FDA Struggles with Risk Management and Drug Safety - Pharmaceutical Technology

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FDA Struggles with Risk Management and Drug Safety
Weighing the pros and cons of REMS for bringing risky products to market.


Pharmaceutical Technology
Volume 34, Issue 9, pp. 26-32

Seeking remedies

The solutions to these problems are not obvious. Industry agrees with providers that multiple REMS programs impose added recordkeeping and compliance requirements and threaten to delay patient access to needed therapy. But although some stakeholders seek more standardization and uniformity in REMS plans to minimize new educational programs, manufacturers generally fear that a one-size-fits-all approach will not work. They argue that there are too many diverse products with various indications for different patient groups.

Pharmaceutical companies would like FDA to play a larger role in explaining to providers the need for educational and distribution requirements, said Jeffrey Francer, assistant general counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) at the public FDA meeting. He proposed that FDA spell out in action letters on new drugs why a REMS is needed, what risks are being addressed, and why other risk-management tools are insufficient to protect patients. CDER's Office of Surveillance and Epidemiology, moreover, should conduct "systematic outreach to patient and provider groups" to explain how the agency weighs the benefits of a REMS against the added burdens imposed on patients and providers, he said.

PhRMA's main proposal, Francer added, is to simplify MedGuide production and oversight by separating this activity from the REMS program, as it was before the enactment of FDAAA in 2007. Then, MedGuides were considered part of labeling, and not related to specific risk-management plans. Now, as part of the REMS program, manufacturers also have to establish program goals, monitor how well pharmacists and providers distribute the information, and develop timetables for assessing the plans. The extra requirements generate a lot of paperwork for both industry and FDA that does not necessarily improve patient care.

Providers complain of excess MedGuides for patients to review, often repeatedly. Kidney-dialysis patients, for example, have to examine the same risk information at every monthly treatment session, a requirement that physicians find burdensome and ineffective. Woodcock acknowledged that paper MedGuides are not the optimal way to provide patients with information and said that FDA plans to develop a patient-information leaflet using modern communication science. Several stakeholders support that approach and the development of templates or standardized formats for MedGuides to reduce confusion for providers and for patients. However, pulling MedGuides out of REMS would require Congressional action, as would an FDA effort to establish a single document for describing drug risks and benefits.

Another industry goal is to streamline the process for modifying established REMS by reducing the number of changes that require prior approval. The current policy creates unnecessary delays and wastes FDA resources, said Andrew Emmett, director for science and regulatory affairs at the Biotechnology Industry Organization. He proposed a tiered approach to REMS modifications that would allow sponsors to merely notify FDA of administrative and technical changes and limit prior approval to those revisions that affect the main goals, timetable, or implementation system of a REMS.

Although manufacturers welcome support from providers for curbing the scope and number of REMS, they are leery about third parties playing a more prominent role in REMS development and approval, something that pharmacists, physicians, and health plans are demanding. At the public meeting, providers called for a more transparent REMS development process so that they will be aware of upcoming risk-management programs and have an opportunity to weigh in early on specific proposals. Steven Russek, vice-president and chief clinical officer of Medco's Accredo Health Group, observed that drug manufacturers informally seek advice on what works in risk management, but then go back to negotiate with FDA. "Then it's silent," he said, "and then a REMS pops up."

It's not clear how or when FDA could consult third parties on REMS proposals. Before approving a drug for market, confidentiality restrictions prevent the agency from indicating that a REMS is under discussion, explained Jane Axelrad, director of CDER's Office of Regulatory Policy. "How can we meet early with sponsors to discuss REMS to avoid delay," queried John Jenkins, director of CDER's Office of New Drugs, when "consumers see early agreement on REMS lacking in transparency?"


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