Jill Wechsler, Pharm Exec’s Washington Correspondent

GOP critics of the Agency are planning more oversight of regulatory programs and policies. Jill Wechsler reports.

Jill Wechsler reports on how FDA is trying to finding a balance between clinical trials large enough to assess all relevant populations and small enough to include deep data on each patient.

January 05, 2016.

January 06, 2016.

The last few months have been tough for pharmaceutical companies, and the political environment in Washington isn’t likely to improve in the coming year, writes Jill Wechsler.

OND Director John Jenkins would like to see sponsors invest in more “me-better” drugs-as opposed to “me-too” medicines-to expand treatment options for patients and to boost competition among manufacturers.

The continuing attack on industry pricing and marketing jeopardizes coverage, R&D.

Jill Wechsler on why the FDA program that encourages biopharma companies to develop new treatments for rare and neglected diseases has been in the spotlight recently.

December 18, 2015.

Janet Woodcock, director of the Center for Drug Evaluation, highlights FDA's priority list for 2016.

The continuing campaign to ratchet down prescription drug prices has generated considerable talk about how compounders could provide less costly, alternative therapies. Jill Wechsler reports.

Drug pricing backlash threatens regulatory reform, R&D advances

December 02, 2015.

November 30, 2015.

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.

November 09, 2015.

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

The answer is perhaps not that much, according to some biosimilar developers, as well as payers and health plans. Jill Wechsler reports.

Public outrage over more high-priced drugs is undermining support for provisions in the House-passed 21st Century Cures legislation that provide additional exclusivities for developing certain new therapies, writes Jill Wechsler.

November 02, 2015.

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.