Reps. McKinley and Kaptur ask commissioner Hahn about potential for shortages if Teva’s proposal to provide free opioid addiction treatment goes into effect. States are pushing for more money and stricter injunctive terms in settlement talks with manufacturers and distributers.
Teva Pharmaceutical Industries Ltd.’s proposal to resolve US opioid litigation with free opioid addiction treatment is facing opposition from a new front as members of Congress express concern that the plan could disrupt drug supply from other manufacturers. And in an unusual move, they are attempting to get the US Food and Drug Administration to weigh in on the plan.
Reps. David McKinley, R-WV, and Marcy Kaptur, D-Ohio, sent a 17 August letter to FDA commissioner Stephen Hahn nearly...
Innovator drug advocates argued that the number of patents asserted by industry is not too dissimilar to other fields. But should drugs be compared to golf balls?
At Medicines for Europe’s legal affairs conference last month, divisional patents were once again a major subject of discussion. Attendees heard fresh details of how patentee games are preventing generics from hitting the market and restricting wider access to major medicines.
The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.
The FDA concluded that generic tasimelteon products held by Teva and MSN Labs meet all statutory bioequivalence requirements and there was no “mistake” or untrue statement in the original ANDA approvals.
The US FDA says its release of complete response letters for products subsequently approved by the agency is just a first step toward releasing rejection letters when they are issued, assuming legal issues can be resolved.
The FDA's recent announcement of plans to expand unannounced inspections at ex-US facilities should put firms on advance notice that their next foreign facility inspection may not be preannounced, Ivy Sweeney, acting head of the agency's drug inspections office said.
New US FDA drugs center director George Tidmarsh’s data-centric comments at a Reagan-Udall Foundation meeting on unapproved fluoride products could suggest patients’ and caregivers’ experiences will carry less weight in benefit-risk decisions under his leadership.
