House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval

The Council of the EU has not taken forward a proposal from the European Parliament that would require companies to disclose the transfers of value they make to health care professionals and health care organizations – lawyers weigh in on the diverging proposals.

Ireland’s current voluntary system for disclosing pharmaceutical company payments to health care professionals and organizations is flawed and does not adequately deal with conflicts of interests, according to an Irish law maker.

Lawyers explain how changes to rules around drug advertising and promotional activities under the EU pharma reform package could impact companies operating in the bloc, with one legal expert advising companies to “monitor developments closely.”

The budget reconciliation bill nears final passage without pharmacy benefit manager reforms or provisions that would facilitate access to cell and gene therapies for children, but its Medicaid cuts pose a significant threat to prescription drug access.