Jill Wechsler, Pharm Exec’s Washington Correspondent

FDA doesn't usually write a black box warning "without some pretty good data," said Robert Temple of FDA's Office of Medical Policy. Overuse of the black box can both dilute its impact and limit access to needed treatment.

Pharmaceutical companies are worried that FDA's new labeling format will expose them to liability suits from individuals who suffer adverse events that are not highlighted, but "hidden" in the full prescribing information.

While CMS officials praise the CED policy as a way to extend Medicare coverage, patients and industry fear the agency won't reimburse for innovative treatments unless sponsors support post-approval studies.

To Janet Woodcock, Critical Path hasn't been dying, it's been getting work done."People shouldn't underestimate the difficulties of creating new models. A lot of things worth doing can't happen quickly."

FDA wants flexibility to use user-fee revenues to extend drug safety oversight, to review direct-to-consumer advertising before it goes public, and to modernize the ever longer and more complex drug development process.

FDA may be receiving fewer new drug applications for truly innovative products, but it has been overwhelmed this year with 800 abbreviated NDAs for generic drugs and thousands of supplements.

The circumstances of Crawford's departure may complicate the process of securing a permanent FDA leader. Congress and HHS are investigating whether his confirmation process failed to uncover important facts.

Many still regard FDA's approach as costly and unnecessary. But the prospect of qualifying for purchase by PEPFAR is attracting applicants. The policy has helped bring news AIDS treatments to market.

Hours after Lester Crawford resigns, the head of the National Cancer Institute takes his place on the FDA hot seat.

FDA could lose 251 employees under the administration's proposed 2006 budget. The agency will try to do more with less through risk-management practices, but important tasks will fall by the wayside.

Integra v. Merck KGaA supports research by large pharmaceutical companies, but it also opens the door to greater use of compounded materials by all parties. Congress may have to clarify its scope.

Pharma companies believe that they can compete in an e-prescribing environment if information systems permit full disclosure and allow doctors to create bookmarks that link easily to information they want.

CMS envisions studies to show which drugs keep patients out of hospitals or how certain treatments can reduce side effects. Such analysis would support decisions on best practices in using medications.

Just a decade ago, FDA was accused of dragging its feet on new drug applications. Now, supposedly, the agency is moving so fast that it's letting unsafe, insufficiently tested products into the marketplace.

Reformers want to give FDA more clout, but agency officials say internal changes will help fix drug safety problems.

Should policy makers expect 90 percent of seniors to enroll in PDPs, or will 75 percent be enough? Will the program have to keep costs down to $400 billion a year, or will spending be linked to savings elsewhere?

One response to today's safety concerns is particularly alarming: The research community has become skittish about conducting clinical studies involving pain medications and other high-risk treatments.

Expanded coverage for the uninsured and Medicaid reform are low priorities at the White House.

Finger pointing has begun in earnest, as Congress tries to decide who ignored what warning, who silenced what staff scientist, and who broke what law. But recent events also raise real long-term issues for industry.

Waxman promised to put teeth in the proposal by levying fines on sponsors of clinical trials that fail to comply.

Tremendous changes are underway at FDA headquarters in Rockville, Maryland. Whole sections of biologics review moving from one center to another. Regulatory activities being refocused on risk. Restructured roles for agency field inspectors. And a variety of other reforms, many driven by the specter of bioterror. Despite operating for almost two years without a commissioner, FDA is moving full speed ahead with a major reorganization and a new regulatory philosophy.

After months of speculation, in September the White House finally nominated its lead health policy advisor, Mark McClellan, as the next FDA commissioner. McClellan is a physician and economist and, most recently, a member of the White House Council of Economic Advisors. As an MD with no direct ties to the pharmaceutical industry, he fits the basic criteria set for confirmation by the Democratic-controlled Senate.

Multi-tier formularies that set higher co-pays for the most expensive pharmaceuticals reduce beneficiaries' overall spending on prescriptions.

FDA's September announcement that it plans to transfer some therapeutic biologic review functions from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER) caught most agency officials and Washington observers by surprise.

Consumers who lack pharmacy benefit coverage are more likely to ask physicians about the cost of treatments than those who have coverage, according to data from FDA research on the impact of direct-to-consumer advertising.

In an effort to cope with soaring healthcare costs, more employers are establishing three-tier prescription drug benefit plans for workers.

Acting on the belief that states should respect agency rulings involving labeling and advertising, FDA filed legal briefs challenging judges that second-guess its authority.

If policy makers crafting a Medicare pharmacy benefit are worried about heavy prescription spending by seniors, they should take a closer look at medication use by the five million disabled beneficiaries in the program of 40 million patients.

The Senate's failure to approve a Medicare pharmacy benefit in August was not a big surprise on Capitol Hill, but it was disappointing to policy makers on all sides. Instead, the legislators adopted measures designed to make pharmaceuticals more affordable for all consumers.

Instead of developing innovative therapies, pharma companies devote most of their resources to modifying existing medications, according to a report from the National Institute for Health Care Management Foundation (NIHCM).