Jill Wechsler, Pharm Exec’s Washington Correspondent

Washington DC-In addition to launching an ad campaign backing adoption of a Medicare drug benefit, PhRMA is expanding its state lobbying efforts to block local prior authorization requirements. As more states face huge shortfalls in Medicaid budgets because of declining revenues and rising healthcare costs, they seek to cut spending on prescriptions. That means more restricted formularies and rebate requirements, with prior authorization imposed on doctors to limit prescribing of therapies that fail to offer sufficiently attractive deals.

After months of stalemate between the White House and Senate democrats over the appointment of a new FDA commissioner, Health and Human Services secretary Tommy Thompson took a shortcut February 26 and named Lester Crawford deputy commissioner. The move allowed Crawford to start work at FDA immediately, skipping the lengthy Senate confirmation process.

Eli Lilly recently joined the growing list of pharma companies offering discount card programs for Medicare beneficiaries in an effort to "do something now" to help low-income seniors afford medicines. Although Lilly chairman Sidney Taurel voiced support for a broader drug benefit for the elderly-as do his pharma colleagues-he described the LillyAnswers program as "quick relief" while the Medicare-reform debate continues.

Washington DC-As part of its continuing investigation into competition and intellectual property rights, the US Federal Trade Commission and the Antitrust Division of the Department of Justice recently kicked off a series of hearings.

Even though FDA officials and company executives maintain that Purdue Pharma hasn't violated any rules governing pharma advertising, critics who want to ban the sale of the painkiller OxyContin complain about the company's promotional excesses. At a hearing before the Senate Health, Education, Labor and Pensions (HELP) Committee in February, patient advocates blamed soaring abuse of the medication on company sales and advertising activities.

The spread of counterfeit products around the world has alarmed companies and international agencies and prompted them to accelerate efforts to address the problem

Healthcare costs and health insurance premiums have soared, and analysts point to double-digit hikes in spending on prescription medicines as a prime culprit. A recent annual survey by the Department of Health and Human Services' (HHS) Centers for Medicare and Medicaid Services (CMS) finds that healthcare spending in 2000 increased 7 percent to $1.3 trillion, the biggest increase in the past decade, outpacing gross domestic product growth. Prescription drug expenditures alone jumped 17 percent, making them the fastest growing service expense for that year. The Kaiser Family Foundation (KFF) also reports that the portion of total healthcare spending devoted to

Washington, DC-A new advisory committee appointed by HHS secretary Tommy Thompson will scrutinize agency policies to identify ways to improve programs and regulations.

The main challenge for pharma companies this year will be to address public concerns about drug prices and access. Although recent bioterrorism fears raised demands for life-saving medicines, the public focus has shifted to the rise in pharmaceutical expenditures and its effect on healthcare costs and on efforts by insurers and government health agencies to limit pharmaceutical coverage.

One reason new medicines are more expensive is that the cost of discovering and producing new therapies is soaring.

The wrangling over whether pharma companies invest more in R&D than in marketing is heating up again.

If you support the pharmaceutical industry, you will applaud Alan Holmer and the Pharmaceutical Research and Manufacturers of America he presides over. You might disagree with some of the details. But mud you will not sling, nor buy every critic's case against this protector of the industry.

Washington, DC-With no signs that FDA plans to significantly limit direct-to-consumer advertising of prescription medicines, state governments across the country are proposing their own curbs. During the past year, legislators considered some 60 bills or resolutions concerning pharma marketing or advertising, and efforts are likely to increase as state policy makers link DTC advertising to rising drug expenditures.

Washington, DC-Pharma companies suffered a significant setback last month when developing countries at the World Trade Organization meeting pushed through a declaration allowing nations to override patent laws to cope with health crises. Although industry officials insisted that the agreement would have little impact on profits, the language sets the stage for more competition from cheap generic products in much of the world.

Washington, DC-To improve FDA's ability to respond to terrorist attacks, acting commissioner Bernard Schwetz tapped Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), to establish a formal crisis management program for the agency. Woodcock moved to the commissioner's office in November to develop a program to better track and coordinate FDA responses to terrorism.

Government efforts to trim budgets has put the spotlight on unethical pharma marketing tactics.

Government and industry have shown they can work together to deal with a national disaster.

Efforts to craft a Medicare pharmacy benefit may be sidelined by repercussions from the September attack.

Menlo Park, California-Premiums for employer-sponsored health insurance jumped 11 percent from spring 2000 to spring 2001-the biggest increase since 1992-and payers blame that huge spike on pharmaceutical expenditures.

As policy makers struggle to devise a pharmacy benefit for Medicare patients, pressure mounts to impose spending limits on medications. In turn, consumer activists are challenging industry’s longtime claim that price controls will reduce investment in R&D for life-saving therapies.

Democrats are determined to enact legislation that will ensure patient access to certain services and benefits from managed care plans.

FDA district offices may conduct site investigations to establish baseline information for sampling programs and tracking systems.

Concern that gene and stem-cell research could lead to human cloning has generated proposals for legislative bans, which could block promising research.

FDA proposals for expanding the pediatric study program include tax incentives and }transferable exclusivity.}

Calls for change reflect that generic products are a therapeutic mainstay and that patients and providers want earlier access to inexpensive medicines.

Although the extremely close race for the White House and for control of Congress in November signaled a lack of consensus on national health policy, voters have made it clear they are unhappy about the high cost of medical products. That was one of the few issues to emerge from the political haze, and it promises to shape the debate on numerous health and medical topics. The deadline for reauthorizing the FDA user fee program in 2002 also provides a timeframe for developing new programs and policies affecting a number of critical pharma issues.