Pharmaceutical Commerce - January/February 2011 - (Page Cover1)

Business Strategies for Pharma/Bio Success www.PharmaceuticalCommerce.com JANUARY/FEBRUARY 2011 Legal | Regulatory Brand Marketing & Communications Adverse Event Reporting: At the Front Lines of Drug Safety Industry and regulators are taking steps to revolutionize the basic regulatory function of collecting and analyzing adverse medical events By Nick Basta OTC and Retail Purchases Round out the View of Patient Behavior Combining prescription and OTC purchasing patterns gives deeper insights into patient behavior By Melissa Leonhauser, SDI The metaphor of changing an airplane’s engine while in flight comes to mind when looking at the current landscape of pharmacovigilance and the adverse event report (AER) process. The system is widely acknowledged to have serious flaws, especially in underreporting events; there is disagreement over how AERs should be analyzed, and difficulties at FDA in simply keeping up with their flow; and there are there are dramatically new approaches in the offing, but adopting them broadly will take some heavy lifting. Meanwhile, per longstanding regulatory mandate, every manufacturer (and repackagers and distributors as well, to get technical about it) is required to collect and codify AERs as they come in from healthcare providers, patients and caregivers, and report them to FDA on a schedule. The volume of AERs is now approaching 700,000 annually in the US (Fig. 1)—which is somewhat paradoxical because more AERs are generated early in new drug’s commercial existence, and the number of new drugs has been flat for several years now. More importantly, the number of serious adverse events—those that cause life-threatening conditions or result in permanent impairment—is rising. (Both the growth of AER volume and the serious AEs, though, could be attributed to better data collection and more energetic reporting.) The Vioxx debacle from 2004, when a widely used, heavily promoted pain medication was with- drawn from the market after unforeseen cardiac arrests occurred among patients, continues to drive pharmacovigilance structure. FDA has embarked on ambitious plans—Project Sentinel, the Observational Medical Outcomes Partnership, and FAERS, the FDA Adverse Event Reporting System (an update to its existing AER system). MedWatch, the basic intake system for AERs is in the process of becoming MedWatch-Plus. The FDA Amendments Act of 2007 led to the creation of an FDA Office of Surveillance and Epidemiology (OSE), along with directives for the new research efforts. “Today’s system is a mess,” bluntly states Dr Edward Fotsch, president of PDR Network, a for-profit subsidiary of the iHealth Alliance, which is a united effort among medical societies. “Everyone [we’ve talked to] agreed that the AERS [Adverse Event Reporting System, of which MedWatch is part] is seriously flawed,” stated Dr. Stephen Spielberg, head of an FDA advisory panel, in a presentation to the FDA Science Board in November. “Spontaneous” reports—i.e., the usual reports generated by doctors and patients, not part of a clinical study—“lack critical information” such as the drug manufacturer involved or the gender of the patient. The MedWatch takes too long to fill out, and FDA’s internal system for analyzing data (which often starts with a paper report filing) is cumbercontinued on page 24 > Studying patients’ prescription behavior over time is nothing new; the industry has been utilizing longitudinal patient data for over a decade. But what is new is tracking and combining information about patient behavior beyond prescriptions for a more comprehensive view of patient care. More recent data additions, including medical and hospital claims, lab tests and consumer attributes, improved the understanding of market dynamics and likely influences of patient and practitioner behavior. But this expanded view was still limited, especially in markets where prescription drugs compete with, or are complemented by, over-thecounter (OTC) drugs and consumer packaged goods (CPG). Today, studies can include another component of patient behavior: which what OTC drugs and other goods they are purchasing. This additional insight has expanded the view into how patients—and in some cases their caregivers—are managing their health. continued on page 14 > Business & Finance The Changing Face of Today’s PAPs Once reserved for uninsured, many patient-assistance programs have evolved to meet the needs of the underinsured. On the horizon: the potential effects of healthcare reform law By Suzanne Shelley Established to provide access to critical therapies for patients who cannot afford to pay, and to support the physicians who serve them, charitable patient-assistance programs (PAPs) sponsored by drug manufacturers have become an essential component in the healthcare safety net. Today, the majority of biopharmaceutical companies offer PAPs for most of the branded products in their portfolios, and physicians have come to expect them. As a general rule of thumb, “Through their PAPs, pharma manufacturers give away drugs whose list price represents a growing percentage of total sales,” says Kevin O’Leary, senior principal, pricing & reimbursement for IMS Health (Norwalk, CT). “Typically, the manufacturer’s cost-of-goods is relatively small compared to list prices, and patients enrolled in PAPs do not represent lost sales, because they would not otherwise have been able to purchase the drug.” “Biopharma companies are extremely conservative on how PAPs can and cannot be used to support other brand-marketing activities, and since these programs are designed to serve purely philanthropic continued on page 10 > MENDOTA, IL PERMIT 200 PRSRT STD US POSTAGE PAID http://www.PharmaceuticalCommerce.com

Table of Contents for the Digital Edition of Pharmaceutical Commerce - January/February 2011

Pharmaceutical Commerce - January/February 2011
Contents
Editorial
Op-Ed
Top News
Business | Finance
Brand Marketing | Communications
Supply Chain | Logistics
Information Technology
Manufacturing & Packaging
Legal | Regulatory
Executive Training & Development
Meetings & Editorial Index

Pharmaceutical Commerce - January/February 2011

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