Feb. 25, 2019 – Even as the Centers for Medicare & Medicaid Services considers comments received on a federal proposal to mandate the inclusion of the wholesale acquisition cost (WAC) of prescription drugs in consumer television ads, the state of Oregon is weighing whether or not to require a disclosure regarding the wholesale cost that […]
Read more
Jan. 15, 2019 – In comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposal to require that drug companies include the wholesale acquisition cost (WAC) of a drug in direct-to-consumer (DTC) television ads, industry trade groups and pharmaceutical companies largely are in agreement that doing so would confuse consumers, that CMS […]
Read more
Jan. 22, 2018 – The House Energy and Commerce Subcommittee on Health held a markup Jan. 17 that advances H.R. 2026 (http://bit.ly/2G4cRM1), the “Pharmaceutical Information Exchange Act,” which will clarify how drug and medical device companies can share health care economic or scientific information about investigational drugs or devices with payers and formulary committees. “By […]
Read more Aug. 7, 2017 – In a 94-1 vote, the U.S. Senate on Aug. 3 passed FDA user fee reauthorization legislation that will revise and extend the user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products through 2022. H.R. 2430, the FDA Reauthorization Act of 2017, was passed by the House […]
Read more
Feb. 24, 2017 – The FDA recently published a final rule on intended use and adequate directions for use that establishes a not-previously-announced “totality of the evidence” standard and is in violation of the Administrative Procedures Act because it deprives stakeholders of fair notice and the opportunity to comment, according to a Feb. 8 […]
Read more Nov. 10, 2016 – As FDA Commissioner Robert Califf described the issues surrounding the communication of off-label uses as “numerous and complex” and cautioned that there are many instances where unapproved uses are “unsafe and ineffective,” industry speakers at an FDA hearing held Nov. 9 called on the agency to take immediate action and provide […]
Read moreOct. 6, 2104 – Although the FDA’s Office of Prescription Drug Promotion (OPDP) recently reopened the comment period for its two social media draft guidances, all three major industry trade associations – the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO) and the Advanced Medical Technology Association (AdvaMed) – already had […]
Read more