Jill Wechsler, Pharm Exec’s Washington Correspondent

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.