Jill Wechsler, Pharm Exec’s Washington Correspondent

January 30, 2017

Congress's enactment of 21st Century Cures legislation may have given pharmaceutical manufacturers an early Christmas present, but some concerns are being voiced, writes Jill Wechsler.

Republican control of Washington promises overhaul of healthcare and medical product regulation.

Congress took a major step yesterday towards shoring up FDA operations and biomedical research supported by the National Institutes of Health with House passage of the 21st Century Cures bill.

The surprise victory of Donald Trump opens the door to new strategies for providing healthcare to Americans, including coverage and oversight of prescription drugs.

Policymakers, payers and pharma companies weigh strategies for rationalizing drug prices . Jill Wechsler reports.

The FDA approved Sarepta’s Exondys for Duchenne muscular dystrophy despite little evidence of efficacy, leading many to regard the decision as not being a model for future drug development.

FDA’s new Office of Tissues and Advanced Therapies will oversee a growing range of cellular and genetic products.

Despite notable deficiencies in the frameworks for assessing the value of prescription drugs, these initiatives are expected to have a major impact on drug utilization and reimbursement.

PDUFA VI to enhance FDA staffing, revise fees and expand evidence for drug development.

PDUFA VI to enhance FDA staffing, revise fees and expand evidence for drug development.

The campaign to achieve greater transparency in clinical research activity regulated or funded by the federal government, including the results of those studies, is moving forward after months of debate.

Traditional sales and pricing practices face legal challenges and political backlash.

$7.5 billion in pharma “transfers of value” made in 2015 has caught the attention of the DoJ and federal and state prosecutors investigating fraud. Jill Weschler reports.

Traditional sales and pricing practices face legal challenges and political backlash, writes Jill Wechsler.

Analysts examine investment and business factors that shape supply disruptions.

Zika vaccine development is hindered by technical challenges and funding shortfalls, writes Jill Wechsler.

Stakeholders are looking to move up the Prescription Drug User Fee Act timeframe to gain Congressional action before the Obama administration steps down.

July 27, 2016

Rapid growth in Medicare spending on prescription drugs is prompting a leading advisory group to recommend significant revisions in how the government pays for medicines under Part D and Part B

Jill Wechsler on the need for more efficient methods of documenting treatment benefits in medical practice.

Rapid growth in Medicare spending on prescription drugs is prompting a leading advisory group to recommend significant revisions in how the government pays for medicines under Part D and Part B

Despite enthusiasm from payers and pharma companies for innovative drug reimbursement strategies linked to positive patient responses, negotiating such deals is no easy business.

June 13, 2016

There’s a stampede to relate prices to broader health benefits, but little consensus on how to do so, writes Jill Wechsler.

Sharing un-redacted inspection reports between FDA and EMA may reduce duplicate inspections of facilities.

There’s a stampede to relate prices to broader health benefits, but little consensus on how to do so, writes Jill Wechsler.

May 16, 2016.

Policymakers seek to limit prescribing while also encouraging innovative R&D.

Policymakers seek to limit prescribing while also encouraging innovative R&D.