Jill Wechsler

Jill Wechsler is a veteran reporter specializing in federal health care and pharmaceutical issues.

FDA is struggling to implement a host of new drug safety policies and programs and still meet review time frames set by the Prescription Drug User Fee program (PDUFA).

FDA officials are taking steps to erase the charges of incompetency and ineffectiveness that have plagued the agency for several years.

Even before the emergence of the swine flu pandemic, biopharmaceutical companies were investing in vaccines and treatments for lethal diseases that plague much of the world. There is growing recognition that Americans and Europeans are vulnerable to infections from overseas, and that development of new medications is critical to ensuring public health.

With healthcare-reform legislation moving forward, insurers, providers, and pharmaceutical companies are keeping a sharp eye on policy proposals likely to affect coverage, costs, and benefits. Various constituencies in the healthcare community are supporting initiatives that will increase access to healthcare and make the nation's costly healthcare system more efficient and effective.

An important component in protecting public health, according to Margaret Hamburg, new commissioner of FDA, is to ensure access to innovative, safe, and effective medical products.

FDA is stepping up oversight and enforcement activity for medical products as part of its efforts to demonstrate a vigorous approach to ensuring food and drug safety.

The economic stimulus package approved by Congress in February provides more than $1 billion to support research on competing medical treatments. Although a fairly minor piece of the larger $789 billion American Recovery and Reinvestment Act of 2009 (ARRA), the provision set off widespread reaction to the possibility that comparative study results may be used to limit coverage of more expensive medicines.

The headlines about contaminated heparin and tainted peanuts have put pressure on FDA to improve its methods for detecting unsafe medical and food products and to take swift action when problems emerge. The complaints are prompting the Obama administration to provide more resources for FDA while Congress weighs expanding agency operations and enforcement authority.

A prominent theme in health-reform efforts is the need for more transparent information about healthcare cost and quality upon which providers and patients can base their treatment decisions. Many federal agencies and state governments are expanding their requirements for pharmaceutical companies to report payments made to researchers and physicians, and for health plans to give beneficiaries more information on drug costs and coverage.