Jill Wechsler, Pharm Exec’s Washington Correspondent

Rampant concerns about the affordability of, and access to, new life-saving therapies is widening the debate over how much society should pay for new biomedical discoveries, writes Jill Wechsler.

FDA is under pressure to moderate oversight of pharma advertising and promotion.

FDA commissioner Margaret Hamburg has received praise and plaudits as she exits the Food and Drug Administration this week after six years on the job.

FDA is under pressure to moderate oversight of pharma advertising and promotion, writes Jill Wechsler.

A controversial FDA proposal to alter the process for making changes to approved drug labels has drawn opposition and support in equal measure, writes Jill Wechsler.

Congress, Obama offer strategies to reduce regulatory roadblocks to new breakthroughs.

The Securities and Exchange Commission (SEC) is focusing more on the accuracy and timeliness of biopharma company financial filings, particularly those related to regulatory actions involving FDA, writes Jill Wechsler.

The approval of the first biosimilar for market in the U.S. highlights the importance of further clarification from FDA on key policies related to the development and prescribing of highly similar biologics for patients, writes Jill Wechsler.

Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers, writes Jill Wechsler.

The ongoing battle over drug reimbursement and pricing has raised questions about whether the pharmaceutical industry can continue to rely on high U.S. revenues to fund biopharmaceutical R&D.

Following Commissioner Margaret Hamburg announcement that she is to leave FDA in March, Jill Wechsler looks at her achievements and considers the new candidates for the job.

President Obama has unveiled his $215m “Precision Medicine Initiative” to support the future biomedical research, while calling for a reduction in exclusivity on brand biologics from 12 to 7 years and a curb on "evergreen” patents on certain biologics. Jill Wechsler reports.

FDA officials have been busy rolling out advisories for pharma marketers, and there’s no let-up in sight, writes Jill Wechsler.

Pressure mounts for new drug payment models and greater clarity on economic evidence.

The "discussion draft" for legislation to speed "21st Century Cures" to patients emerged very quietly on Capitol Hill this week. Jill Wechsler reports.

FDA's Office of Hematology and Oncology Products (OHOP) is testing a treamlined review process that could be much faster and less costly for certain therapies. Jill Wechsler reports.

Several vaccine candidates are moving into larger clinical trials, supported by government and industry efforts to address manufacturing and research challenges. Jill Wechsler reports.

Investigators and sponsors of clinical trials will have to make more detailed data available following study completion, according to a new report from an Institute of Medicine (IOM) expert panel.

The main surprise at the Jan. 7, 2015 meeting of FDA’s Oncologic Drugs Advisory Committee was the panel’s strong support for a drug developed under a very different model from most cancer therapies, writes Jill Wechsler.

FDA has scheduled a public meeting in early January to assess and weigh the data on the first U.S. application for a biosimilar therapy.

Foreign governments are enacting anti-fraud legislation as part of broader efforts to crack down on corrupt practices involving pharmaceutical companies and healthcare professionals.

Patient access to critical experimental medicines continues to grab public attention, as states enact “Right-to-Try” laws and Congress eyes establishing a national policy to provide not-yet-approved therapies to terminally ill patients

The development and approval of new vaccines and antivirals to contain and treat the Ebola virus outbreak has become a top priority for the federal government and Congress, as seen in new policies to spur R&D and added funding for these efforts.

The Patient-Centered Outcomes Research Institute (PCORI) is launching a $50 million program to fund research on the comparative effectiveness of various approaches for diagnosing and treating hepatitis C.

The breakthrough drug initiative has accelerated the development and approval of highly effective therapies, enabling important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).

US researchers and regulators continue to support the use of randomized clinical trials to test potential treatments and vaccines to combat the Ebola virus, despite objections that this approach is unethical and unfair to vulnerable populations

The Food and Drug Administration is moving fast to implement the drug compounding provisions of new Drug Quality and Security Act (DQSA), issuing new guidance to spur registration by outsourcing facilities just days after President Obama signed the new bill into law.

The two-year-old initiative to accelerate the development and approval of highly effective drugs and biologics has enabled a number of important new medicines to reach patients sooner, according to Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER).

The feds have “a long way to go” to get the Open Payments system operating effectively and user friendly, according to officials in charge of the financial disclosure program.

The 2014 mid-term elections handed over control of the Senate to Republicans and boosted the GOP majority in the House, a clear blow to Obama administration policies, including the president’s landmark health reform initiative.