Regulatory Beat: Policy Makers will Focus on Drug Safety and Costs in 2005 - Concerns about inadequate attention to product quality and adverse events may slow R&D. - BioPharm International

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Regulatory Beat: Policy Makers will Focus on Drug Safety and Costs in 2005
Concerns about inadequate attention to product quality and adverse events may slow R&D.


BioPharm International



Jill Wechsler
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.


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