Jill Wechsler, Pharm Exec’s Washington Correspondent

A number of top management positions at the Center for Drug Evaluation and Research (CDER) need to be filled.

As payers demand more evidence documenting medical product value, biopharma companies are responding by moving sooner to decide key clinical outcomes to measure.

Accelerated testing and production create challenges in documenting product quality, writes Jill Wechsler.

The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy and clinical utility of companion diagnostic tests.

While biopharmaceutical companies are using websites and third-party postings to provide information on medical products - despite a host of regulatory issues - social media use is in its infancy related to the design and conduct of clinical trials.

In an abrupt about-face, the Obama administration halted its ill-timed effort to launch an overhaul of the Medicare Part D program and announced it would not pursue changes in some key rules as proposed earlier this year.

Despite a slight boost in funding for the Food and Drug Administration and stronger tax incentives for investment in R&D, significant changes in Medicare drug reimbursement and coverage policies have biopharmaceutical companies up in arms.

Despite recent legislation to establish a more secure pharmaceutical supply chain to deliver high quality, approved medicines to American patients, efforts to block the import of substandard, fraudulent, and counterfeit drugs remains an uphill fight.

Transparency initiatives are multiplying, affecting research, marketing and compliance.

The growing clamor for broader access to information on health care practices, policies and costs is affecting research, marketing and compliance, writes Jill Wechsler.

Despite notable successes in preventing and mitigating short supplies of important medicines, the drug shortage crisis still disrupts medical treatment and gives drug manufacturers a bad name.

The Patient-Centered Outcomes Research Institute (PCORI) is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media.

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance.

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays.

Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging.

As expected, the Food and Drug Administration (FDA) approved only 27 new molecular entities (NMEs) in 2013.

Pricing and personalized medicine are key themes shaping drug development and marketing in the U.S. in 2014, writes Jill Wechsler.

While the struggle continues in 2014 to provide effective and affordable coverage, administration and Congressional leaders will weigh a host of spending options important to coverage and delivery.

Pricing and personalized medicine are key themes shaping drug development and marketing

The bacterial meningitis outbreak at Princeton University in recent weeks has raised questions about why there is no vaccine in US to prevent this deadly disease, when such a therapy is approved in Europe and Australia.

Congress gave final approval this week to new legislation to strengthen Food and Drug Administration authority to oversee large pharmacy compounders of sterile injectibles and to require more comprehensive tracking of prescription drugs moving through the global supply chain.

FDA is proposing to revise its rules to permit generic drug manufacturers to initiate safety labeling changes, and not wait until the brand company takes that action.

Health plans that limit drug converge will encourage consumers to obtain medicines illegally, according to pharmacy experts.

High prices, murky financial relations, and a reluctance to disclose clinical data undermine public trust in industry and the research enterprise.

As insurers, payers, and drug plan operators eye increased generic drug use as key to cutting healthcare costs, pharma companies are ramping up efforts to delay marketing of copycat products.

Officials from the Food and Drug Administration and the National Institutes of Health were scheduled to explain developments in clinical trial registration and transparency at the Drug Information Association’s conference on Clinical Trial Disclosure in Bethesda, Md. this week.

Tension mounts over biosimilars, co-pay coupons, trade, and testing.

Public outrage over deaths from contaminated injectables produced by large compounding pharmacies, along with rising concerns about counterfeit and unauthorized drugs entering the U.S. market, managed to lift the stalemate on Capitol Hill long enough to generate agreement on reform legislation.

Healthcare spending will rise modestly in the US over the next decade, as economic growth picks up, health reform provides expanded coverage, and the population continues to age, according to an annual analysis from the Centers for Medicare and Medicaid Services (CMS).