By Kurt R. Karst – As the years go by and nostalgia creeps in, we reminisce about the past and how things were “back then” (which to this blogger means the 1980s and 1990s). It’s not that things were necessarily better “back then,” they were just …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is happy to announce that five of the firm’s attorneys have been named “Super Lawyers” in the Washington, D.C. area in the 2015 Washington DC Super Lawyers Magazine. Super Lawyers is a rating service of outstanding lawyers from more …
By Alexander J. Varond – On July 10, 2015, the U.S. House of Representatives passed the 21st Century Cures Act. In all, there were 344 “yes” votes and only 77 “no” votes, with half of the “yes” votes coming from Republicans and the other half coming …
By James C. Shehan – On July 9, 2015, Representatives Matt Salmon (R- AZ), Paul Gosar (R-AZ) and Marlin Stutzman (R-IN) introduced H.R. 3012, the Right to Try Act of 2015. The bill seeks to expand the access of terminally ill patients to experimental drugs in …
By Etan J. Yeshua – Last week, FDA announced that it will be extending by one year the compliance date for its menu labeling rule. This means that restaurants and other establishments covered by the rule, and by the menu labeling provisions of the Affordable Care …
By Alexander J. Varond – FDA recently issued its final rule on permanent discontinuance or interruption in manufacturing of certain drug or biological products. To those familiar with the proposed rule issued in 2013, a review of the final rule will not bring many surprises. We …
By Ricardo Carvajal – The White House Office of Science and Technology Policy (OSTP) directed the three federal agencies charged with ensuring the safety of biotechnology products (FDA, USDA, and EPA) to undertake a review intended to “improve the transparency, predictability, coordination, and, ultimately, efficiency of …
By Kurt R. Karst – One of the more memorable lines from the original Star Wars Trilogy is uttered in Return of the Jedi when Luke Skywalker surrenders himself to Darth Vader on the Forest Moon of Endor. Luke tries to convince Vader to return to …
By Kurt R. Karst – The Orphan Drug Tax Credit (“ODTC”) is not an incentive you hear about all too often, but it’s been around for quite some time – since the enactment of the Orphan Drug Act of 1983 – and is a strong incentive …
The American Conference Institute (“ACI”) will hold its 26th FDA Boot Camp conference in Boston, Massachusetts from September 30 to October 1, 2015. A copy of the conference program can be obtained here. Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will co-chair the event with …
By James E. Valentine* – The enactment of FDASIA, including the fifth reauthorization of PDUFA, really put patient engagement on the radar beyond some of the traditionally active disease communities (e.g., HIV/AIDS, cancer, neurological diseases). FDASIA’s section 1137, the provision on Patient Participation in Medical Product …
By Andrew J. Hull* – Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for …
By Ricardo Carvajal – As directed under FSMA, FDA issued draft guidance on its approach to implementation of the Voluntary Qualified Importer Program (VQIP). In exchange for voluntarily subjecting themselves to an initial round of heightened scrutiny, importers who are approved for participation in the program …
By Jennifer D. Newberger – Devices intended to be reprocessed and used on more than one patient are required to be directly marked with a unique device identifier (UDI). 21 C.F.R. § 801.45. If, however, the direct marking “would interfere with the safety or effectiveness of the …
By Andrew J. Hull* - On June 22, three major pharmacists associations signed a letter to FDA asking the agency to use its enforcement discretion as pharmacies struggle to create appropriate product-tracing policies and practices before the July 1 compliance deadline under the Drug Supply Chain …
