening matter that would in any way de-emphasize the established name of the product or obscure the relationship between the proprietary name and the established name.

When it comes to the prominence of the proprietary and established names of a product with one active ingredient, the regulations require that “the established name shall have a prominence commensurate with the prominence with which such proprietary name or designation appears, considering all pertinent factors, including typography, layout, contrast, and other printing features.” Generally, FDA considers all methods used to achieve prominence in promotional labeling or advertisements when evaluating whether the established name is presented with a prominence commensurate with that of the proprietary name.

Additional regulations and guidance can be found in the document, including recommendations for products with two or more active ingredients.

FDA’s Proposed Project on Deceptive Presentations

The second notice is related to an FDA proposal to study the ability of consumers and healthcare professionals to spot and report deceptive prescription drug promotion practices. The ability to spot deceptive prescription drug promotion in the marketplace has important public health implications. Patients may use information from drug promotions, such as information about a product’s efficacy and risks, when exploring treatment options and making treatment choices. Likewise, health care professionals may consider information from promotional materials when making prescribing decisions. In cases where such information is false or misleading, consumers may ask for and health care professionals may prescribe specific drugs that they would not otherwise request or prescribe, respectively.

The studies will be conducted concurrently and will focus on different health conditions. Each study will be administered to two separate populations (i.e., HCPs and consumers affected by the condition). HCPs will view mock pharmaceutical websites targeted toward physicians and 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. A professional firm will create all mock websites such that they are generally indistinguishable from currently available prescription drug websites.

Study 1 will sample consumers who self-report chronic pain that has lasted at least 3 months and HCPs whose primary medical specialty is either primary care or internal medicine and whose responsibilities involve direct patient care at least 50 percent of the time. Study 2 will sample consumers who self-report obesity, defined as body mass index greater than or equal to 30 and include the same types of HCPs as study 1.

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, the first study will focus on the degree of deception in an ad while the second study will focus on implied versus explicitly deceptive claims.

Any comments should be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to All comments should be identified with the OMB control number 0910-New and title “Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.” Also include the FDA docket number: FDA-2016-N-4487.

December 15, 2017

PhRMA Releases Report on Financial Flow in Pharmaceutical Industry


In late November, the Pharmaceutical Research and Manufacturers Association (PhRMA) released a new report examining how money flows through the supply chain and how that impacts what patients pay at the pharmacy. According to the report, this system often creates incentives for pharmacy benefit managers (PBMs) to opt for medicines with higher list prices and higher rebates.

The report provides illustrative examples for three patients to not only provide answers, but also to highlight the fact that there is no one price for medicine. This is because prices paid by wholesalers, pharmacies, pharmacy benefit managers (PBMs), and health plan sponsors all vary and are determined by negotiations between stakeholders.

Many manufacturers are offering larger rebates on medicines every year. However, patients - facing larger deductibles and higher coinsurances than ever before - are increasingly facing cost-sharing that is based on the full undiscounted price. As the examples in the report show, patients often do not benefit from discounts and rebates negotiated between manufacturers and payers and may end up paying more than their insurer for their medicine. Such an arrangement leads to the insurer making money off of the patient’s prescriptions.

The report also notes that as the market moves in the direction of a system that better aligns the price of prescription medicines with their value, biopharmaceutical companies are working with private health insurers to implement new payment arrangements for a variety of diseases. In addition, biopharmaceutical companies and health plans are considering new ways to pay for treatment when a patient needs multiple high-priced, innovative medicines and experimenting with money-back guarantees if a medicine does not work as intended. These new types of arrangements offer the potential to increase the choice of therapy, ensure that patients have affordable access to the newest medicines, and enable our health care system to achieve better outcomes at even more affordable prices

By reading and understanding this report, patients and policymakers alike may find answers to their questions and concerns about the affordability of, and access to, medicines. While many things today are politicized and your opinion depends on your political affiliation, one thing most Americans can agree on is that patients should benefit more from negotiated rates in the form of lower out-of-pocket costs at the pharmacy, just like they do for other types of health care services.

December 13, 2017

FDA Issues Guidance on Real-World Evidence for Medical Devices


Earlier this year, the United States Food and Drug Administration (FDA) finalized guidance on the use of real world evidence to support regulatory decision-making for medical devices. The final guidance follows a July 2016 draft guidance on the topic in which the FDA discussed potential uses of real world data and the various factors evaluated to determine whether that data can support a regulatory decision. The FDA believes that this guidance is a “cornerstone” of its strategic priority to build a national evaluation system for health technology.

The final guidance includes clarity as to what it means for companies moving forward, “While FDA encourages the use of relevant and reliable real-world data, this guidance neither mandates its use nor restricts other means of providing evidence to support regulatory decision-making.”

In the final guidance, FDA recognizes that “traditional” clinical trials may sometimes be impractical or overly challenging, and appropriate real world data can sometimes provide comparable information. While clinical trials are controlled and require monitoring and data auditing, they may be narrow in scope. Real world data may be able to generate information on a broader patient population, but studies must be carefully designed, regardless of whether the real world data has already been collected or will be collected in the future. Protocols and analysis plans for real world data “should address the same elements that a traditional clinical trial protocol and statistical analysis plan would cover.”

The final guidance also notes that due to the “rapidly advancing methodology for generating and interpreting real world data, this guidance will not elaborate on the methodological approaches that can be used.”

The FDA believes that real world data drawn from clinical practice settings can provide greater insight into the benefits and risks of medical devices, including how they’re used by health care providers and patients, and how they perform under the conditions of routine medical practice. The guidance does not change the evidentiary standards that are required to make those decisions.

Given the expansion in the availability and use of health data derived from registries, billing claims, and electronic health records, the FDA is taking these steps in hopes of clearly describing the appropriate characteristics of real world evidence that meet the agency's standards of evidence to support regulatory decisions.

To assess reliability of data, the FDA is primarily concerned with how the data were collected (data accrual), and whether there were people and processes in place to provide “adequate assurance” that the data quality and integrity are sufficient. The real world data source should have an operational manual (or similar document) in place specifying the methods and extent of data collection and aggregation. FDA provides a list of factors that it will consider the when assessing data accrual, many of which are also considerations for any clinical trial.

Several weeks after the release of the guidance, FDA Commissioner Scott Gottlieb stated that the agency will need to work with the healthcare system to change the way clinical information is collected.

"We need to close the evidence gap between the information we use to make FDA's decisions and the evidence increasingly used by the medical community, by payers, and by others charged with making healthcare decisions," Gottlieb told attendees of the National Academy of Sciences' workshop on the impact of real world evidence on medical product development.

While noting the current uncertainty among sponsors on the role real world evidence plays in regulatory decision making, Gottlieb said FDA needs to think of itself as an information curator, rather than an arbiter of information, "where a single truth standard is secured to a fixed orthodoxy."

Rachel Sherman, principal deputy commissioner at FDA, added later in the day, "We want a better evidence base to make product approval decisions" and she noted that more guidance will be forthcoming on real world evidence and real world data. "The goal is not to define real world evidence and real world data but to get better information and in a more sensible way," she added.

For more information, we encourage you to read the final guidance and access the FDA webinar on the topic here.


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