Amarin announced that its supplemental new drug application for Vascepa has been accepted for filing and granted Priority Review designation by the FDA; civil rights groups ask a federal court to strike down an HHS "conscience" rule that may limit services covered by providers and payers that violate religious or moral beliefs; US Representive Seth Moulton, D-Massachusetts, unveils a new military mental health proposal.
FDA Accepts sNDA for Amarin’s Vascepa, Grants Priority Review Designation
Amarin announced that its supplemental new drug application (sNDA) for Vascepa
has been accepted for filing and granted Priority Review designation by the FDA, according to a statement from the company.
The Prescription Drug User Fee Act goal date assigned by the FDA for the sNDA is September 28, 2019, which is 4 months earlier than the expected 10-month standard review for applications due to its Priority Review designation. The sNDA was based on findings from the REDUCE-IT cardiovascular outcomes study
, and if the indication is approved, Vascepa will be the first drug indicated to reduce residual cardiovascular risk in patients with statin-managed low-density lipoprotein cholesterol that have persistent elevated triglycerides.
Civil Rights Groups Ask a Federal Court to Strike Down HHS “Conscience” Rule
Lamba Legal and other civil rights groups have asked a federal court to strike down an HHS “conscience” rule that may create situations where healthcare providers, insurers, and other payers could refuse to cover services that they claim violate their religious or moral beliefs, The Washington Post
reported. The lawsuit was filed yesterday in the United States District Court for the Northern District of California and claims the policy, published May 21, is unconstitutional and exceeds HHS’ statutory authority. The plaintiffs emphasized that while transgender individuals may be most vulnerable to discrimination under the rule, it would affect all Americans. President Trump personally announced the rule during a speech before faith leaders who claim protections are necessary due to ineffectual enforcement of existing statutes that protect such decisions.
US Representative Unveils Military Mental Health Proposal
Representative Seth Moulton, D-Massachusetts, will introduce a plan Tuesday to expand military mental health services, POLITICO
reported. While the policy proposal has not yet been set in legislation, it would require mental health checkups in addition to annual physical exams for veterans and active-duty servicemen and mandate a counseling session for all troops within 2 weeks of their return from combat deployment. It would also provide funds for yearly mental health screening for every high school student in the country.