Jill Wechsler

Chevy Chase

Washington Editor at Pharmaceutical Executive

Washington Editor at BioPharm International

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Articles

FDA, Industry Face Challenges in the Year Ahead

Dec 11, 2023 | pharmexec.com | Jill Wechsler

In the 30 years that I have been writing about FDA policy and biopharmaceutical research and drug manufacturing, I have not encountered a time as uncertain as the present. The political battles over medicines for abortion, vaccine safety, and shortages in vital treatments threaten to undermine long-held confidence and support for the nation's regulatory system for food, drugs, and medical products.
FDA Inspections Face Continued Overhaul and Changes

Oct 13, 2023 | appliedclinicaltrialsonline.com | Jill Wechsler

Published on: Applied Clinical Trials, Applied Clinical Trials-10-01-2023, Volume 32, Issue 10Agency will be reorganizing field force and compliance functions. As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for all regulated products, at home and abroad.
FDA Inspections Face Overhaul

Sep 28, 2023 | pharmtech.com | Jill Wechsler

Published on: The agency will be reorganizing field force and compliance functions. US Capital Building. | Image Credit: © W.Scott McGill - © W.Scott McGill - stock.adobe.comAs part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for all regulated products, at home and abroad.
FDA Inspections Face Overhaul

Sep 27, 2023 | biopharminternational.com | Jill Wechsler

Published on: The agency will be reorganizing field force and compliance functions. As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for all regulated products, at home and abroad.
Industry Challenges Medicare Price Negotiation Scheme

Aug 3, 2023 | pharmtech.com | Jill Wechsler

Published on: Jill WechslerPharmaceutical Technology, Pharmaceutical Technology, August 2023, Volume 47, Issue 8Pages: 14-15Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan. US Capital Building.
Industry Challenges Medicare Price Negotiation Scheme

Aug 1, 2023 | biopharminternational.com | Jill Wechsler

As the federal government began to roll out the rules and procedures for negotiating prices of drugs reimbursed by Medicare Part D plans, biopharma companies launched an attack on the legality of the controversial program. Merck took the lead in filing a detailed lawsuit on June 6, 2023 in the Washington, D.C. federal district court, claiming that the negotiation process established by the Inflation Reduction Act (IRA) violates the constitutional rights of manufacturers (1).
Congress Leaves Town with Major Drug-Related Bills on Hold

Jul 28, 2023 | pharmtech.com | Jill Wechsler

House and Senate committees made some progress on legislation to support national preparedness and response to future pandemics, which has to be reauthorized before it expires Sept. 30, 2023. But that tight timeframe for passing the Pandemic All Hazards and Preparedness Act (PAHPA) is encouraging lawmakers to include various pet programs and policies in the measure.
Congress Leaves Town with Major Drug-Related Bills on Hold

Jul 28, 2023 | pharmexec.com | Jill Wechsler

The legislators departed Washington, DC this week for a six-week summer recess without passing a host of critical budget bills, including key measures involving healthcare and drug regulation. At the top of the legislative to-do list are multiple appropriation bills to continue funding the federal government past Sept. 30. Another important measure on hold would reauthorize programs to prepare the nation for the next pandemic.
FDA Inspections Face Overhaul

Jul 21, 2023 | pharmexec.com | Jill Wechsler

As part of agency initiatives to strengthen its oversight of human food and food products, FDA is revising inspection and compliance programs for drugs and medical products, at home and abroad. While the current goal is to improve FDA's capability for monitoring and curbing contamination issues involving foods, the agency also proposes significant changes in oversight and inspection programs for medicines and other regulated products.
Large Clinical Trial Supports Alzheimer Drug Full Approval

Jul 11, 2023 | pharmtech.com | Jill Wechsler