Michael McCaughan

Michael McCaughan

Editor-In-Chief of The Pink Sheet

Washington, DC

Latest from Michael McCaughan

Informed Consent Should Address Standard Of Care Risks, US FDA’s Califf Says

US FDA Commissioner Robert Califf offers some thoughts on improving the informed consent process during a Patient Engagement Advisory Committee meeting that reflect concerns informed consent documents are too long and complex, but also do not address everything that may be important to patients.

Trump’s Victory Could Bring Kennedy ‘Wild’ Card To FDA

Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.

The RFK ‘Wild’ Card: Uncertainty For US FDA In A Second Trump Term

Republican presidential candidate Donald Trump says he will let Robert F. Kennedy Jr. “go wild on medicines” if he wins the White House. That could spell challenges for the US FDA in 2025.

OTC Contraceptive Coverage Plan Includes Broader Rx Mandate

A proposed rule requiring US insurers to cover non-prescription birth control would also broaden the existing mandate to cover prescription contraceptives at no cost for beneficiaries.

Updating The IRA Math: Not As Bad For Pharma As It Looked?

The landmark drug pricing reforms from the Inflation Reduction Act are starting to take full effect – and it turns out that the impact may not be as dramatic as originally projected based on updated analyses from the US Congressional Budget Office.

Weight Loss Drug Coverage Will Not Pay For Itself, US CBO Affirms

The US Congressional Budget Office acknowledged that weight loss drug coverage could drive long term savings from ancillary health issues, but not enough to offset the cost of the drugs. Expanding Medicare coverage would cost the US Treasury $35 billion over 10 years.