Iowa lawmaker launches probe into orphan drug pricing | CMC amendment filed to FDA by BriaCell for vaccine trial | FDA requires 1,000-patient late-stage trial for Armetheon's anticoagulant NDA
February 13, 2017
FDLI SmartBrief
News for the food and drug law community
Drugs & Biologics
Iowa lawmaker launches probe into orphan drug pricing
Iowa lawmaker launches probe into orphan drug pricing
Grassley (Drew Angerer/Getty Images)
An investigation into potential abuse of Orphan Drug Act provisions has been initiated by Sen. Chuck Grassley, R-Iowa, who plans to meet with interested groups and other Senate staff members to get their views and reach consensus on how to fix the problem. An analysis from Kaiser Health News, which suggested that the provisions of the act are being manipulated by some drug manufacturers to increase drug prices, maximize profits and protect niche markets, prompted the senator to launch the investigation.
Regulatory Focus (2/10),  BioCentury (2/10) 
CMC amendment filed to FDA by BriaCell for vaccine trial
A chemistry, manufacturing and control amendment has been filed by BriaCell Therapeutics to the FDA concerning a new batch of BriaVax -- a whole cell vaccine candidate indicated for patients with stage IV breast cancer -- and its BriaTest cell line testing platform. The firm plans to start Phase I/IIa trials for the vaccine candidate before the end of next month if the FDA accepts the amendment. (2/13) 
FDA requires 1,000-patient late-stage trial for Armetheon's anticoagulant NDA
Under an agreement with the FDA, Armetheon must conduct a single, 1,000-patient Phase III trial for its oral anticoagulant drug candidate tecarfarin before submitting a new-drug application, which is expected to happen in 2019. The drug is recommended for patients who need anticoagulation with a vitamin K antagonist, including those with prosthetic heart valves, chronic kidney disease or repeat deep vein thrombosis.
European Pharmaceutical Review (U.K.) (2/10) 
Senate confirms Price as HHS secretary
Senate confirms Price as HHS secretary.
Price (Alex Wong/Getty Images)
The Senate has voted 52-47 to confirm Rep. Tom Price, R-Ga., as HHS secretary. Price, an orthopedic surgeon who has held a House seat since 2005, has backed repeal of the Affordable Care Act and conversion of Medicaid to a block grant program.
The New York Times (free-article access for SmartBrief readers) (2/10) 
Register now for the Practical Food Law Seminar
The Practical Food Law Seminar is scheduled for March 21- 23, 2017 in San Francisco, CA. This seminar provides a presentation of food safety provisions, including labeling and advertising issues. Click here to register.
Global Focus
Use of Actelion's PAH treatment to continue, EMA panel says
The use of Actelion's pulmonary arterial hypertension treatment Uptravi, or selexipag, may continue as long as it will be used in line with current prescription information, according to a European Medicines Agency drug safety panel. The drug's link to the deaths of five patients taking the medicine in France is still under investigation.
Reuters (2/10) 
AstraZeneca's COPD treatment rejected by NICE
AstraZeneca's Daxas, or roflumilast, was rejected by the National Institute for Health and Care Excellence for National Health Service use as an add-on to bronchodilator treatment for severe chronic obstructive pulmonary disease in adults with frequent exacerbations and chronic bronchitis. NICE did not consider the drug cost-effective after calculating the firm's base case incremental cost effectiveness ration per quality-adjusted life year gained.
PharmaTimes (U.K.) (2/10) 
EU grants 2 patents to RepliCel's multineedle dermal injection technologies
Two European patents have been granted to RepliCel Life Sciences' multineedle dermal injection technologies, with one validated in 14 member countries and the other to be validated soon. The patents cover RCI-02, a device being developed for injecting dermal fillers, hair restoration and skin rejuvenation products. (India) (2/13) 
Food & Dietary Supplements
Sargento Foods issues nationwide recall of cheese products due to listeria risk
Seven cheese products from Sargento Foods are being recalled nationwide after the firm was notified by supplier Deutsch Kase Haus that the Longhorn Colby cheese used in their products may have been contaminated with listeria. The items directly affected by the listeria contamination include Sargento's Ultra Thin Sliced Longhorn Colby and Chef Blends Shredded Nacho & Taco cheeses, but five other cheeses were also recalled because they were packaged on the same line.
CNN (2/13),  WNBC-TV (New York City) (2/11) 
Possible contamination with metal pieces prompts recall of dog food
One lot of Grreat Choice Adult Dog Food with Chicken & Rice Classic Ground is being recalled by PetSmart online and in retail stores nationwide after the manufacturer received consumer complaints that the product might contain metal pieces. The recalled items are packed in 13.2-ounce cans, have the UPC number 7-3725726116-7 and best-by date of Aug. 5, 2019, and were sold from Oct. 10, 2016, to Feb. 7 of this year.
Food Poisoning Bulletin (2/11) 
Medical Devices
Open Payments program draws concerns from industry observers
The complexity of the CMS Open Payments program and problems with submission and validation of data continue to contribute to a costly administrative burden for manufacturers of medical devices, drugs and other supplies, industry observers say. Matthew Wetzel, vice president and assistant general counsel at AdvaMed, recommends that instead of an internal validation that usually relies on outdated data, the CMS should perform postsubmission audits on sample data sets.
Bloomberg BNA (free content) (2/10) 
Hot Topics
FDLI Items
Don't miss the Top 10 Cases in Food and Drug Law at the Annual Conference,
May 4-5, Washington, D.C.
Always informative and entertaining, the perennially popular session at FDLI's Annual Conference, "Top Cases in Food and Drug Law," promises insight into the most significant litigation from 2016 and a look at what to keep an eye on in 2017. Register now.
Introduction to US Food Law and Regulation, March 2-3, Washington, D.C.
Learn about pending regulations, food safety, food labeling, enforcement and related issues. Case studies, hypotheticals, and ample time for discussion are provided. Learn more.
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