Jill Wechsler, Pharm Exec’s Washington Correspondent

Tax and budget decisions will shape the healthcare market and drug research and regulation.

Recent change likely to boost drug coverage by plans, but with variation in formularies.

While the nation was embroiled in the presidential elections, a number of important legal and regulatory issues absorbed pharmaceutical executives, writes Jill Wechsler.

The prospect that antiretroviral drugs could prevent HIV infection in high-risk populations was the big news emerging from last month’s International AIDS Conference in Washington, DC.

The time and cost of developing new drugs are rising, venture capitalists make no return on investments in biopharma R&D, and other countries are boosting support in this area while U.S. policy makers propose funding cuts for the National Institutes of Health (NIH).

Comparative research documenting value and affordability is key to obtaining coverage for high-cost therapies. Jill Wechsler reports.

It’s back to business for pharma and biotech companies. The main result of the Supreme Court decision upholding the Affordable Care Act (ACA) is that it ends all the rampant speculation and uncertainty about the future shape of the U.S. healthcare system.

Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs.

A rash of "pro-innovative" approaches for testing and regulating medical products offer ways to speed more new products to market.

Legislation to reauthorize Food and Drug Administration user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure.

Switching Rx drugs to OTC and adding comparative data could broaden access to treatment, writes Jill Wechsler.

Disclosure rules the day, as industry confronts demands to report supply problems, results of clinical trials, and payment to doctors.

FDA and industry are pushing user fees, while they struggle with curbs on communications.

Will expanded markets and ACOs offset higher rebates, added fees, and closer scrutiny of marketing and prices?

Look for action in 2012 on drug access, shortages, innovation, and transparency.

Agency expansion and globalization promote innovation, collaboration, and organizational changes

Clamor for critical therapies prompts probes of prices, production practices.

Marck McClellan, MD, Director, Engelberg Center for Health Reform, Brookings Institute

Henry Waxman, Congressional Representative from Los Angeles, California

Francis Collins, MD, PhD, Director, National Institutes of Health

Sidney Wolfe, MD, Director, Public Citizen's Health Research Group

Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research

User-fee renewal legislation sets the stage for new policies affecting reimbursement, research, and regulatory oversight.

A number of important decisions from the Supreme Court will affect drug marketing, research, and regulation

Sponsors must handle interchangeability, exclusivity, cost and coverage hurdles to win biosimilars game

FDA's opiod REMS implies there is still value in industry-sponsored CME

Stiff price tags draw scrutiny from Congress and consumers, and raise questions about FDA policies

Courts, Congress review policies and programs shaping drug costs and access

FDA's Sentinel Initiative raises broader questions about tapping patient information and health IT for comparative studies in drug development

With Francis Collins now calling the shots at NIH, will be be able to deliver on the innovations behind the genome?