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Drugmakers want to see changes to interim rules adopted last month for the transitional Medicare drug discount card that would ensure pricing information remains confidential, provide flexibility for off-label uses and allow appropriate coverage of first-in-class drugs, according to comments released by the Centers for Medicare & Medicaid Services (CMS) last week.
Drugmakers have identified several improvements they would like to see made to interim rules adopted last month for the transitional Medicare drug discount card.
The new Medicare prescription drug law is setting up a highly competitive market that will result in vigorous price negotiations between drug manufacturers and healthcare plans, according to PhRMA officials.
Drugmakers not only support a recent move by a major accreditor of continuing medical education (CME) providers to ensure that scientific experts aren’t excluded from CME programs based solely on their connections to pharma firms, but add they would like to see conflict of interest rules applied equally to nonprofit CME sponsors, according to an official at PhRMA.
Transkaryotic Therapies (TKT) said it has abandoned efforts to get FDA approval for Replagal, a treatment for Fabry disease, a rare genetic fat-storage disorder that leads to fatal complications.
Generic drugmakers may find tougher business conditions overseas as U.S. negotiators forge free-trade deals that strengthen drug patent rules and weaken price control schemes in regions such as the Middle East, Central America and the South Pacific.
For comparability protocols, the FDA should allow for reporting categories other than Prior Approval Supplements (PASs) if tests and studies do not meet predefined acceptance criteria, PhRMA told the agency in comments on a draft guidance on the protocols.