OUTREACH AND OVERSIGHT
Pharmaceutical and biotechnology companies would like the FDA to shoulder more responsibility for explaining the need for
educational and distribution requirements to providers. The Pharmaceutical Research and Manufacturers of American (PhRMA)
proposes that the 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.
Another industry goal is to streamline the process for making modifications in established REMS by reducing those changes
that require prior approval. The policy creates unnecessary delays and wastes FDA resources, said Andrew Emmett of the Biotechnology
Industry Organization (BIO). 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.
A main change sought by manufacturers is to separate MedGuides from the REMS program. Before FDAAA was enacted in 2007, MedGuides
were considered part of labeling, and not related to specific risk management plans. Manufacturers preparing MedGuides now
also have to establish program goals, monitor how well pharmacists and providers distribute the information, and develop timetables
for assessing the plans. There's a lot of paperwork for both the industry and the FDA. Pharmacists say there are too many
different MedGuides for patients, sometimes different ones on the same drug for pharmacists and physicians. In some situations,
such as with kidney dialysis, patients have to review the same risk information at every monthly treatment session, a requirement
that physicians find burdensome and ineffective. But pulling MedGuides out of REMS requires legislation, as would a move by
the FDA to establish a single document for describing drug benefits and risks.
Woodcock acknowledged that paper MedGuides are not the optimal way to provide patients with information and said that the
FDA plans to develop a patient information leaflet that is more informative and uses modern communication science. A number
of stakeholders support that approach, urging the FDA to devise templates or standardized formats for MedGuides to reduce
provider and patient confusion, and to better focus on the information that patients really need.
AT THE TABLE
Although manufacturers welcome provider support for curbing the scope and number of REMS, they are leery about third parties
playing a more prominent role in REMS development and approval, a main goal of pharmacists, physicians, and health plans.
At the public meeting, providers called for a more transparent process for REMS development so that doctors and pharmacists
would be aware of upcoming risk management programs and have an opportunity to weigh in early on specific proposals.
It's not clear, though, how or when the FDA could consult third parties on REMS proposals. Before approving a drug for market,
confidentiality restrictions prevent the FDA from indicating that a REMS is even under discussion, explained Jane Axelrad
of CDER. John Jenkins, director of CDER's Office of New Drugs (OND) queried: "How can we meet early with sponsors to discuss
REMS and avoid delay, when consumers see early agreement on REMS lacking in transparency?"
An added issue is whether REMS programs erect barriers to generic drug development and follow-on biologics. There is general
agreement that generic and innovator products should use a shared risk management system to avoid unnecessary multiple approaches,
but achieving that goal raises issues about who controls the risk program and how costs should be shared.
FDAAA specifies that a REMS should not block generics from coming to market and includes provisions providing considerable
relief for generics makers in REMS implementation. But generics makers complain that limited distribution systems required
by highly restrictive REMS programs prevent innovators from releasing products for bioequivalence testing needed to develop
generic versions of the drug. Health plans and payers fear similar problems for developers of follow-on biologics, which generally
involve more risky therapies that will be subject to more restrictive REMS requirements.
Jill Wechsler is BioPharm International's Washington editor, Chevy Chase, MD, 301.656.4634,