By Jeffrey K. Shapiro – There has been a lot of talk about hostage taking during the recent federal government budget impasse. But Congress is not the only one taking hostages in Washington. The recent draft Medical Device Reporting (MDR) guidance reminds us (pp. 4-5) …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Kermit L. Jones, J.D., M.D. has joined the firm as an Associate. Prior to joining the firm, Dr. Jones served as a 2012-2013 White House Fellow assigned to the Secretary of Health and Human Services, …
By Riëtte van Laack & Ricardo Carvajal – On September 19, 2013, Cargill entered into a $5 million settlement agreement to dispose of a class action lawsuit regarding its advertising for Truvia® products as “natural.” Plaintiffs charged that the products are not natural because they …
By Jay Cormier & Alan Kirschenbaum – The Patient Protection and Affordable Care Act made extensive changes to the 340B drug discount program, which we have previously described. Among other things, the statute expanded the categories of covered entities entitled to purchase drugs at the …
By Kurt R. Karst – It was not a question of whether, but when FDA would issue its first Warning Letter to a facility covered by the Generic Drug User Fee Amendments of 2012 (“GDUFA”) that failed to self-identify its facility and pay applicable user fees. …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
By William T. Koustas & Jessica A. Ritsick – With California’s electronic pedigree requirement set to take effect in 2015, we have been following recent efforts by Congress to enact a national prescription drug track and trace system (see our previous posts here, here, here, …
By William T. Koustas – We have previously reported (here and here for example) on the litigation between Regenerative Sciences, LLC (“Regenerative”) and FDA. Regenerative is a Colorado company that owns a medical procedure known as the Regenexx Procedure. It is a non-surgical procedure by …
By Jeffrey K. Shapiro – As everybody has noticed, FDA finalized its guidance on Mobile Medical Applications earlier this week. We blogged on the draft version here. The final guidance is similar to the draft guidance – but with improved clarity. Hence, it has expanded from …
By Allyson B. Mullen – Have you ever heard of an “Immediately in Effect (IIE)” guidance document? Thanks to a new draft SOP issued by CDRH, you may soon see this new species of guidance on a regular basis. In section 405 of Food and Drug …
By Kurt R. Karst – Anyone from the United States who has visited a foreign city – like São Paulo, Brazil or Mumbai, India – knows immediately upon exiting the sealed environment of their aircraft that they are no longer in the United States. There’s …
By Jeffrey N. Wasserstein & Alexander J. Varond – Last week, ahead of the September 23, 2013 compliance deadline for its HITECH final rule (also referred to as the “Omnibus Final Rule”), the Department of Health and Human Services issued guidance entitled “The HIPAA Privacy …
By Kurt R. Karst – FDA’s latest Report to Congress, required by FDC Act § 505(q)(3), on the Agency’s experience with so-called “505(q) citizen petitions” during Fiscal Year 2012 (“FY2012”) is largely a rehash of the FY2011 Report to Congress (see our previous post here on …
By Jennifer D. Newberger – At long last, it is here: FDA has issued the final rule implementing the unique device identifier (UDI) requirements, originally required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and then again by the Food and Drug …
By Ricardo Carvajal – Rep. Frank Pallone (D-NJ) introduced legislation – H.R. 3147, the Food Labeling Modernization Act of 2013 – that would grant FDA significant new authorities in the area of food labeling. In what is identified as the bill’s “signature initiative,” FDA would be directed to establish …
