Jill Wechsler, Pharm Exec’s Washington Correspondent

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

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

April 21, 2016.

April 12, 2016.

More than a year after approving its first biosimilar, FDA has authorized a second therapy in this category.

Despite research by eminent scientists as to the safety and benefits of immunization for children and adults, the anti-vaccine film "Vaxxed: From Cover-Up to Catastrophe” has all the emotional elements to convince millions that vaccines are unsafe and dangerous, writes Jill Wechsler.

April 04, 2016.

The courts, pharma, and policymakers push FDA to rethink communications policy.

Doctors and oncologists agree with pharma companies in opposing the latest proposal from the CMS to revise how it pays for drugs administered in doctors’ offices.

March 10, 2016.

More generics and biosimilars may generate competition - but FDA opposes broad compounding, writes Jill Wechsler.

More generics and biosimilars may generate competition - but FDA opposes broad compounding.

Clinical trials are challenging because pain is subjective, making it hard to define objective endpoints or to compare one drug to another.

March 03, 2016.

Various factors have altered the landscape for exchange of information on drugs and medical products, but the FDA has not kept pace in updating its rules governing what marketers can say about their therapies, writes Jill Wechsler.

March 02, 2016.

February 26, 2016.

FDA needs to make major changes in how it evaluates R&D of new combination therapies for cancer and other serious conditions, say patient advocates, cancer specialists and biopharma companies.

February 26, 2016.

After eight years in development, FDA is looking to expand its Sentinel system to play a more visible role in assessing medical product efficacy, as well as safety.

18 February, 2016.

February 18, 2016.

February 11, 2016.

February 12, 2016.

There was scant praise from the medical community for the eighth and final budget plan from the Obama administration.

Vaccine R&D has grown exponentially in recent years, spurred by ethical and medical needs to combat lethal infectious outbreaks and increased funding from public and private agencies and organizations.

February 08, 2016

Can the feds negotiate Medicare Part D prices? Jill Wechsler reports.

The development of more complex biopharmaceutical therapies that merit accelerated evaluation and approval has put pressure on FDA to speed up its review process.

Valeant and Turing's fuzzy explanations of pricing practices to the House Oversight and Government Reform Committee cast a shadow over the broader industry, writes Jill Wechsler.