By Jay W. Cormier & Alan M. Kirschenbaum – Last summer, the Health Resources and Services Administration (“HRSA”) promulgated a final regulation to implement a statutory provision, added by the Affordable Care Act, that excludes orphan drugs from the ceiling price limitations of the 340B Program …
By Ricardo Carvajal – FDA filed a motion to dismiss the lawsuit brought by the Center for Food Safety challenging the legality of FDA’s GRAS notification program (for background information on the lawsuit, see our prior posting here). In its supporting memorandum, FDA argues that plaintiff …
By Kurt R. Karst – We’re not sure if it was merely the passage of time or something else that relieved the constipation, but FDA has finally acted on an October 24, 2008 Notice for an Opportunity for Hearing (Docket No. FDA-2008-N-0549) proposing to withdraw approval …
The American Conference Institute (“ACI”) will hold its 5th annual Summit on Biosimilars from June 5-6, 2014 at the InterContinental New York Barclay, New York, New York, and a pre-conference primer on June 4th with sessions titled “Biosimilars 101: Comprehensive Deep Dive Into the Relevant …
By Alan M. Kirschenbaum – CMS has posted relevant dates, instructions and other information regarding “Phase 2” of the 2014 reporting process under the Physician Payment Sunshine Act. (Background on this law and the 2014 reporting process can be found here.) CMS announced that Phase 2 of …
By James C. Shehan – According to St Francis of Assisi, “where there is charity and wisdom, there is neither fear nor ignorance.” As we contemplate the policy changes announced in the just-issued OIG Supplemental Special Advisory Bulletin on Independent Charity Patient Assistance Programs (PAPs), we …
By Alexander J. Varond & James E. Valentine – On May 20, 2014, Hyman, Phelps & McNamara, P.C.’s Frank J. Sasinowski appeared on a panel before the House Energy and Commerce’s Subcommittee on Health to present testimony at the first hearing on the 21st Century Cures …
By Kurt R. Karst – Earlier this week, the U.S. District Court for the District of Maine came one step closer to a merits ruling in a lawsuit filed last September by two Maine pharmacists, three Maine trade associations (the Maine Pharmacy Association, Maine Society of …
By Riëtte van Laack – FDA’s proposed rule regarding nutrition labeling (see our previous post here) will have far-reaching consequences that may not be obvious. For example, FDA intends to make major changes in its approach to defining and measuring dietary fiber – changes that could …
By Kurt R. Karst – In a May 14, 2014 Order following a hearing earlier that day, Judge Ellen Segal Huvelle of the U.S. District Court for the District of Columbia granted on ripeness grounds FDA’s Motion to Dismiss a lawsuit brought by Teva Pharmaceutical Industries …
By Riëtte van Laack – In 2011, the National Organic Program (“NOP”) of the USDA announced the availability of a draft guidance for “Made with Organic” claims. Of the four categories of organic claims (“100% organic,” “organic,” “made with organic,” “x% organic”), this category of organic …
By Jessica A. Ritsick & William T. Koustas – On May 8th and 9th, FDA got the ball rolling on the implementation of Title II of the Drug Quality & Security Act (“DQSA”), the Drug Supply Chain Security Act (“DSCSA”), by hosting a public workshop for …
By James C. Shehan – As previously reported here, in February 2012, FDA released three highly-anticipated guidances on biosimilars. Those of us interested in biosimilars have naturally been eagerly awaiting the next usual step in the process, the issuance of final guidances and perhaps the first …
By Ricardo Carvajal – FDA issued a draft guidance for industry that sets out the agency’s expectations for the content of petitions and notifications for exemption from food allergen labeling requirements. To date, such petitions and notifications have met with very limited success – a situation …
By Riëtte van Laack – The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new …
