Jill Wechsler, Pharm Exec’s Washington Correspondent

November 20, 2015.

There’s renewed optimism in the biomedical research community that years of effort finally may begin to pay off for developing cutting-edge gene and cellular treatments for debilitating and life-threatening conditions. Jill Wechsler reports.

The Senate hearing to weigh the appointment of Robert Califf to be the next commissioner of FDA was a fairly friendly event, with mostly softball questions about policies and programs. Jill Wechsler reports.

November 18, 2015.

Large pharma companies have fallen “below legal and ethical standards” for making public information from the relevant clinical trials, according to a report from Bioethics International.

November 17, 2015.

The Generic Pharmaceutical Association has called for policy makers to take steps to promote the development of competitive generic therapies and of biosimilars.

November 11, 2015.

After months of anticipation, pharma marketers continue to wait for FDA to update its policies governing sponsor communications involving unapproved drug uses. Jill Wechsler reports.

Doctors, advocates, politicians, and even the Feds have jumped on the price-gouging bandwagon. Jill Wechsler reports.

Doctors, advocates, politicians, feds jump on price-gouging bandwagon

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 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

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.