Jill Wechsler, Pharm Exec’s Washington Correspondent

With one approved biosimilar under its belt, and dozens more under review and in development, FDA’s biosimilar development program is moving “beyond the finish line”. But agency officials still have much to do to address critical issues related to product analysis and testing.

Managing the nomination of new FDA commissioner adds to packed agenda

In testifying before Congress last week on FDA regulation of long-awaited biosimilars, CDER director Janet Woodcock emphasized that evaluation of new therapies should be based on sound science. Jill Wechsler reports.

September 22, 2015.

This week, the White House nominated Robert Califf to head FDA, long after he came to the agency in January 2015 as deputy commissioner for medical products and tobacco. But will he be confirmed, asks Jill Wechsler.

September 17, 2015.

Amarin ruling puts pressure on FDA to re-assess marketing rules

As the U.S. Open Payments system improves operations and resolves discrepancies, the emergence of widely diverse and contradictory transparency programs in Europe and other nations raises new challenges for pharma, writes Jill Wechsler.

The latest organization to join the cost-effectiveness stampede is the National Comprehensive Cancer Network, which recently announced that it would add a new “tool” to its widely used guidelines that advise oncologists on cancer treatment strategies. Jill Wechsler reports.

The Reagan-Udall Foundation for the FDA (RUF) is overcoming initial roadblocks and gaining support from a range of public and private organizations, writes Jill Wechsler.

Manufacturers seek gradual rollout of more targeted FDA quality metrics program.

FDA needs to expand and empower its Office of Health & Constituent Affairs (OHCA) and its Patient Liaison Program to better coordinate interactions with individuals and physicians seeking expedited access to experimental therapies

FDA reform may get tangled up in user fee negotiations, budget debate

With biopharma companies increasingly accused of bankrupting the health care system with high prices, news that ICER has received a $5.2 million grant to expand its analyses of drug cost-effectiveness could be a game changer, writes Jill Wechsler.

FDA has launched the process for reauthorizing the Prescription Drug User Fee Act (PDUFA), setting the stage for FDA to hear the views of patient, consumer and health professional representatives. Jill Wechsler reports.

The budget increase for NIH brought strong support from the biomedical research community and medical societies across the board.

FDA wants pharma to be more selective in seeking special status for promising therapies

Conversely, social media discussions about study requirements and procedures may discourage participation and undermine study integrity, according to experts at last week’s Drug Information Association (DIA) annual meeting in Washington, D.C.

Jill Wechsler cast her eye over FDA acting commissioner Stephen Ostroff's international plans.

Drug quality issues have forced the National Institutes of Health to shutter its in-house facility for producing clinical supplies for certain clinical trials.

New proposals from Congress to spur innovation will strain resources needed for regulatory approval, writes Jill Wechsler.

New proposals from Congress to spur innovation will strain resources needed for regulatory approval.

Widespread use and abuse of opioid painkillers is prompting efforts to develop new drugs and formulations that resist abuse while providing relief to legitimate patients, writes Jill Wechsler.

The House Energy & Commerce (E&C) Committee unanimously approved the 21st Century Cures legislation last week, but the debate is slated to continue for several months, if not longer. Jill Wechsler reports.

After hearing “strong views” on the issue, FDA is expected to release biosimilar-naming guidance later this year.

Current clinical trials are regarded as “too slow, too expensive, not reliable, and not designed to answer the important questions,” according to FDA’s new deputy commissioner for medical products &tobacco, Robert Califf.

Insurers and payers demand lower prices-along with quality and innovation.

The revised Cures proposal makes it easier for pharma to distribute journal articles and medical textbooks to physicians, but it also drops provisions that provided added exclusivity for certain new therapies.

Demands from patient advocacy groups for broader subgroup representation in clinical trials has generated a new drug trial transparency initiative at the Center for Drug Evaluation and Research (CDER).

The industry continues to puzzle over FDA's proposed regulation of mobile medical apps (MMAs), writes Jill Wechsler.