May 19, 2014 – In May 15 comments to the FDA regarding its draft guidance on reprint practices for articles and medical texts that contain off-label information, the Washington Legal Foundation (WLF) stated that as written, the draft guidance violates a 1999 federal court injunction that prohibits the agency from preventing manufacturers from disseminating peer-reviewed […]
Read moreTag: WLF
WLFWLF to CMS: Deem Medical Textbooks Educational Materials or Face Potential First Amendment Challenge
May 16, 2013 – The Centers for Medicare & Medicaid Services (CMS) is likely “to find itself the target of a First Amendment lawsuit by affected parties” if it does not consider medical textbooks to be “educational materials that directly benefit patients” which are excluded from a reporting requirement under the final rules implementing the […]
Read moreExecutive Director of Coalition Says Stark Proposals Violate the 1st Amendment
From Washington Legal Foundation: On June 21, 2007, U.S. Representative Pete Stark introduced a bill titled the “Fair Balance Prescription Drug Advertisement Act of 2007.” H.R. 2823 (110th Cong., 1st Sess.). If enacted, the bill would deny a tax deduction for any expenses associated with a direct-to-consumer (“DTC”) advertisement for a new prescription drug for […]
Read more