Leveraging Postapproval Research

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Craig Eslinger

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Only a few short years ago, both product management and product marketing were considered relatively straightforward and uncomplicated activities. Sales representatives were more likely to have greater access to physicians and healthcare providers, and fewer restrictions were placed on marketing activities. “Once a product received regulatory approval, subsequent research activities were generally considered complete, except for activities that looked to expand the product’s indication or indications or to explore new avenues for product delivery,” says Craig Eslinger, global senior executive director, postapproval services, at PPD.

THE PRESENT: REGULATORY CONCERNS

Recently, the postapproval landscape has changed. With the onset of scrutiny from the Office of the Inspector General (OIG), marketing activities, especially those activities in the realm of late stage research, have been severely restricted, and many former marketing strategies are no longer allowed. “Some states are now passing legislation that completely eliminates any or all promotional spending, and sales representatives are finding it nearly impossible to get an audience with their target customers,” he says. “To further complicate matters, recent product withdrawals over the past few years have resulted in negative public sentiment not only toward the pharmaceutical industry, but also aimed at the FDA. These withdrawals have tarnished our industry’s reputation. Congress and the American public are pushing for new and more effective ways to ensure that products on the market are safe and receive continuous scrutiny. The FDA is now under increased pressure to establish premarket safety as well as post marketing safety surveillance, and a number of risk management initiatives are under way to achieve that goal.” Mr. Eslinger cites as an example the FDA’s recently revealed “Safety First — Safe Use,” a new initiative intended to strengthen the agency’s internal processes for managing the safety of drugs on the market. The goal of the initiative is to provide equal consideration and attention to product safety in both the premarketing and postmarketing settings, which will most likely result in an increase in the number and scrutiny of postapproval safety studies. The industry is also under increasing pricing pressures, and as such he says many providers are now requiring costeffectiveness data before allowing any products on formularies. In addition, patient reported outcomes (PRO) — quality of life and related types of information, which are obtained directly from patients — is another area of increasing inter est to researchers and regulatory agencies. Information on PROs can demonstrate a product’s effect on quality of life. “But obtaining information from patients is becoming more difficult as a result of necessary privacy initiatives, such as the Health Insurance Portability and Accountability Act (HIPAA) of 1996,” he says. REGISTRIES CAN ADDRESS REGULATORY CONCERNS Mr. Eslinger avers that scientifically rigorous, well designed, and well executed registries can address regulatory concerns and research agendas as well as help with the above noted obstacles. “As an unintended consequence, registries can build a strong brand, increasing a product and corporation’s public persona,” he says. “But it’s imperative to identify the appropriate observational — epidemiologic — study design to match the regulatory concern or research agenda and to analyze, interpret, and frame registry results in the appropriate scientific context. In addition to information on treatment effectiveness and product safety, observational studies can obtain information on patient reported outcomes to assess a product’s effect on quality of life.” It is widely known that drugs are not 100% safe and that clinical development alone may not provide a comprehensive picture of a product’s safety profile. Side effects can appear at a later date for drugs taken for a long period of time or by very large populations. As a result, postapproval research may be a good complement to clinical development. Mr. Eslinger notes that following the pas sage of the Prescription Drug User Fee Act and its amendment in 2007, the FDA now has the mandate to require sponsors to conduct postapproval studies. Thus, observational studies conducted for what were once considered to be postapproval commitments can now be viewed as postapproval requirements. Craig Eslinger Future marketing and product strategies will need to change for a product to be successful. Postapproval research provides a method to address lagging consumer confidence while also yielding valuable clinical and safety information. CRAIG ESLINGER IS GLOBAL SENIOR EXECUTIVE DIRECTOR, POSTAPPROVAL SERVICES,AT PPD, WILMINGTON,N.C.,A GLOBAL CONTRACT RESEARCH ORGANIZATION PROVIDING DISCOVERY, DEVELOPMENT,AND POSTAPPROVAL SERVICES AS WELL AS COMPOUND PARTNERING PROGRAMS. FOR MORE INFORMATION,VISIT PPDI.COM. Leveraging POSTAPPROVAL Research The postapproval landscape has changed for pharmaceutical manufacturers. Strict regulations now require companies to engage in postmarketing safety surveillance; however,data obtained during this time can be used to a company’s advantage. “The number of registries conducted as postapproval commitments/requirements is expected to increase because of recent legislation and increased public scrutiny and congressional interest related to drug safety,” he predicts. “When used to support product strategy, a well planned, executed, and interpreted registry may have a powerful effect on future product adoption and overall return on investment.” THE OPPORTUNITY “Registries” is an umbrella term representing a number of observational study designs used to address regulatory concerns or research agendas in postapproval, and sometimes preapproval, settings. Mr. Eslinger states that they should only be conducted to answer scientifically valid questions, using methods consistent with the Guidelines for Good Pharma coepidemiology Practices made available by the International Society of Pharmacoepidemiology, based in Bethesda, Md. VIEW on postapproval research “Registries can be used in a number of roles and functions, such as in hypothesis testing, hypothesis generation, risk minimization activities, natural history of disease studies to support clinical development efforts, pregnancy registries, product registries, and longterm safety data collection after drug approval,” he says. “This list is by no means exhaustive, but illustrates the flexibility of observational studies to support indirectly a wide array of product management and product marketing functions.” Research conducted after a product’s approval is different from the controlled environment of research conducted before a regulatory agency’s approval. Before approval, research is focused on the product’s safety and efficacy and is conducted by experienced investigators in a limited patient population. It is guided by strict protocols with stringent inclusion and exclusion criteria. “But once a product is approved, it is then studied in the real world context of normal use under the care of practicing, community based physicians — i.e., physicians not normally involved in day today clinical research,” he says. “The products are used by a broader patient population, which may have other medical conditions and be taking additional medications. This real world evaluation is the next step of the product’s life cycle and needs to be monitored closely for safety signals.” Data collected before approval, immediately after approval, and for the rest of a product’s life cycle are valuable because the information can help create credible strategies that support marketing efforts. Realworld research collects data that physicians, health care providers, and patients can use to assess their treatment management, increase product adherence, and strengthen a product’s place in the market place. These data also will be more credible, because the information has been collected by practicing professionals using a product in their practices. Data collected from these studies can be used to fuel such marketplace activities as:

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