Jill Wechsler
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The re-election of George W. Bush as president and continued Republican control of Congress will shape the healthcare policy
agenda for the coming year. Major initiatives to expand healthcare coverage to the uninsured or reform Medicaid are off the
administration's priority list, but social security and tax reform may provide additional tax incentives for individuals and
small businesses to obtain health coverage and establish health savings accounts.
PHARMACEUTICALS FOR SENIORS
At the same time, rising healthcare costs and prices will draw intense scrutiny from both Republicans and Democrats anxious
to restrain spending at a time of record budget deficits and escalating counterterrorism outlays. This concern may shape new
regulations and policies for implementing the Medicare Modernization Act (MMA). The GOP victory diminishes chances for new
legislation permitting the federal government to directly negotiate drug prices with Medicare pharmacy plans. Policymakers
will be looking for ways to broaden access to new medical technologies without adding to mounting healthcare bills. When implementing
the Medicare pharmacy benefit, officials will take a hard look at drug costs, utilization, and marketing and support efforts
by Medicare drug plans to establish formularies and negotiate discounts. They also will closely examine payments for therapies
administered in doctors' offices and already covered by Medicare.
SCRUTINIZING SAFETY
Charges that FDA has allowed too many unsafe drugs on the market are prompting a re-examination of new-drug approval criteria
and agency oversight of marketed products. Initial concerns about antidepressants causing suicidality in children and that
patients using Merck's Vioxx may have an increased risk of heart attacks have expanded to include a much broader range of
products. At a November Senate hearing, FDA Safety Officer David Graham cited serious safety issues with Astra Zeneca's cholesterol
agent Crestor, GlaxoSmithKline's asthma therapy Serevent, Pfizer's COX-2 inhibitor Bextra, Abbott's weight loss drug Meridia,
and Roche's acne treatment Accutane. At the same time, adverse event reports prompted FDA to stiffen warnings concerning pregnant
women taking Accutane and proper use of the abortefeceant Mifeprex (mifepristone or RU-486).
These events generated calls for an independent drug safety office — although FDA officials counter that the Vioxx withdrawal
and label changes demonstrate that the agency's post-marketing safety system is working well. Steven Galson, acting CDER director,
noted that FDA's Office of Drug Safety already is independent of CDER's Office of New Drugs and termed Graham's charges "hysterical"
and "baseless."
FDA has commissioned an Institute of Medicine (IOM) study on the effectiveness of its post-market system and the adequacy
of its authority to regulate unsafe products. Critics consider the IOM analysis a waste of time, but it provides an opportunity
to examine these issues more thoroughly and objectively. In addition, FDA has promised to publish final versions of three
risk management guidances that were issued in May, to hold more public meetings to discuss complex drug safety issues, and
to establish a formal program to review conflicting opinions of staff scientists. These actions may help, but Congressional
committees are continuing investigations and planning more hearings.
MULTIPLE CHALLENGES
In addition to drug pricing, access, and safety, manufacturers will face a broad range of related issues in coming months.
Vaccine shortages. The surprise shutdown of Chiron's Liverpool vaccine manufacturing facility in October and the resulting shortage of flu
vaccine for this winter continues to focus public attention on vaccine manufacturing and oversight. Members of Congress are
blaming FDA for failing to enforce manufacturing standards or recognize earlier the severity of the problems at Chiron's plant.
The situation is raising questions about the adequacy of FDA's foreign plant inspection program and its enforcement approach.
Chiron must show in January that it can correct its manufacturing problems and regain its license in order to produce flu
vaccine for next year. Failure to do so will ignite further calls for policies to encourage manufacturers to enter the US
market. Policy makers will examine the viability of tax incentives for plant construction, a universal flu vaccination policy
to broaden the market, increased support for research on new vaccine manufacturing methods, government guarantees to buy back
unused vaccine doses, and legislation to mitigate vaccine and drug manufacturers liability.
