Jill Wechsler, Pharm Exec’s Washington Correspondent

FDA commissioner Margaret Hamburg has formed a top-level working group to propose strategies for enhancing agency functions and processes, starting with the relationship between FDA Centers and its field force.

The blurring of advertising and editorial content, particularly through publishers’ websites and mobile applications, is in the spotlight at the Federal Trade Commission (FTC) as government regulators struggle to deal with the impact of social media on health-related promotion.

Rising costs will mean a drop in anticipated NDAs next year, reflecting an ever-longer and more costly drug-development process that is squeezing pharma investment in R&D.

We’re already embroiled in the annual speculation game about whether FDA approvals this year will keep pace with last year’s near-record of 39 new molecular entities (NMEs) brought to market

Rate cuts and fraud concerns create problems for Part D plans and Part B providers.

What was once an obscure federal policy for providing low-cost drugs to safety-net hospitals has grown into a program that requires extensive discounting to one-third of the nation’s hospitals and health clinics. Pharma companies are pushing back, heightening tensions between “covered entities” that qualify for greatly reduced prices on medicines under 340B - and manufacturers that see the discounts making a big dent in U.S. revenues.

FDA wants pharma leaders to do more to ensure drug quality at home and abroad. Our Washington correspondent Jill Wechsler reports.

Pharmaceutical companies can anticipate more costly, drawn-out patent litigation in the wake of the June 17 US Supreme Court decision, which creates great uncertainty about the grounds for negotiating settlements in patent cases.

The Supreme Court decision blocking patents on naturally-occurring genes has generated predictions of doom for biotech innovation, along with expectations of more healthy competition in discovering new treatments and diagnostics. Although some commentators regarded the decision, Association for Molecular Pathology v. Myriad Genetics, as a “major reversal” in longstanding patent policy, many leaders of the biopharmaceutical research community described the ruling as likely to spur innovation and the development of therapies and companion diagnostics necessary for advances in personalized medicine.

New approaches for conducting clinical trials and developing therapies that actually prevent and cure disease are key to the future of effective drug therapy, according to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER).

Opioid abuse generates calls for efforts to curb distribution, develop abuse-resistant formulations.

Legal battles and regulatory missteps undermine access to low-cost generics, at home and abroad, writes Jill Wechsler.

Just about every federal program and affected interest group is pressing for relief from the 8% across-the-board cuts in funding imposed by the budget sequestration mandate. Recent fast action on Capitol Hill to curb personnel furloughs of air traffic controllers by the Federal Aviation Administration, though, has spurred lobbying for similar treatment across many fronts.

The new National Patient-Centered Clinical Research Network funded by the Patient-Centered Outcomes Research Institute (PCORI) aims to provide patients and clinicians with useful information on treatment options and outcomes

The Food and Drug Administration has come down on the side of reducing abuse of opoid medications, over encouraging wider availability of low-cost painkiller meds.

The Obama administration’s budget plan for fiscal year 2014 apparently assumes that the pharmaceutical industry can support Medicare and other health programs through changes in drug coverage and payments.

There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices.

There seems no end to demands for data on clinical research, conflicts of interest, company payments, and drug prices.

After less than a year on the job, the head of FDA’s Office of Generic Drugs (OGD) has announced his departure, a sign that all is not well with plans for major organizational changes at the Center for Drug Evaluation and Research (CDER).

The greatly feared federal budget sequestration mandate went into effect March 1, and, initially, the impact was fairly muted.

Pressure for action on key enforcement and regulatory issues may prompt congressional action this year.

While health care was barely mentioned in the recent State of the Union address, President Obama generated some interest in his proposal to cut Medicare spending by reducing “taxpayer subsidies to prescription drug companies.”

A new report from the Institute of Medicine (IOM) has drawn a lot of attention to the public health dangers of falsified and substandard medicines around the world.

More new medicines gained market approval in 2012, but marketers face resistance from payers looking to cut healthcare spending, writes Jill Wechsler.

The much-discussed US v. Caronia case, which has raised questions about the Food and Drug Administration prosecution of pharma companies for making off-label product claims, doesn’t change very much, according to FDA’s top drug marketing enforcer.

In the dog-eat-dog world of federal deficit reduction, there seems to be one health-related spending cut with broad bi-partisan support: require drug companies to give the federal government “a better deal on medications for low-income people on Medicare.”

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies.

FDA policies will reshape drug development, while pressure to cut healthcare spending may alter drug coverage and pricing.

If people can promote drugs for uses that lack supporting evidence, it would turn back the clock to the pre-1962 world of medicine where there wasn’t any research or data on what medicines worked and what was harmful, says Robert Temple, deputy director for clinical science at FDA’s Center for Drug Evaluation and Research (CDER).